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srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img/https://asuragen.com/wp-content/uploads/2023/09/carrier-bg-600x128-c-default.jpg"> <source media="(max-width: 900px)" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img/https://asuragen.com/wp-content/uploads/2023/09/carrier-bg-1200x257-c-default.jpg"> <img decoding="async" loading="eager" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1440,h_500/https://asuragen.com/wp-content/uploads/2023/09/carrier-bg-1400x500-c-default.jpg" width="1440" height="500" alt=""> </picture> </div> <div class="curve"><svg viewBox="0 0 370 106" xmlns="http://www.w3.org/2000/svg"><g transform="translate(0,-110)"><path d="M0,215 C67,179 197,125 370,110 L0,110 L0,215 Z"></path></g></svg></div> </div> <div class="breadcrumbs"> <div class="bound-layout"> <nav> <a href="https://asuragen.com">Home</a><a>Carrier Screening Guide: How to Ensure Reliable Information for All Patients</a> </nav> </div> </div> <div class="bound-layout layout-sidebar"> <div class="content"> <div class="solutions-detail"> <div class="solution-description" id="solution-us"> <h1>Carrier Screening Guide: How to Ensure Reliable Information for All Patients</h1> <p>Updated information on cystic fibrosis, spinal muscular atrophy, and fragile X syndrome carrier screening for clinicians.</p> <p><strong><button><a href="https://asuragen.com/carrier-screening/clinician-carrier-screening-guide-for-cystic-fibrosis-spinal-muscular-atrophy-fragile-x/" rel="attachment wp-att-193147">Download The Carrier Screening Guide</a></button></strong></p> <nav class="solutions-nav stacked"> <a href="#us-1">Overview</a> <a href="#us-2">Cystic Fibrosis Carrier Screening</a> <a href="#us-3">Spinal Muscular Atrophy (SMA) Carrier Screening</a> <a href="#us-4">Fragile X Carrier Screening</a> <a href="#us-5">Conclusion</a> <a href="#us-6">References</a> </nav> <div id="us-1" class="solutions-detail-content"> <h3 class="solution-subtitle">Overview</h3> <h3>Advanced Genetic Testing Delivers More Reliable Results for Carrier Screening</h3> <p>Three of the conditions most frequently recommended for carrier screening are cystic fibrosis<br /> (CF), spinal muscular atrophy (SMA), and fragile X syndrome (FXS). Unfortunately, conventional<br /> approaches have tended to deliver uneven results across ancestries, and they often fail to detect<br /> more complex genetic variants with important clinical implications.</p> <p>Recently, the American College of Medical Genetics and Genomics (ACMG) updated its carrier<br /> screening guidelines<sup>1</sup>. The new recommendations emphasize the importance of adopting methods<br /> that produce meaningful results for patients of all ancestries — and of allowing physicians to make<br /> consistent carrier screening recommendations for all patients without having to base decisions on<br /> ancestry or ethnicity.</p> <p>Carrier screening is moving to a pan-ancestry model. This transition will offer enormous benefit to patients by ensuring more reliable results for all. However, getting there will require abandoning genetic tests that don’t hold up to this new standard, and ensuring that all carrier screening tests utilized are based on insights gleaned from diverse,<a href="https://asuragen.com/?attachment_id=193134" rel="attachment wp-att-193134"><img loading="lazy" decoding="async" class="size-medium wp-image-193134 alignright" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300,h_293/https://asuragen.com/wp-content/uploads/2022/02/greencallout-300x293.png" alt="acmg has updated its carrier screening guidelines" width="300" height="293" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/greencallout-300x293.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_660/https://asuragen.com/wp-content/uploads/2022/02/greencallout.png 660w" sizes="auto, (max-width: 300px) 100vw, 300px" /></a> population-scale data sets. In addition, these tests must be robust enough to reliably detect even the most challenging genetic variants.</p> <p>How does this affect carrier screening for commonly tested conditions including cystic fibrosis, spinal muscular atrophy and fragile X?</p> <p>Consider these important facts related to carrier screening for each disease:</p> <p> </p> <h3>Cystic fibrosis</h3> <ul> <li>95% of cystic fibrosis variant information in the “gold-standard” historical database is from<br /> people of European descent<sup>2</sup></li> <li>Multiple studies<sup>3,4</sup> have found the ACMG 23-variant recommendation to be insufficient for<br /> detecting cystic fibrosis carriers in diverse populations</li> <li>More variants do not guarantee more coverage: larger variant panels still lack sufficient<br /> coverage of diverse populations because they were designed based on ethnically<br /> homogeneous data<sup>3,5</sup></li> <li>People of non-European descent are less likely to be detected on prenatal and newborn<br /> screening tests even when they are carriers or have cystic fibrosis, due to use of panels lacking<br /> coverage for diverse populations<sup>6,7,8</sup></li> </ul> <h3>Spinal Muscular Atrophy</h3> <ul> <li>If a test is reporting<em> SMN1</em> copy number alone for carrier screening, there can be up to<br /> approximately 30% false negative results, depending on patient ancestry<sup>9</sup></li> <li>These false-negative results are due to “silent carriers” that have 2 copies of the<em> SMN1</em> gene,<br /> but both copies of the gene are on the same allele. Thus, a “silent carrier” can still pass on an<br /> allele with no copies of <em>SMN1</em> in this case. If both parents pass on alleles with no copies of<br /> <em>SMN1</em>, the child will have SMA.</li> <li>This “silent carrier” phenomenon is more common in people of African descent<sup>9</sup>, meaning<br /> determining the risk of “silent carrier” genotype may be very important in this demographic</li> </ul> <h3>Fragile X Syndrome</h3> <ul> <li>To determine the risk of a potential carrier having a child with fragile X, triplet repeats (CGGs)<br /> in the <em>FMR1</em> gene must be quantified. However, it is difficult for many technologies to quantify<br /> these repeats accurately.</li> <li>In addition, there are triplet-repeat interrupting sequences (AGGs) that can significantly alter<br /> the risk of certain women for having a child with Fragile X<sup>4,10,11</sup>. For example, quantifying AGG<br /> interruptions adjusts the risk for 90% of certain female carriers compared to CGG repeats<br /> alone<sup>4</sup>, but clinicians may not be receiving this information for their patients.</li> </ul> <p>Fortunately, the public release of data from diverse large-scale genomic studies has now made<br /> it possible to identify relevant genetic alterations across populations. By incorporating this<br /> information into carrier screening tests, and by building these tests with advanced technology<br /> capable of detecting all relevant genetic information regardless of complexity, modern carrier<br /> screening can deliver reliable results for all patients.</p> <p> </p> </div> <div id="us-2" class="solutions-detail-content"> <h3 class="solution-subtitle">Cystic Fibrosis Carrier Screening</h3> <p>Underrepresented genetic diversity in data sets is a common challenge in genomics today. The<br /> effects of this can be seen in diagnostic and carrier screening tools that provide more accurate and<br /> comprehensive results for some populations than for others.