NEW YORK (GenomeWeb) — Inivata announced today it has received a draft Medicare local coverage determination (LCD) through MolDx for its blood-based InVisionFirst-Lung test, a targeted sequencing assay that detects mutations in the blood of non-small cell lung cancer patients to inform treatment selection.
In the draft LCD, Medicare administrative contractor Palmetto GBA has recommended coverage for InVisionFirst-Lung, Inivata said. The draft will go through a public comment period before being finalized and implemented.
"The use of liquid biopsy can help guide physicians in treating their patients with the most effective therapies, especially in those patients who may have insufficient tumour tissue available for full genomic analysis or who are unsuitable for such invasive tissue biopsy procedures due to the risks involved," Inivata CEO Clive Morris said in a statement.
Earlier this year, Inivata published the results of an analytical validation of InVisionFirst-Lung showing that the test can pick up mutations at low frequencies, with high specificity, and with high concordance to results using digital PCR assays.
Inivata said that its LCD submission included data from a large-scale prospective clinical validation study of InVisionFirst-Lung that are slated for presentation later this year at the International Association for the Study of Lung Cancer World Conference on Lung Cancer.