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FOLR1 Ovarian Cancer Testing Program | NeoGenomics Laboratories

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id="layout-hero"> <div class="hero-wrap"> <div class="hero-content"> <div class="region region-hero"> <div class="views-element-container block block-views block-views-blockgroup-header-block-1" id="block-views-block-group-header-block-1"> <div><div class="view view-group-header view-id-group_header view-display-id-block_1 js-view-dom-id-cb41f4e0bbd03c54a1232294f5ff9545553eb7079f67ea21c1fae5d6a1d54ba3"> <div class="view-content"> <div class="views-row"><div class="views-field views-field-field-media-image-3-1"><div class="field-content"><div class="node-header large"> <div class="node-header-image" data-node-header-image="/sites/default/files/hero-image/AdobeStock_525564248_Preview.jpg"> <div class="node-header-tab"></div> <div class="node-header-content"> <div class="node-header-wrap"> <h1 class="large">FOLR1 Ovarian Cancer Testing Program</h1> <h4 class="page-subtitle"></h4> </div> </div> </div> </div></div></div></div> </div> </div> </div> </div> <div class="views-element-container block block-views block-views-blockdefault-header-block-1" id="block-views-block-default-header-block-1"> <div><div class="view view-default-header view-id-default_header view-display-id-block_1 js-view-dom-id-5967131ddd8f2f1a2df985802ff683d490673f3e54f1280fef2a4b95f6eeff75"> </div> </div> </div> </div> </div> </div> </div> <div id="layout-above-content"> <div class="wrap-above-content"> <div class="above-content-content"> <div class="region region-above-content"> <div id="block-neogenomics-breadcrumbs" class="block block-system block-system-breadcrumb-block"> <nav class="breadcrumb" role="navigation" aria-labelledby="system-breadcrumb"> <h2 id="system-breadcrumb" class="visually-hidden">Breadcrumb</h2> <ol> <li> <a href="/">Home</a> </li> <li> <a href="/diagnostic-services">Diagnostic Services</a> </li> <li> <a href="/diagnostic-services/sponsored-testing-programs">Sponsored Testing Programs</a> </li> <li> FOLR1 Ovarian Cancer Testing Program</li> </ol> </nav> </div> </div> </div> </div> </div> <main role="main" class="layout-main"> <div class="wrap-main"> <div class="main-content"> <section class="no-sidebar content-wrap"> <div class="layout-content"> <a id="main-content" tabindex="-1"></a> <div class="region region-content"> <div data-drupal-messages-fallback class="hidden"></div> <div id="block-neogenomics-content" class="block block-system block-system-main-block"> <article data-history-node-id="1539" class="node node--type-promo node--view-mode-full"> <div class="node__content"> <div class="field field--name-field-section field--type-entity-reference-revisions field--label-hidden field__items"> <div class="paragraph paragraph--type--columns paragraph--view-mode--default corporate-pattern-bg"> <div id="" class="col-half padding-top-bottom-100"> <div class="field field--name-field-column-content field--type-entity-reference-revisions field--label-hidden field__items"> <div class="field__item"> <div class="paragraph paragraph--type--wysiwyg paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p class="large">Folate Receptor alpha (FRα): an actionable therapeutic target in platinum-resistant ovarian cancer</p> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--wysiwyg paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>NeoGenomics is pleased to partner with ImmunoGen on a FOLR1 sponsored testing initiative called FR-ASSIST<sup>™</sup>, helping reduce barriers to immunohistochemistry (IHC) testing for novel biomarkers and aiding oncologists to make informed treatment decisions for their ovarian cancer patients.</p> <p>FRα is an actionable target with the approval of ELAHERE<sup>™</sup> (mirvetuximab soravtansine-gynx), a FDA-approved FRα—targeting antibody drug conjugate (ADC) for platinum-resistant ovarian cancer. It is important to test all ovarian cancer patients for FRα expression.</p> <p>The FRα protein is expressed in 90% of ovarian cancers and has limited expression in normal tissue, making it an attractive therapeutic target. When using the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay for the evaluation of ovarian cancer patients, approximately 35% of patients are considered to have high expression of FRα— defined as ≥75% tumor cells staining at 2+/3+ intensity— and thus eligible for treatment with ELAHERE.