</p> <p>Consider these metrics about available genomic data sets: In 2009, an analysis of genome-wide<br /> association studies found that 96% of the 1.7 million samples reviewed came from individuals of<br /> European ancestry<sup>12</sup>. By 2021, data from the GWAS Diversity Monitor website<sup>13</sup> indicated that the<br /> share of GWAS samples from people with non-European ancestry had grown from that measly 4%<br /> to just 12%.</p> <p>The vast majority of historically available data supporting cystic fibrosis testing also comes from<br /> people of European descent. The prominent historical database<sup>2</sup> includes data from nearly 90,000<br /> patients on pathogenic variants detected in the <em>CFTR</em> gene, connecting patient genotype and<br /> phenotype. It has long been considered the gold standard on genetic data for cystic fibrosis.<br /> Unfortunately, of the patients represented in the database, 95% have European ancestry, leaving<br /> other populations woefully underrepresented (Figure 1).</p> <p> </p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts.png" rel="attachment wp-att-193135"><img loading="lazy" decoding="async" class="alignnone wp-image-193135 size-large" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024,h_258/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts-1024x258.png" alt="cftr2 database by ethnicity" width="1024" height="258" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts-1024x258.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts-300x76.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts-768x193.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts-1536x387.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1931/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts.png 1931w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></a></p> <p> </p> <p> </p> <p><strong>Figure 1.</strong> Illustration of the historical variant database<sup>2</sup> patient ethnicity compared to more realistic representation of U.S. population diversity<sup>3</sup>.</p> <p>To add to the challenges in <em>CFTR</em> testing, there have been over 2000 <em>CFTR</em> mutations documented<br /> <sup>14</sup>, with varying levels of pathogenicity. In order to provide practical cystic fibrosis<br /> carrier screening guidance for clinical laboratories, ACMG recommended testing for 23 of the<br /> most common mutations in 2004, based on available data at that time<sup>15</sup>.</p> <p><a href="https://asuragen.com/?attachment_id=193143" rel="attachment wp-att-193143"><img loading="lazy" decoding="async" class="size-medium wp-image-193143 alignleft" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300,h_300/https://asuragen.com/wp-content/uploads/2022/02/bluecallout-300x300.png" alt="44% of cystic fibrosis carriers would be missed using the ACMG-23 panel" width="300" height="300" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/bluecallout-300x300.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_150/https://asuragen.com/wp-content/uploads/2022/02/bluecallout-150x150.png 150w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/bluecallout-768x768.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_900/https://asuragen.com/wp-content/uploads/2022/02/bluecallout.png 900w" sizes="auto, (max-width: 300px) 100vw, 300px" /></a>Since then, several large-scale studies have reported the lack of coverage for diverse populations by the ACMG 23 recommended variants. One study of over 370,000 people with an ethnic distribution representative of the U.S. population found that 44% of carriers would have been missed using the ACMG 23 panel<sup>4</sup>. Another recent study of over 13,000 screened<br /> couples with an ethnic distribution representative of the U.S. population found that 31% of at-risk couples would have been undetected using the ACMG-23, which would have resulted in missed cases of cystic fibrosis<sup>3</sup>.</p> <p>Even more concerning is that most currently used targeted cystic fibrosis screening panels are at least five years old and were designed based on the historical database. Though these panels contain many more variants than the ACMG-23 panel, they still lack sufficient carrier screening coverage for the diverse U.S. population (Table 1). This is due to their design based on outdated and ethnically homogeneous data. The lack of coverage for specific ethnicities can further be seen for an on-market panel in Table 2.</p> <p><strong>Table 1.</strong> Three on-market <em>CFTR</em> panels with more variants detected than ACMG 23, but lacking sufficient cystic fibrosis carrier detection for the diverse U.S. population.</p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1.png" rel="attachment wp-att-193136"><img loading="lazy" decoding="async" class="aligncenter wp-image-193136" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_281/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-1024x288.png" alt="cftr assay panel comparison" width="1000" height="281" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-1024x288.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-300x84.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-768x216.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-1536x432.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-2048x576.png 2048w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p><strong>Table 2.</strong> Manufacturer-reported <em>CFTR</em> mutation detection rates of a commonly used <em>CFTR</em> targeted panel<sup>5</sup>. Reported coverage percentages are based on data published in 2004 or earlier, meaning coverage could be poorer if compared with more recently published, diverse datasets.</p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2.png" rel="attachment wp-att-193137"><img loading="lazy" decoding="async" class="aligncenter wp-image-193137" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_128/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-1024x131.png" alt="cftr percentages by ethnicity" width="1000" height="128" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-1024x131.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-300x38.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-768x98.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-1536x196.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-2048x262.png 2048w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p> </p> <p>However, universal carrier screening is recommended for cystic fibrosis, which means clinicians need results that accurately represent the risk of passing on this disease for patients of all ancestries.<br /> Large-scale population studies are adding rapidly to the information available about pathogenic variants associated with cystic fibrosis in people of diverse genetic backgrounds. Some of these studies deliberately gather data from diverse populations, such as that of the United States<sup>3,4</sup>. The rush of new, publicly-available genomic data represents significant progress in identifying relevant variants across ancestries.