After nearly five long years of raising cash and completing additional clinical trials needed to win limited coverage, Integrated Diagnostics Inc. (Indi) said it will be the first company to introduce a liquid biopsy molecular diagnostic test for lung cancer in the US.
Indi's CEO Al Luderer said the company's second-generation Xpresys Lung (XL2) CLIA laboratory test is designed to help pulmonologists in the challenging task of identifying lung nodules that have a high probability of being benign; and thus,
"It has taken us $80m to get to this point and we still have a long way to go," Luderer told Medtech Insight. Indi launched the first-generation Xpresys Lung test in 2013. But when CMS denied coverage for that test, asking for more clinical data, Luderer quickly responded by pulling back the sales force, making the company small and shifting the focus toward completing clinical trials