Colvera™ is a clinically validated blood test that is designed to help detect colorectal cancer (CRC) recurrence by measuring fragments of genetic material, circulating tumor DNA (ctDNA), that leak from a tumor into the blood stream. With Colvera, it may be possible to identify CRC recurrence in advance of symptoms before other tests indicate recurrence.
Multiple peer-reviewed manuscripts establishing the analytical and clinical validity of Colvera have been published in scientific journals. Recent clinical trial data show that Colvera is more than 2 times as sensitive for CRC recurrence than carcinoembryonic antigen (CEA), the only guidelines-recommended blood test for the detection of recurrent CRC. These data demonstrate that Colvera presents a new opportunity for oncologists to potentially improve treatment regimens through better, earlier disease detection that may lead to improved patient survival.
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Colvera is a PCR-based test measuring two epigenetically modified genes, hyper-methylated BCAT1 and IKZF1, in free circulating DNA which may leak from cancerous lesions into the bloodstream. This product is the result of almost a decade of research, development and clinical validation studies, including testing in more than 4,000 volunteers.
Colvera was developed in partnership between Clinical Genomics, Flinders University and the Commonwealth Scientific and Industrial Research Organisation (CSIRO), the national federal government agency for scientific research in Australia.
Colvera is a laboratory-developed test and its performance characteristics have been determined by Clinical Genomics. These statements have not been reviewed by the U.S. Food and Drug Administration. Clinical Genomics Pathology Inc. is regulated under CLIA as qualified to perform high-complexity testing.