</p> <p>Still, this information must be incorporated into carrier screening tests to make a difference for prospective parents wondering if their children would be at risk of inheriting cystic fibrosis. Clinicians ordering carrier screening tests for cystic fibrosis should reach out to their clinical lab teams to ensure that such tests have been recently updated to reflect more diverse data sources — covering not only the most common variants found in the historical database but also diverse population-specific variants identified in large-scale sequencing studies.</p> <p> </p> </div> <div id="us-3" class="solutions-detail-content"> <h3 class="solution-subtitle">Spinal Muscular Atrophy (SMA) Carrier Screening</h3> <p>Until recently, a diagnosis of spinal muscular atrophy (SMA) was considered a death sentence. This debilitating neuromuscular disease is a leading genetic cause of death among infants. The introduction of game-changing therapies in the last few years, though, has brought new hope to families of affected individuals<sup>16</sup>.</p> <p>Though these therapies have been revolutionary, they do not negate the need for carrier screening. In fact, SMA carrier screening is recommended by the American College of Obstetricians and Gynecologists (ACOG) and ACMG for all women who are pregnant or planning to become pregnant<sup>1,17</sup>. SMA has a high carrier rate of approximately 1 in 50 individuals<sup>18</sup>.<a href="https://asuragen.com/?attachment_id=193138" rel="attachment wp-att-193138"><img loading="lazy" decoding="async" class="alignright size-medium wp-image-193138" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300,h_300/https://asuragen.com/wp-content/uploads/2022/02/orangecallout-300x300.png" alt="if measuring smn1 copy number alone, silent carrier genotypes can lead to up to 30% false negative results" width="300" height="300" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/orangecallout-300x300.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_150/https://asuragen.com/wp-content/uploads/2022/02/orangecallout-150x150.png 150w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/orangecallout-768x768.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_900/https://asuragen.com/wp-content/uploads/2022/02/orangecallout.png 900w" sizes="auto, (max-width: 300px) 100vw, 300px" /></a></p> <p>In addition, SMA screening accuracy can vary depending on ancestry. Historically, <em>SMN1</em> copy number was thought to be the only information needed for SMA carrier status: if a person had two copies of <em>SMN1</em> it was assumed they were on different alleles and the person could not pass on the disease to a child. Now it is known that conventional tests that report only <em>SMN1</em> copy number may miss “silent carriers”, or people who carry two copies of the <em>SMN1</em> gene on a single allele and no copies on the other allele (Figure 2). This silent carrier genotype can occur in any ethnicity, but it is more common among people of African ancestry<sup>9</sup>, so standard SMA screening tests may be more likely to miss carriers in this population. In fact, if reporting <em>SMN1</em> copy number alone, “silent carrier” genotypes can lead to approximately 30% false negative results for African American patients<sup>9</sup>.</p> <p> </p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart.png" rel="attachment wp-att-193139"><img loading="lazy" decoding="async" class="aligncenter wp-image-193139" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_401/https://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart.png" alt="smn1 false negatives chart" width="1000" height="401" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1086/https://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart.png 1086w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart-300x120.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart-1024x411.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart-768x308.png 768w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p><strong>Figure 2.</strong> Illustration of <em>SMN1</em> “silent carrier” genotype with two <em>SMN1</em> copies on the same allele (center), which can allow for passing on a zero copy allele, compared to a noncarrier genotype where one <em>SMN1</em> copy is present on each allele (right). One copy <em>SMN1</em> carrier genotype is on left. If receiving <em>SMN1</em> copy number results only, silent carriers cannot be distinguished since both center and right genotypes would yield results of 2 copies of <em>SMN1</em>.</p> <p> </p> <p>Fortunately, it has been observed that certain variants (called “linked variants”) in the <em>SMN1</em> gene can help predict silent carrier status. Presence of these variants can help further stratify carrier risk in all ethnicities, and even diagnose carrier status in a few<sup>19, 20</sup> (Table 3).</p> <p> </p> <p><strong>Table 3.</strong> Impact of positive results for an <em>SMN1</em> linked variant (c.*3+80T>G) on SMA carrier risk<sup>19, 20</sup> when positive for two <em>SMN1</em> copies, by ethnicity.</p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3.png" rel="attachment wp-att-193140"><img loading="lazy" decoding="async" class="aligncenter wp-image-193140" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_288/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3.png" alt="smn1 copy number and carrier frequency chart" width="1000" height="288" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2066/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3.png 2066w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3-300x86.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3-1024x295.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3-768x221.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3-1536x442.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3-2048x590.png 2048w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p>It is no longer enough to report only <em>SMN1</em> copy number for carrier screening. All SMA carrier screening tests should also include detection of these linked variants to provide patients with better information on potential carrier status.</p> <p>Furthermore, many commonly used tests for SMA are not as accurate or as sensitive as they should be when providing such vital clinical information. The test considered the gold standard for SMA testing is based on a cumbersome, time-consuming technology called MLPA. There has been some concern cited that this technology many not reliably distinguish certain copy numbers<sup>21</sup>. In addition, popular SMA screening technologies may not provide linked variant detection to inform carrier risk. Clinicians should check with their clinical lab teams to ensure they are using an SMA carrier screening test capable of providing this information.</p> <p> </p> </div> <div id="us-4" class="solutions-detail-content"> <h3 class="solution-subtitle">Fragile X Carrier Screening</h3> <p>Fragile X syndrome is the most common inherited form of intellectual disability and autism, affecting approximately 1 in 4,000 males and 1 in 5,000 females in the United States<sup>22</sup>. ACOG and ACMG recommend carrier screening for this syndrome<sup>1,17,23</sup>. However, of the estimated 1 million women believed to be Fragile X carriers in the U.S.<sup>22</sup>, the majority may be unaware of their carrier status.