NEW YORK – Oncocyte announced Thursday its DetermaRx molecular diagnostic test for non-small cell lung cancer (NSCLC) received coverage from Medicare Administrative Contractor Palmetto GBA.
The general coverage determination issued by Palmetto covers the use of molecular diagnostic tests as predictive classifiers for NSCLC and are considered reasonable and necessary for patients with non-squamous NSCLC with a tumor smaller than 5 centimeters and no positive lymph nodes. The patient must also be healthy enough to tolerate chemotherapy and be under consideration for adjuvant platinum-containing chemotherapy. The test must be ordered by a physician treating the patient for NSCLC to help decide whether to recommend adjuvant chemotherapy.
The coverage determination is effective for services performed on or after June 14.
Oncocyte's PCR test can predict which high-risk NSCLC patients are likely to respond to adjuvant chemotherapy after surgical resection, the company said. It is designed to be used on formalin-fixed, paraffin embedded lung cancer tissue and interprets data from 11 target genes and three reference genes.
The test was previously known as the Razor treatment stratification test and was being developed by Razor Genomics, which Oncocyte acquired last year. Razor received a draft local coverage determination from Palmetto last August. The test was commercially launched at two early-access sites in January and has expanded to 20 sites, Oncocyte said in a statement.
"Not only can we now increase outreach to more patients and physicians around the country, but we believe several national and regional payers will follow this decision, giving additional patients insurance coverage for this important test,” said Ron Andrews, CEO of Oncocyte.
The company added that now that it has received Medicare coverage it intends to intensify its efforts to get the test covered by private insurers.