CAMBRIDGE, England--(BUSINESS WIRE)--

Lab21, the global specialist in personalized medicine and clinical diagnostics, is pleased to announce that routine analysis of clinical samples has begun from Lab21 Inc.s new CLIA laboratory in Greenville, South Carolina.

The first assays in the test menu include a new Human Papillomavirus (HPV) High Risk and HPV 16 and 18 Genotyping Service. Using the Roche COBAS 4800 HPV Genotyping test, Lab21 can identify high risk patients and differentiate those patients with HPV 16 and HPV 18 Genotypes. The Lab21 service launches concurrently with new guidelines for the prevention and early detection of cervical cancer which were recently issued by the American Cancer Society (ACS), the American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP).

Michael Bolick, President, Lab21 Inc said Over recent months we have grown the Greenville team and worked closely with local clinicians to prioritize the menu of tests required by local hospitals. The final validation of these assays and the receipt of our first patient samples are the culmination of Lab21s strong team work internationally. Our colleagues from the UK have developed best practices in molecular diagnostic testing that we have transferred, along with key individuals, into our US operations.

Lab21 Inc is focused on the provision of molecular diagnostic testing services in oncology and infectious disease. Launch of these services will include KRAS, EGFR and BRAF mutation analysis, HIV viral resistance and tropism and viral load assays. This follows Lab21s recent launch of the Clinical Genomics Center at ITOR, a hospital based cancer research organization located in Greenville, South Carolina. It is planned that through the partnership with ITOR, Lab21 will develop new companion diagnostic assays required to accompany new drug therapies.

Ken Morgan, Vice President Operations, Lab21 Inc said We welcome our new Laboratory Manager, Susan Foster, and Clinical Sequencing Group Leader, Jeremy Stuart to Lab21 Inc who are two very experienced clinical testing professionals from market leading companies. During the next 12 months we intend to grow our core team in Greenville rapidly as we add new test menu and launch our own companion diagnostic assays.

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About Lab21

Lab21 is a global leader in personalized healthcare. It provides diagnostic products and services and supports blood bank screening, medical diagnostics and drug discovery. Lab21 customers include international healthcare providers, pharmaceutical and diagnostic companies. The Products division of Lab21 manufactures immunodiagnostic kits and reagents that are distributed internationally and is focused on infectious diseases for the blood-banking and clinical markets. Our clinical services operations have a growing test portfolio providing companion diagnostics and high technology molecular assays. Lab21's corporate offices are based in Cambridge, UK and Greenville, South Carolina, with a GMP manufacturing site in Cambridge and other manufacturing facilities in Newmarket, Camberley, Manchester and Bridport. Website: http://www.lab21.com

About the new guidelines for the prevention and early detection of cervical cancer

Link:

Lab21 Unveils New Molecular Analysis Services at Greenville Site