</p> <p>Fragile X syndrome is caused by a CGG repeat expansion in the <em>FMR1</em> gene on the X chromosome. Different counts of the repeat have different phenotypic outcomes (Table 4). Healthy individuals typically have fewer than 45 CGG repeats, while those who may be unaffected carriers or have associated disorders such as Fragile X-Associated Primary Ovarian Insufficiency (FXPOI) generally have between 55 and 200 repeats. Individuals with at least 200 repeats are diagnosed with Fragile X syndrome.</p> <p> </p> <p><strong>Table 4.</strong> Clinical categories and carrier status of mutations in the <em>FMR1</em> gene<sup>24,25,26</sup>.</p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4.png" rel="attachment wp-att-193141"><img loading="lazy" decoding="async" class="aligncenter wp-image-193141" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_675/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4.png" alt="fmr1 cgg repeats and clinical status, features and carrier status" width="1000" height="675" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2063/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4.png 2063w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4-300x202.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4-1024x691.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4-768x518.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4-1536x1036.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4-2048x1382.png 2048w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p><em>Abbreviations: FXS, fragile X syndrome; FXTAS, fragile X-associated tremor/ataxia syndrome; FXPOI, fragile X-associated primary ovarian insufficiency.</em></p> <p>For any genetic testing platform, obtaining an accurate count of so many repeated DNA triplets is a serious challenge. Additionally, many analysis platforms cannot accurately interrogate the region due to the technical challenges of assessing GC-rich DNA content. Therefore, it is important that fragile X carrier screening is being performed with robust technology that can analyze extreme GC content and provide accurate counts of CGG repeats in order to identify women at risk of having a child with fragile X.</p> <p> </p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB.png" rel="attachment wp-att-193142"><img loading="lazy" decoding="async" class="aligncenter wp-image-193142" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_489/https://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB.png" alt="number of cgg repeats and risk of expansion to full mutation" width="1000" height="489" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1328/https://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB.png 1328w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB-300x147.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB-1024x501.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB-768x376.png 768w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p><strong>Figure 3.</strong> AGG interruption quantification stratifies risk of expansion to full mutation in the next generation<sup>10,11,27</sup>. Risk by CGG repeat number only represented by blue line; 0 AGG interruptions detected, orange line; 1 AGG interruption detected, black line; 2 AGG interruptions detected, teal line. A 70 CGG patient example is illustrated where 21% risk is reported with CGG repeat-only information, which can be further stratified to range from 50% risk when 0 AGG interruptions (orange arrow) are detected to near 0% risk when 2 AGG interruptions are detected (teal arrow).</p> <p>Beyond CGG repeat counts, clinicians should also be provided information on AGG interruptions for women with 50 – 90 CGG repeats. In this select group, the number of AGG interruptions stratifies risk of expansion to a full mutation in offspring beyond that provided by CGG repeats alone (Figure 3). For example, for a woman with a 70 CGG repeat allele, risk of expansion to a full mutation can range from ~0% to 50% depending on the number of AGG interruptions. Information provided by the AGG interruption status can greatly affect reproductive decisions; thus, clinicians should work with their clinical lab partners to ensure they are providing this information for select patients.</p> </div> <div id="us-5" class="solutions-detail-content"> <h3 class="solution-subtitle">Conclusion</h3> <p>As insight into inherited diseases grows and diagnostic technology advances, providing all patients with accurate and relevant information must remain the central goal. Thankfully, due to the diligence of many scientists and clinicians, better tests have been developed for cystic fibrosis, spinal muscular atrophy, and fragile X carrier screening. As guidelines have shifted to pan-ethnic carrier screening, it is vital that clinicians and their clinical lab partners are aware of disparities and gaps in genetic information from often-used, yet outdated tests, and that they strive to provide more comprehensive and reliable information for all patients.</p> </div> <div id="us-6" class="solutions-detail-content"> <h3 class="solution-subtitle">References</h3> <p>1. Gregg AR, et al. Genet Med. 2021 Oct;23(10):1793-1806.<br /> 2. <span class="ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak" dir="ltr">Sosnay et al Nat Genet. 2013 Oct; 45(10): 1160–1167</span><br /> 3. Beauchamp KA, et al. Genet Med. 2019; 21(11): 2569–2576.<br /> 4. Westemeyer M, et al. Genet Med. 2020 Aug;22(8):1320-1328.<br /> 5. Luminex xTAG® Cystic Fibrosis (<em>CFTR</em>) 60 kit v2 product brochure.<br /> 6. McGarry ME, et al. Pediatr Pulmonol. 2019 Nov;54 (Suppl 3):S74-S83.<br /> 7. Watts KD, et al. J Genet Couns. 2012 Oct;21(5):671-5. doi: 10.1007/s10897-012-9481-2.<br /> 8. Neemuchwala F, et al. Case Rep Pediat. 2018 Jul 2;2018:7217326.<br /> 9. Hendrickson BC, et al. J Med Genet. 2009 Sep;46(9):641-4.<br /> 10. Nolin SL, et al. Genet Med. 2015 May;17(5):358-64.<br /> 11. Nolan SL, et al. Am J Med Genet A. 2013 Apr;161A(4):771-8.<br /> 12. Need AC and Goldstein DB. Trends Genet. 2009 Nov;25(11):489-94.<br /> 13. Mills MC and Rahal C. GWAS Diversity Monitor. 2021. <a href="https://gwasdiversitymonitor.com/" target="_blank" rel="noopener">https://gwasdiversitymonitor.com/</a><br /> 14. Veit G, et al. Mol Biol Cell. 2016 Feb 1; 27(3): 424–433.<br /> 15. Watson MS, et al. Genet Med. Sep-Oct 2004;6(5):387-91.<br /> 16. Nance JR. Spinal Muscular Atrophy. Continuum (Minneap Minn). 2020 Oct;26(5):1348-1368.<br /> 17. Rink B, et al. ACOG Opinion No 691. March 2017. Reaffirmed 2020.<br /> 18. Cure SMA. 2021. <a href="https://www.curesma.org/carriers-of-sma/" target="_blank" rel="noopener">https://www.curesma.org/carriers-of-sma/</a><br /> 19. Luo, et al. Genet Med. 2014 Feb;16(2):149-56.<br /> 20. Alías L, et al. Eur J Hum Genet. 2018 Oct;26(10):1554-1557.<br /> 21. Schorling DC, et al. Neurology. 2019 Aug 6;93(6):267-269.<br /> 22. National Fragile X Foundation. 2021. <a href="https://fragilex.org/" target="_blank" rel="noopener">https://fragilex.org/</a><br /> 23. Sherman S, et al. Genet Med. 2005 Oct;7(8):584-7.<br /> 24. Online Mendelian Inheritance in Man, OMIM®. Johns Hopkins University, Baltimore, MD. MIM Number: 300623. 2019. <a href="https://omim.org/" target="_blank" rel="noopener">https://omim.org/</a><br /> 25. Online Mendelian Inheritance in Man, OMIM®. Johns Hopkins University, Baltimore, MD. MIM Number: 300624. 2019. <a href="https://omim.org/" target="_blank" rel="noopener">https://omim.org/</a><br /> 26. Allen EG, et al. Genet Med. 2021 Sep;23(9):1648-1655.