Draft Medicare local coverage determination for InVisionFirstTM-Lung liquid biopsy test

Inivata, a Cambridge Innovation Capital plc (CIC) portfolio company, has announced that it has received a draft local coverage determination (LCD) for Inivata’s InVisionFirst-Lung test. The draft LCD recommends coverage for InVisionFirst-Lung to aid clinicians in treatment decisions relating to advanced Non-Small Cell Lung Cancer (NSCLC).

Inivata is a leader in liquid biopsy which, using a simple blood test, allows powerful genetic analysis to be carried out at lower-cost than traditional tissue biopsy.  In addition, results can be available more quickly, which can be critical when treatment decisions are being made. Approximately 222,500 new cases of lung cancer will be diagnosed in the US during 2018 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 analyse the disease involves a highly invasive procedure which carries significant risks and is expensive. Obtaining sufficient tissue to allow physicians to fully characterise all the markers required for current FDA approved therapeutics is often difficult and, as a consequence only a minority of patients receive the tumour characterisation and profiling recommended in professional guidelines.

Clive Morris, Chief Executive Officer at Inivata, said, “This milestone is a significant step for Inivata, for clinicians and for patients with advanced NSCLC. The use of liquid biopsy can help to 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.”

Robert Tansley, Operating Partner at CIC, said, “The use of liquid biopsy brings substantial benefits in the management of cancer. Inivata is at the forefront of this revolution in diagnosis and management. The InVision liquid biopsy platform is a powerful tool in aiding physicians to make treatment decisions for lung cancer patients. CIC welcomes this news which emphasises Inivata’s leading position in this important field. We are delighted to have supported Inivata since the time of its seed funding.”

The draft LCD will go through a public comment period before being finalised and implemented.