NEW YORK (GenomeWeb) – Guardant Health today announced the Guardant360 assay has been approved by New York State's Clinical Laboratory Evaluation Program.
The assay is the first liquid biopsy permitted by the program, which Guardant said is one of the most demanding lab certification programs in the country, and the approval means Guardant360 can be offered in all 50 states.
The blood-based 73-gene test investigates actionable somatic alteration across all solid tumor sites to provide clinicians information to better manage their patients' disease, according to Guardant. Last week, Medicare contractor Palmetto GBA released a draft local coverage determination for the test, proposing limited coverage for it in patients with advanced non-small cell lung cancer.
The test was launched in 2014 and has been ordered more than 40,000 times by more than 3,500 oncologists since, Guardant said.