<br /> 27. Villate O, et al. Front Mol Biosci. 2020 Jul 14;7:135.</p> </div> </div> <div class="solution-description" id="solution-non-us"> <h1>Carrier Screening Guide: How to Ensure Reliable Information for All Patients</h1> <p>Updated information on cystic fibrosis, spinal muscular atrophy, and fragile X syndrome carrier screening for clinicians.</p> <p><strong><button><a href="https://asuragen.com/carrier-screening/clinician-carrier-screening-guide-for-cystic-fibrosis-spinal-muscular-atrophy-fragile-x/" rel="attachment wp-att-193147">Download The Carrier Screening Guide</a></button></strong></p> <nav class="solutions-nav"> <a href="#non-us-1">Overview</a> <a href="#non-us-2">Cystic Fibrosis Carrier Screening</a> <a href="#non-us-3">Spinal Muscular Atrophy (SMA) Carrier Screening</a> <a href="#non-us-4">Fragile X Carrier Screening</a> <a href="#non-us-5">Conclusion</a> <a href="#non-us-6">References</a> </nav> <div id="non-us-1" class="solutions-detail-content"> <h3 class="solution-subtitle">Overview</h3> <h3>Advanced Genetic Testing Delivers More Reliable Results for Carrier Screening</h3> <p>Three of the conditions most frequently recommended for carrier screening are cystic fibrosis<br /> (CF), spinal muscular atrophy (SMA), and fragile X syndrome (FXS). Unfortunately, conventional<br /> approaches have tended to deliver uneven results across ancestries, and they often fail to detect<br /> more complex genetic variants with important clinical implications.</p> <p>Recently, the American College of Medical Genetics and Genomics (ACMG) updated its carrier<br /> screening guidelines<sup>1</sup>. The new recommendations emphasize the importance of adopting methods<br /> that produce meaningful results for patients of all ancestries — and of allowing physicians to make<br /> consistent carrier screening recommendations for all patients without having to base decisions on<br /> ancestry or ethnicity.</p> <p>Carrier screening is moving to a pan-ancestry model. This transition will offer enormous benefit to patients by ensuring more reliable results for all. However, getting there will require abandoning genetic tests that don’t hold up to this new standard, and ensuring that all carrier screening tests utilized are based on insights gleaned from diverse,<a href="https://asuragen.com/?attachment_id=193134" rel="attachment wp-att-193134"><img loading="lazy" decoding="async" class="size-medium wp-image-193134 alignright" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300,h_293/https://asuragen.com/wp-content/uploads/2022/02/greencallout-300x293.png" alt="acmg has updated its carrier screening guidelines" width="300" height="293" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/greencallout-300x293.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_660/https://asuragen.com/wp-content/uploads/2022/02/greencallout.png 660w" sizes="auto, (max-width: 300px) 100vw, 300px" /></a> population-scale data sets. In addition, these tests must be robust enough to reliably detect even the most challenging genetic variants.</p> <p>How does this affect carrier screening for commonly tested conditions including cystic fibrosis, spinal muscular atrophy and fragile X?</p> <p>Consider these important facts related to carrier screening for each disease:</p> <p> </p> <h3>Cystic fibrosis</h3> <ul> <li>95% of cystic fibrosis variant information in the “gold-standard” historical database is from<br /> people of European descent<sup>2</sup></li> <li>Multiple studies<sup>3,4</sup> have found the ACMG 23-variant recommendation to be insufficient for<br /> detecting cystic fibrosis carriers in diverse populations</li> <li>More variants do not guarantee more coverage: larger variant panels still lack sufficient<br /> coverage of diverse populations because they were designed based on ethnically<br /> homogeneous data<sup>3,5</sup></li> <li>People of non-European descent are less likely to be detected on prenatal and newborn<br /> screening tests even when they are carriers or have cystic fibrosis, due to use of panels lacking<br /> coverage for diverse populations<sup>6,7,8</sup></li> </ul> <h3>Spinal Muscular Atrophy</h3> <ul> <li>If a test is reporting<em> SMN1</em> copy number alone for carrier screening, there can be up to<br /> approximately 30% false negative results, depending on patient ancestry<sup>9</sup></li> <li>These false-negative results are due to “silent carriers” that have 2 copies of the<em> SMN1</em> gene,<br /> but both copies of the gene are on the same allele. Thus, a “silent carrier” can still pass on an<br /> allele with no copies of <em>SMN1</em> in this case. If both parents pass on alleles with no copies of<br /> <em>SMN1</em>, the child will have SMA.</li> <li>This “silent carrier” phenomenon is more common in people of African descent<sup>9</sup>, meaning<br /> determining the risk of “silent carrier” genotype may be very important in this demographic</li> </ul> <h3>Fragile X Syndrome</h3> <ul> <li>To determine the risk of a potential carrier having a child with fragile X, triplet repeats (CGGs)<br /> in the <em>FMR1</em> gene must be quantified. However, it is difficult for many technologies to quantify<br /> these repeats accurately.</li> <li>In addition, there are triplet-repeat interrupting sequences (AGGs) that can significantly alter<br /> the risk of certain women for having a child with Fragile X<sup>4,10,11</sup>. For example, quantifying AGG<br /> interruptions adjusts the risk for 90% of certain female carriers compared to CGG repeats<br /> alone<sup>4</sup>, but clinicians may not be receiving this information for their patients.</li> </ul> <p>Fortunately, the public release of data from diverse large-scale genomic studies has now made<br /> it possible to identify relevant genetic alterations across populations. By incorporating this<br /> information into carrier screening tests, and by building these tests with advanced technology<br /> capable of detecting all relevant genetic information regardless of complexity, modern carrier<br /> screening can deliver reliable results for all patients.</p> <p> </p> </div> <div id="non-us-2" class="solutions-detail-content"> <h3 class="solution-subtitle">Cystic Fibrosis Carrier Screening</h3> <p>Underrepresented genetic diversity in data sets is a common challenge in genomics today. The<br /> effects of this can be seen in diagnostic and carrier screening tools that provide more accurate and<br /> comprehensive results for some populations than for others.</p> <p>Consider these metrics about available genomic data sets: In 2009, an analysis of genome-wide<br /> association studies found that 96% of the 1.7 million samples reviewed came from individuals of<br /> European ancestry<sup>12</sup>. By 2021, data from the GWAS Diversity Monitor website<sup>13</sup> indicated that the<br /> share of GWAS samples from people with non-European ancestry had grown from that measly 4%<br /> to just 12%.</p> <p>The vast majority of historically available data supporting cystic fibrosis testing also comes from<br /> people of European descent. The prominent historical database<sup>2</sup> includes data from nearly 90,000<br /> patients on pathogenic variants detected in the <em>CFTR</em> gene, connecting patient genotype and<br /> phenotype. It has long been considered the gold standard on genetic data for cystic fibrosis.