Inivata, a leader in liquid biopsy, has announced that Palmetto GBA, a Medicare Administrative Contractor recognized for its molecular diagnostic technology assessment experience through its assessment group, MolDx, has issued its final Coverage Determination for InVisionFirst™-Lung Liquid Biopsy test, a blood-based circulating tumor DNA (ctDNA) test for the detection of genomic alterations in the most commonly mutated genes in advanced Non-Small Cell Lung Cancer (NSCLC).

This policy, which becomes effective April 8, 2019, provides specific coverage for InVisionFirst-Lung for all fee-for-service Medicare patients in the United States with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.

Clive Morris, Chief Executive Officer at Inivata, said: “This is a major milestone for Inivata and an important step for the many patients with advanced Non-Small Cell Lung Cancer for whom tissue-based genomic profiling is not possible. Using a simple blood draw, InVisionFirst-Lung provides clinicians with the genomic information needed to inform patient management, which may help in the identification of effective therapies when the patient is first diagnosed or as the disease progresses.”

Approximately 222,500 new cases of lung cancer will be diagnosed in the US during 2019 with 80% to 85% being NSCLC. The disease is by far the leading cause of cancer death among both men and women. Using traditional tissue biopsies to diagnose and analyze the disease involves a highly invasive procedure which carries significant risks and is expensive. Obtaining sufficient tissue to allow physicians to fully characterize all the markers required for current FDA approved therapeutics is often difficult and as a consequence only a minority of patients receive the tumor characterization/profiling recommended in professional guidelines. A liquid biopsy, which uses a simple blood test, allows powerful genetic analysis to be carried out at lower-cost than traditional tissue biopsy and for results to be available more quickly, which can be critical when treatment decisions are being made and tissue is not available or insufficient.

The coverage recommendation was based on data including those from a large-scale prospective clinical validation study led by Dr Ramaswamy Govindan, Professor of Medicine, at the Washington University School of Medicine. This study showed InVisionFirst-Lung had excellent concordance with standard of care tissue profiling, enabled more complete profiling of patients with advanced NSCLC and revealed 26% more actionable mutations than standard of care tissue testing. The data were presented at the World Conference on Lung Cancer on September 24, 2018. The full data set has been accepted for publication in a leading peer-reviewed journal.

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