NEW YORK (GenomeWeb) – OncoCyte said today that its Alameda, California clinical laboratory facility has received a CLIA certification of registration from the Centers for Medicare and Medicaid Services.
Certificates of registration allow labs to conduct moderate or high complexity testing ahead of being inspected for compliance with CLIA regulations, at which point they can receive a certificate of compliance.
In addition to its CLIA registration, OncoCyte said its lab has also now passed inspection by the California Department of Public Health, making it licensed and operational in that state. California is among a handful of states require licensing by their own regulatory bodies, as well as CLIA certification, in order for a lab to receive patient samples from those states.
The company plans to launch and offer its first assay, DetermaVu, from the lab in the fourth quarter of this year, pending results of two planned validation studies. DetermaVu is a noninvasive confirmatory lung cancer diagnostic, which measures a panel of mRNA markers in blood samples to predict which patients with positive lung imaging results have benign versus malignant nodules.