<br /> Unfortunately, of the patients represented in the database, 95% have European ancestry, leaving<br /> other populations woefully underrepresented (Figure 1).</p> <p> </p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts.png" rel="attachment wp-att-193135"><img loading="lazy" decoding="async" class="alignnone wp-image-193135 size-large" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024,h_258/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts-1024x258.png" alt="cftr2 database by ethnicity" width="1024" height="258" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts-1024x258.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts-300x76.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts-768x193.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts-1536x387.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1931/https://asuragen.com/wp-content/uploads/2022/02/CFTR_piecharts.png 1931w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></a></p> <p> </p> <p> </p> <p><strong>Figure 1.</strong> Illustration of the historical variant database<sup>2</sup> patient ethnicity compared to more realistic representation of U.S. population diversity<sup>3</sup>.</p> <p>To add to the challenges in <em>CFTR</em> testing, there have been over 2000 <em>CFTR</em> mutations documented<br /> <sup>14</sup>, with varying levels of pathogenicity. In order to provide practical cystic fibrosis<br /> carrier screening guidance for clinical laboratories, ACMG recommended testing for 23 of the<br /> most common mutations in 2004, based on available data at that time<sup>15</sup>.</p> <p><a href="https://asuragen.com/?attachment_id=193143" rel="attachment wp-att-193143"><img loading="lazy" decoding="async" class="size-medium wp-image-193143 alignleft" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300,h_300/https://asuragen.com/wp-content/uploads/2022/02/bluecallout-300x300.png" alt="44% of cystic fibrosis carriers would be missed using the ACMG-23 panel" width="300" height="300" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/bluecallout-300x300.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_150/https://asuragen.com/wp-content/uploads/2022/02/bluecallout-150x150.png 150w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/bluecallout-768x768.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_900/https://asuragen.com/wp-content/uploads/2022/02/bluecallout.png 900w" sizes="auto, (max-width: 300px) 100vw, 300px" /></a>Since then, several large-scale studies have reported the lack of coverage for diverse populations by the ACMG 23 recommended variants. One study of over 370,000 people with an ethnic distribution representative of the U.S. population found that 44% of carriers would have been missed using the ACMG 23 panel<sup>4</sup>. Another recent study of over 13,000 screened<br /> couples with an ethnic distribution representative of the U.S. population found that 31% of at-risk couples would have been undetected using the ACMG-23, which would have resulted in missed cases of cystic fibrosis<sup>3</sup>.</p> <p>Even more concerning is that most currently used targeted cystic fibrosis screening panels are at least five years old and were designed based on the historical database. Though these panels contain many more variants than the ACMG-23 panel, they still lack sufficient carrier screening coverage for the diverse U.S. population (Table 1). This is due to their design based on outdated and ethnically homogeneous data. The lack of coverage for specific ethnicities can further be seen for an on-market panel in Table 2.</p> <p><strong>Table 1.</strong> Three on-market <em>CFTR</em> panels with more variants detected than ACMG 23, but lacking sufficient cystic fibrosis carrier detection for the diverse U.S. population.</p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1.png" rel="attachment wp-att-193136"><img loading="lazy" decoding="async" class="aligncenter wp-image-193136" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_281/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-1024x288.png" alt="cftr assay panel comparison" width="1000" height="281" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-1024x288.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-300x84.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-768x216.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-1536x432.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable1-2048x576.png 2048w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p><strong>Table 2.</strong> Manufacturer-reported <em>CFTR</em> mutation detection rates of a commonly used <em>CFTR</em> targeted panel<sup>5</sup>. Reported coverage percentages are based on data published in 2004 or earlier, meaning coverage could be poorer if compared with more recently published, diverse datasets.</p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2.png" rel="attachment wp-att-193137"><img loading="lazy" decoding="async" class="aligncenter wp-image-193137" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_128/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-1024x131.png" alt="cftr percentages by ethnicity" width="1000" height="128" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-1024x131.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-300x38.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-768x98.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-1536x196.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable2-2048x262.png 2048w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p> </p> <p>However, universal carrier screening is recommended for cystic fibrosis, which means clinicians need results that accurately represent the risk of passing on this disease for patients of all ancestries.<br /> Large-scale population studies are adding rapidly to the information available about pathogenic variants associated with cystic fibrosis in people of diverse genetic backgrounds. Some of these studies deliberately gather data from diverse populations, such as that of the United States<sup>3,4</sup>. The rush of new, publicly-available genomic data represents significant progress in identifying relevant variants across ancestries.</p> <p>Still, this information must be incorporated into carrier screening tests to make a difference for prospective parents wondering if their children would be at risk of inheriting cystic fibrosis. Clinicians ordering carrier screening tests for cystic fibrosis should reach out to their clinical lab teams to ensure that such tests have been recently updated to reflect more diverse data sources — covering not only the most common variants found in the historical database but also diverse population-specific variants identified in large-scale sequencing studies.</p> <p> </p> </div> <div id="non-us-3" class="solutions-detail-content"> <h3 class="solution-subtitle">Spinal Muscular Atrophy (SMA) Carrier Screening</h3> <p>Until recently, a diagnosis of spinal muscular atrophy (SMA) was considered a death sentence. This debilitating neuromuscular disease is a leading genetic cause of death among infants. The introduction of game-changing therapies in the last few years, though, has brought new hope to families of affected individuals<sup>16</sup>.