</p> </div> </div> </div> </div> </div> </div> <div id="" class="paragraph paragraph--type--text-image-equal-height-columns paragraph--view-mode--default"> <div class="equal-height-image-section img-right_mobile_top"> <div class="equal-height-image-content"> <div id="paragraph-id-1359" class="media-wrap lazyload-bg" style=";background-image: url('/sites/default/files/styles/lazy_load/public/2022-11/GettyImages-481073822.jpg?itok=kDir6ZgJ');" data-lazyload="/sites/default/files/2022-11/GettyImages-481073822.jpg"></div> <div class="content-wrap" style=""> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><h2>FR-ASSIST<sup>™</sup> FOLR1 Ovarian Cancer IHC Testing Program</h2> <p>To support physicians in determining FRα expression in their ovarian cancer patients, ImmunoGen is providing a sponsored, no-charge, third-party IHC testing program for patients with a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer.</p> <h3>Patient Eligibility Criteria:</h3> <p>Eligible patients may receive one (1) FOLR1 FDA (ELAHERE™) for Ovarian Carcinoma test at no cost regardless of test results or treatment decision. Patients must meet all of the following criteria to be eligible:</p> <ul> <li>Patient has ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer or primary fallopian tube cancer)</li> <li>Patient lives and receives treatment in the United States or a US Territory</li> <li>Patient does not have a known FRα expression from a previous test</li> <li>Patient has not previously been tested under this Program</li> </ul> <p>Please note the program does not cover any other costs, including, but not limited to, office fees and biopsy fees. FOLR1&nbsp;will be made available broadly to prescribers without regard to prescribing volumes or other commercial considerations.</p> <p>To enroll your patient in the FOLR1 IHC Testing Program, <a href="/sites/default/files/requisitions/FOLR1-IHC-CDx-Sponsored-Testing-Program-Request-Form_071223_Final_FF.pdf" target="_blank">download the FOLR1 test request form</a>.&nbsp;<br>&nbsp;</p> </div> </div> </div> </div> </div> <div class="paragraph paragraph--type--resources paragraph--view-mode--default"> <h4 class="resources-title">Resources</h4> <div class="field field--name-field-links field--type-link field--label-hidden field__items"> <div class="field__item"> <a href="/sites/default/files/requisitions/FOLR1-IHC-CDx-Sponsored-Testing-Program-Request-Form_071223_Final_FF.pdf" tabindex="0" target="_blank"> FOLR1 Test Request Form </a> </div> <div class="field__item"> <a href="/test-menu/folr1-fda-elaheretm-ovarian-carcinoma" tabindex="0" > FOLR1 FDA (ELAHERE™) for Ovarian Carcinoma </a> </div> <div class="field__item"> <a href="/sites/default/files/2022-12/SampleReport_FOLR1_Positive_11.21.22.pdf" tabindex="0" target="_blank"> Positive Sample Report </a> </div> <div class="field__item"> <a href="/sites/default/files/2022-12/SampleReport_FOLR1_Negative_11.21.22.pdf" tabindex="0" target="_blank"> Negative Sample Report </a> </div> </div> </div> <div class="paragraph paragraph--type--columns paragraph--view-mode--default"> <div id="" class="col-full padding-top-100"> <div class="field field--name-field-column-content field--type-entity-reference-revisions field--label-hidden field__items"> <div class="field__item"> <div class="paragraph paragraph--type--wysiwyg paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p class="medium">FAQ for Health Care Professionals</p> </div> </div> </div> </div> </div> </div> <div id="" class="paragraph paragraph--type--accordion paragraph--view-mode--default padding-bottom-100"> <div class="field field--name-field-accordion-items field--type-entity-reference-revisions field--label-hidden field__items"> <div class="field__item"> <div class="paragraph paragraph--type--accordion-item paragraph--view-mode--default"> <div class="field field--name-field-title field--type-string field--label-hidden field__item">What role does folate receptor alpha (FRα) play in ovarian cancer?</div> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>Folate receptor alpha (FRα) is an actionable therapeutic target that is commonly expressed in ovarian cancer. Approximately 35% of ovarian cancer patients are expected to be positive for FRα expression by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.</p> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-item paragraph--view-mode--default"> <div class="field field--name-field-title field--type-string field--label-hidden field__item">Why should I test for folate receptor alpha (FRα) in my ovarian cancer cases?</div> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>With the approval of ELAHERE™ (mirvetuximab soravtansine-gynx), FRα is now an actionable target in platinum-resistant ovarian cancer.</p> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-item paragraph--view-mode--default"> <div class="field field--name-field-title field--type-string field--label-hidden field__item">Is this the companion diagnostic test for ELAHERE™ (mirvetuximab soravtansine-gynx)?