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Inivata Medicare Local Coverage Decision Finalized for InVisionFirst-Lung Liquid Biopsy

NEW YORK (GenomeWeb) – Inivata said today that Medicare administrative contractor Palmetto GBA has finalized its draft local coverage determination (LCD) for the company's liquid biopsy lung cancer test, InVisionFirst-Lung.

The policy, which becomes effective April 8, provides specific coverage for the test for all fee-for-service Medicare patients in the US with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.

More specifically, the LCD provides for limited coverage of InvisionFirst- Lung for patients in three cases. First, at diagnosis, when genotyping results for EGFR, ALK, ROS1, and BRAF variants are not already available and when tissue-based comprehensive genetic profiling, or CGP, is deemed infeasible.

Second, for patients progressing on or after chemotherapy or immunotherapy who have never been tested for the same list of biomarkers, and for whom tissue-based CGP is infeasible. Or third, for patients progressing on EGFR tyrosine kinase inhibitors.

In the draft LCD Palmetto specified that this would exclude the EGFR TKI osimertinib, but wrote in response to comments to the draft that the finalized determination would reverse that distinction, making the test covered for patients progressing on any drug in this class.

The determination also states that physicians should consider tissue genotyping if no genetic alteration is detected by the InVision test.

Inivata said that CMS's evaluation was supported by data, including results from a large-scale prospective clinical validation study led by researchers at the Washington University School of Medicine, which showed that the liquid biopsy test had high concordance with standard of care tissue profiling, enabled more complete profiling of patients, and detected 26 percent more actionable mutations than tissue analysis.