</p> <p>Though these therapies have been revolutionary, they do not negate the need for carrier screening. In fact, SMA carrier screening is recommended by the American College of Obstetricians and Gynecologists (ACOG) and ACMG for all women who are pregnant or planning to become pregnant<sup>1,17</sup>. SMA has a high carrier rate of approximately 1 in 50 individuals<sup>18</sup>.<a href="https://asuragen.com/?attachment_id=193138" rel="attachment wp-att-193138"><img loading="lazy" decoding="async" class="alignright size-medium wp-image-193138" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300,h_300/https://asuragen.com/wp-content/uploads/2022/02/orangecallout-300x300.png" alt="if measuring smn1 copy number alone, silent carrier genotypes can lead to up to 30% false negative results" width="300" height="300" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/orangecallout-300x300.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_150/https://asuragen.com/wp-content/uploads/2022/02/orangecallout-150x150.png 150w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/orangecallout-768x768.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_900/https://asuragen.com/wp-content/uploads/2022/02/orangecallout.png 900w" sizes="auto, (max-width: 300px) 100vw, 300px" /></a></p> <p>In addition, SMA screening accuracy can vary depending on ancestry. Historically, <em>SMN1</em> copy number was thought to be the only information needed for SMA carrier status: if a person had two copies of <em>SMN1</em> it was assumed they were on different alleles and the person could not pass on the disease to a child. Now it is known that conventional tests that report only <em>SMN1</em> copy number may miss “silent carriers”, or people who carry two copies of the <em>SMN1</em> gene on a single allele and no copies on the other allele (Figure 2). This silent carrier genotype can occur in any ethnicity, but it is more common among people of African ancestry<sup>9</sup>, so standard SMA screening tests may be more likely to miss carriers in this population. In fact, if reporting <em>SMN1</em> copy number alone, “silent carrier” genotypes can lead to approximately 30% false negative results for African American patients<sup>9</sup>.</p> <p> </p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart.png" rel="attachment wp-att-193139"><img loading="lazy" decoding="async" class="aligncenter wp-image-193139" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_401/https://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart.png" alt="smn1 false negatives chart" width="1000" height="401" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1086/https://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart.png 1086w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart-300x120.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart-1024x411.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/FalseNegativeChart-768x308.png 768w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p><strong>Figure 2.</strong> Illustration of <em>SMN1</em> “silent carrier” genotype with two <em>SMN1</em> copies on the same allele (center), which can allow for passing on a zero copy allele, compared to a noncarrier genotype where one <em>SMN1</em> copy is present on each allele (right). One copy <em>SMN1</em> carrier genotype is on left. If receiving <em>SMN1</em> copy number results only, silent carriers cannot be distinguished since both center and right genotypes would yield results of 2 copies of <em>SMN1</em>.</p> <p> </p> <p>Fortunately, it has been observed that certain variants (called “linked variants”) in the <em>SMN1</em> gene can help predict silent carrier status. Presence of these variants can help further stratify carrier risk in all ethnicities, and even diagnose carrier status in a few<sup>19, 20</sup> (Table 3).</p> <p> </p> <p><strong>Table 3.</strong> Impact of positive results for an <em>SMN1</em> linked variant (c.*3+80T>G) on SMA carrier risk<sup>19, 20</sup> when positive for two <em>SMN1</em> copies, by ethnicity.</p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3.png" rel="attachment wp-att-193140"><img loading="lazy" decoding="async" class="aligncenter wp-image-193140" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_288/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3.png" alt="smn1 copy number and carrier frequency chart" width="1000" height="288" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2066/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3.png 2066w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3-300x86.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3-1024x295.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3-768x221.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3-1536x442.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable3-2048x590.png 2048w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p>It is no longer enough to report only <em>SMN1</em> copy number for carrier screening. All SMA carrier screening tests should also include detection of these linked variants to provide patients with better information on potential carrier status.</p> <p>Furthermore, many commonly used tests for SMA are not as accurate or as sensitive as they should be when providing such vital clinical information. The test considered the gold standard for SMA testing is based on a cumbersome, time-consuming technology called MLPA. There has been some concern cited that this technology many not reliably distinguish certain copy numbers<sup>21</sup>. In addition, popular SMA screening technologies may not provide linked variant detection to inform carrier risk. Clinicians should check with their clinical lab teams to ensure they are using an SMA carrier screening test capable of providing this information.</p> <p> </p> </div> <div id="non-us-4" class="solutions-detail-content"> <h3 class="solution-subtitle">Fragile X Carrier Screening</h3> <p>Fragile X syndrome is the most common inherited form of intellectual disability and autism, affecting approximately 1 in 4,000 males and 1 in 5,000 females in the United States<sup>22</sup>. ACOG and ACMG recommend carrier screening for this syndrome<sup>1,17,23</sup>. However, of the estimated 1 million women believed to be Fragile X carriers in the U.S.<sup>22</sup>, the majority may be unaware of their carrier status.</p> <p>Fragile X syndrome is caused by a CGG repeat expansion in the <em>FMR1</em> gene on the X chromosome. Different counts of the repeat have different phenotypic outcomes (Table 4). Healthy individuals typically have fewer than 45 CGG repeats, while those who may be unaffected carriers or have associated disorders such as Fragile X-Associated Primary Ovarian Insufficiency (FXPOI) generally have between 55 and 200 repeats. Individuals with at least 200 repeats are diagnosed with Fragile X syndrome.</p> <p> </p> <p><strong>Table 4.</strong> Clinical categories and carrier status of mutations in the <em>FMR1</em> gene<sup>24,25,26</sup>.</p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4.png" rel="attachment wp-att-193141"><img loading="lazy" decoding="async" class="aligncenter wp-image-193141" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_675/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4.png" alt="fmr1 cgg repeats and clinical status, features and carrier status" width="1000" height="675" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2063/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4.png 2063w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4-300x202.