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History </span> </span> </p> </div> </div> </div> </div> <div id="j-content" class="o-wrapper"> <div class="o-grid"> <div class="o-grid__item u-width-full u-p-t4 s-cms">   <h3 class="has-text-align-left wp-block-heading" id="h-almac-diagnostic-services-was-initially-founded-as-a-spin-out-company-from-queen-s-university-belfast-in-2002-called-arradx">Almac Diagnostic Services was initially founded as a spin out company from Queen’s University Belfast in 2002 called ArraDx.</h3> <p>In 2004, ArraDx was incorporated into the Almac Group under the direction of Sir Allen McClay and became Almac Diagnostic Services. It was a vision of the Almac Group to have a Diagnostics division to support the growing need for Diagnostic services and to enable the delivery of precision medicine globally.</p> <p>Since that time, Almac Diagnostic Services has continued to grow and evolve as a business focussed on offering clients a first class service across: <a href="/diagnostics/genomic-services/">Genomic Services</a>, <a href="/diagnostics/clinical-trial-assays/">Clinical Trial Assays</a> and <a href="/diagnostics/companion-diagnostics/">Companion Diagnostics</a>. The management team has remained largely the same, reflecting the knowledge base, experience  & stability of the company.</p> <p>In terms of Regulatory Standards, Almac Diagnostic Services has held CLIA Lab Accreditation since 2011 and CAP Accreditation since 2012. We received our New York State Permit (CLEP) in 2013 and were awarded several other US State permits between 2011 and 2016 including Pennsylvania, California, Maryland and Rhode Island. </p> <p>In terms of Quality ISO certification Almac Diagnostic Services was awarded ISO 17025 in 2005, ISO 13485 in 2015 and ISO 15189 in 2017. In addition, Almac has Certified compliance with ISO 14971 Risk management for medical devices and compliance with IEC 62304 Medical Device Software: Software life-cycle processes.</p> <p>Almac Diagnostic Services expanded laboratory capabilities by setting up a new laboratory in Durham, North Carolina, USA, in 2016. We continue to expand our range of platform options for clients and have strong partnership agreements in place with key providers including Illumina, Thermo Fisher, QIAGEN, nanoString, Archer, BioRad and PGDx.</p> <p>Almac Diagnostic Services growth trajectory aligns with increasing global demand for our offerings. We continue to expand our range of services to Pharma and Biotech clients.</p> <p>We have won several awards along the way for our science and innovation capabilities. Most notably the UKTI Award for Innovation as part of the European Business Awards, the ‘R&D Development Achievement Award’ for our DDRD Assay (now known as the DDIR Signature) as part of the Irish Pharma Industry Awards and finally the ‘Excellence in Technology’ award as part of the Belfast Telegraph Business Awards.</p> <p>Almac Diagnostic Services flexible approach has attracted many successful Companion Diagnostic (CDx) partnerships over the years and we look forward to the future by increasing these partnerships with Pharma and Biotech companies globally.</p> <div style="height:50px" aria-hidden="true" class="wp-block-spacer"></div> </div> </div> </div> </article> </div> <div class="c-diagnostics__updates c-page-footer__updates u-p-y5 u-align-center u-relative"> <a href="#main" class="backToTop backToTop--alt" aria-label="click to scroll to page top"></a> <div class="o-wrapper"> <div class="o-grid"> <div class="o-grid__item u-width-full mailing-list"> <h3 class="u-normal u-m-r3 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