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Cancer Genetics Cervical Cancer Test Gets CLIA OK

NEW YORK (GenomeWeb News) – Cancer Genetics said today its genomic test for triaging cervical cancer patients has received approval in the US as a lab-developed test under Clinical Laboratory Improvement Amendments regulations.

CGI's FHACT test is designed to enable early detection of cervical cancers caused by human papillomavirus and help physicians make decisions about treating patients.

CGI also said it is launching a database called FHACT-NET that will track the test's use and clinical outcomes and will help oncologists, pathologists, and gynecologists gain insights into how the diagnostic is impacting treatment.

The cloud-based, HIPAA-compliant database will compile data from sites where the FHACT is being performed and will create a genomic knowledge base of curated, de-identified data. Participants that are expected to contribute to the network include national and international labs, cancer centers, and hospitals.

Nearly all cases of cervical cancer are caused by oncogenic types of HPV, and there are around 12 high-risk HPV types that are associated with other HPV-related cancers, CGI said. The company said it has launched studies to develop and refine its test for these other HPV types.

The Rutherford, NJ-based firm said the test will be made available under partnerships and collaborations with regional labs, hospitals, and women's health centers.

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