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4-1024x691.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4-768x518.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4-1536x1036.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2022/02/CFTREducGuideTable4-2048x1382.png 2048w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p><em>Abbreviations: FXS, fragile X syndrome; FXTAS, fragile X-associated tremor/ataxia syndrome; FXPOI, fragile X-associated primary ovarian insufficiency.</em></p> <p>For any genetic testing platform, obtaining an accurate count of so many repeated DNA triplets is a serious challenge. Additionally, many analysis platforms cannot accurately interrogate the region due to the technical challenges of assessing GC-rich DNA content. Therefore, it is important that fragile X carrier screening is being performed with robust technology that can analyze extreme GC content and provide accurate counts of CGG repeats in order to identify women at risk of having a child with fragile X.</p> <p> </p> <p><a href="http://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB.png" rel="attachment wp-att-193142"><img loading="lazy" decoding="async" class="aligncenter wp-image-193142" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1000,h_489/https://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB.png" alt="number of cgg repeats and risk of expansion to full mutation" width="1000" height="489" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1328/https://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB.png 1328w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB-300x147.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB-1024x501.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2022/02/AGGinterruptGraphRGB-768x376.png 768w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></a></p> <p><strong>Figure 3.</strong> AGG interruption quantification stratifies risk of expansion to full mutation in the next generation<sup>10,11,27</sup>. Risk by CGG repeat number only represented by blue line; 0 AGG interruptions detected, orange line; 1 AGG interruption detected, black line; 2 AGG interruptions detected, teal line. A 70 CGG patient example is illustrated where 21% risk is reported with CGG repeat-only information, which can be further stratified to range from 50% risk when 0 AGG interruptions (orange arrow) are detected to near 0% risk when 2 AGG interruptions are detected (teal arrow).</p> <p>Beyond CGG repeat counts, clinicians should also be provided information on AGG interruptions for women with 50 – 90 CGG repeats. In this select group, the number of AGG interruptions stratifies risk of expansion to a full mutation in offspring beyond that provided by CGG repeats alone (Figure 3). For example, for a woman with a 70 CGG repeat allele, risk of expansion to a full mutation can range from ~0% to 50% depending on the number of AGG interruptions. Information provided by the AGG interruption status can greatly affect reproductive decisions; thus, clinicians should work with their clinical lab partners to ensure they are providing this information for select patients.</p> </div> <div id="non-us-5" class="solutions-detail-content"> <h3 class="solution-subtitle">Conclusion</h3> <p>As insight into inherited diseases grows and diagnostic technology advances, providing all patients with accurate and relevant information must remain the central goal. Thankfully, due to the diligence of many scientists and clinicians, better tests have been developed for cystic fibrosis, spinal muscular atrophy, and fragile X carrier screening. As guidelines have shifted to pan-ethnic carrier screening, it is vital that clinicians and their clinical lab partners are aware of disparities and gaps in genetic information from often-used, yet outdated tests, and that they strive to provide more comprehensive and reliable information for all patients.</p> </div> <div id="non-us-6" class="solutions-detail-content"> <h3 class="solution-subtitle">References</h3> <p>1. Gregg AR, et al. Genet Med. 2021 Oct;23(10):1793-1806.<br /> 2. <span class="ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak" dir="ltr">Sosnay et al Nat Genet. 2013 Oct; 45(10): 1160–1167</span><br /> 3. Beauchamp KA, et al. Genet Med. 2019; 21(11): 2569–2576.<br /> 4. Westemeyer M, et al. Genet Med. 2020 Aug;22(8):1320-1328.<br /> 5. Luminex xTAG® Cystic Fibrosis (<em>CFTR</em>) 60 kit v2 product brochure.<br /> 6. McGarry ME, et al. Pediatr Pulmonol. 2019 Nov;54 (Suppl 3):S74-S83.<br /> 7. Watts KD, et al. J Genet Couns. 2012 Oct;21(5):671-5. doi: 10.1007/s10897-012-9481-2.<br /> 8. Neemuchwala F, et al. Case Rep Pediat. 2018 Jul 2;2018:7217326.<br /> 9. Hendrickson BC, et al. J Med Genet. 2009 Sep;46(9):641-4.<br /> 10. Nolin SL, et al. Genet Med. 2015 May;17(5):358-64.<br /> 11. Nolan SL, et al. Am J Med Genet A. 2013 Apr;161A(4):771-8.<br /> 12. Need AC and Goldstein DB. Trends Genet. 2009 Nov;25(11):489-94.<br /> 13. Mills MC and Rahal C. GWAS Diversity Monitor. 2021. <a href="https://gwasdiversitymonitor.com/" target="_blank" rel="noopener">https://gwasdiversitymonitor.com/</a><br /> 14. Veit G, et al. Mol Biol Cell. 2016 Feb 1; 27(3): 424–433.<br /> 15. Watson MS, et al. Genet Med. Sep-Oct 2004;6(5):387-91.<br /> 16. Nance JR. Spinal Muscular Atrophy. Continuum (Minneap Minn). 2020 Oct;26(5):1348-1368.<br /> 17. Rink B, et al. ACOG Opinion No 691. March 2017. Reaffirmed 2020.<br /> 18. Cure SMA. 2021. <a href="https://www.curesma.org/carriers-of-sma/" target="_blank" rel="noopener">https://www.curesma.org/carriers-of-sma/</a><br /> 19. Luo, et al. Genet Med. 2014 Feb;16(2):149-56.<br /> 20. Alías L, et al. Eur J Hum Genet. 2018 Oct;26(10):1554-1557.<br /> 21. Schorling DC, et al. Neurology. 2019 Aug 6;93(6):267-269.<br /> 22. National Fragile X Foundation. 2021. <a href="https://fragilex.org/" target="_blank" rel="noopener">https://fragilex.org/</a><br /> 23. Sherman S, et al. Genet Med. 2005 Oct;7(8):584-7.<br /> 24. Online Mendelian Inheritance in Man, OMIM®. Johns Hopkins University, Baltimore, MD. MIM Number: 300623. 2019. <a href="https://omim.org/" target="_blank" rel="noopener">https://omim.org/</a><br /> 25. Online Mendelian Inheritance in Man, OMIM®. Johns Hopkins University, Baltimore, MD. MIM Number: 300624. 2019. <a href="https://omim.org/" target="_blank" rel="noopener">https://omim.org/</a><br /> 26. Allen EG, et al. Genet Med. 2021 Sep;23(9):1648-1655.<br /> 27. Villate O, et al. Front Mol Biosci. 2020 Jul 14;7:135.</p> </div> </div> </div> </div> <div class="sidebar"> <div class="solutions-toggle"> <a href="#p-solutions-detail-option" class="popupToggle">Change Location</a> </div> <div class="popup" id="p-solutions-detail-option"> <div class="popup-background"></div> <div class="info"> <a class="close"><svg viewbox="0 0 40 40"><path d="M 10,10 L 30,30 M 30,10 L 10,30"/></svg></a> <div class="text"> <div class="solutions-detail-popup"> <div class="map"> <svg xmlns="http://www.w3.org/2000/svg" viewbox="0 0 1009 651" xmlns:xlink="http://www.w3.org/1999/xlink" version="1.1"> <g class="north-america continent" data-target="north-america"> <path id="US" title="United States" class="land" 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