</div> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>Yes; NeoGenomics is validated to run the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the FDA-approved companion diagnostic for ELAHERE<sup>™</sup>. NeoGenomics provides this test under the name FOLR1 FDA (ELAHERE<sup>™</sup>) for Ovarian Carcinoma.</p> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-item paragraph--view-mode--default"> <div class="field field--name-field-title field--type-string field--label-hidden field__item">Who should get tested for FOLR1 protein expression (also known as FRα)?</div> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is intended for use in the assessment of FRα in ovarian cancer, including epithelial ovarian cancer, primary peritoneal cancer or primary fallopian tube cancer. Because FRα is generally stable through the course of treatment, testing can be done upon diagnosis of ovarian cancer or at progression.</p> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-item paragraph--view-mode--default"> <div class="field field--name-field-title field--type-string field--label-hidden field__item">Can I use archival ovarian cancer tissue for testing?</div> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>Yes; Fresh or archival ovarian cancer tissue is acceptable for FOLR1 IHC CDx testing.</p> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-item paragraph--view-mode--default"> <div class="field field--name-field-title field--type-string field--label-hidden field__item">How do I order the test?</div> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>The ordering health care provider must complete and sign the appropriate FOLR1 IHC CDx Test Request Form and submit it to NeoGenomics, or complete the information and attestation in NeoGenomics’ online ordering system. Completion of this form is required and submission also enrolls the patient in the Companion Diagnostic Testing Program.</p> <p>The Test Request Form is <a href="/sites/default/files/requisitions/FOLR1-IHC-CDx-Sponsored-Testing-Program-Request-Form_071223_Final_FF.pdf" target="_blank">available here</a>. If tests in addition to the FOLR1 IHC CDx are required on the submitted tissue specimen, please also complete a separate standard, printed NeoGenomics test requisition or create a new accession in online ordering.</p> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-item paragraph--view-mode--default"> <div class="field field--name-field-title field--type-string field--label-hidden field__item">What are the specimen requirements for tissue?</div> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>NeoGenomics offers FOLR1 IHC CDx testing on formalin-fixed paraffin-embedded (FFPE) tumor resection or biopsy samples. Ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer and primary fallopian tube cancer) tissue is required. The paraffin block is preferred. Alternatively, send One (1) unbaked, unstained slide for H&amp;E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns). Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives or send decalcified specimens.</p> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-item paragraph--view-mode--default"> <div class="field field--name-field-title field--type-string field--label-hidden field__item">When can I expect the results?</div> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>Results are typically ready in 48 hours from the time the specimen is received at NeoGenomics and will be sent to the ordering physician’s office or laboratory by their preferred method of delivery.</p> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-item paragraph--view-mode--default"> <div class="field field--name-field-title field--type-string field--label-hidden field__item">What if I get a bill?</div> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>No patient, health care program, or beneficiary shall be billed for this test as part of the testing program. If you should receive a bill, please contact the NeoGenomics Billing Department at 866-776-5907, option 2.</p> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--accordion-item paragraph--view-mode--default"> <div class="field field--name-field-title field--type-string field--label-hidden field__item">Who should I contact if I have a question?</div> <div class="clearfix text-formatted field field--name-field-body field--type-text-long field--label-hidden field__item"><p>If you have questions about our testing process, please contact NeoGenomics Client Services at 866.776.5907 or <a href="mailto:client.services@neogenomics.com">client.services@neogenomics.com</a>.</p> <p>Further information about ELAHERE™ and FRα is <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1e5e694b-5ac3-4a74-9d01-f3a53488b2ac" href="https://elaherehcp.com/" target="_blank">available here</a>.</p> </div> </div> </div> </div> </div> <div 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