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Clinical Genomics Licensed in California

NEW YORK (GenomeWeb) — Clinical Genomics said today that its CLIA-licensed and CAP-accredited New Jersey laboratory has received licensure from California authorities to offer the Colvera colorectal cancer test to residents of the state.

Colvera is a PCR-based test for colorectal cancer recurrence monitoring. It measures methylation in circulating tumor DNA in a peripheral blood sample and can indicate the presence or absence of two altered genes associated with colorectal cancer.

"This approval allows California physicians to offer Colvera to their patients in one of the largest oncology markets in the US and now the [fifth] largest economy in the world," Clinical Genomics President and CEO Lawrence LaPointe said in a statement.

Since launching Colvera in late 2016, Clinical Genomics has been focused on expanding the test's availability in the US. With the license from the State of California Department of Public Health, Colvera is available in all US states except New York. A company spokesperson said that the company is actively pursuing New York licensure.

Clinical Genomics — which closed a $26 million financing round earlier this month — is also evaluating Colvera's use in rectal cancer monitoring.