ArcherDx Seeking Broader Reach for Cancer Diagnostic

ArcherDx just got put on the fast track in getting its companion diagnostic on the market. The Boulder, CO-based company said it has been granted a Breakthrough Device Designation for its liquid biopsy and tissue specimen diagnostic application. The Breakthrough Device Designation will allow for an expedited approval pathway and would allow the company to have more frequent interactions with FDA in an effort to get to market faster. Executives from the Boulder, CO-based company found the time to speak about the test with MD+DI on Tuesday, while they were attending the very busy 37th Annual J.P. Morgan Healthcare Conference. Are you ready for MD&M West? Join us from Feb. 5 - Feb. 7 for medtech's premiere event in Anaheim, CA.   “This is a companion diagnostic that looks at both tissue and blood, in which we are seeking multiple diagnostic claims for already-approved drugs,” Josh Stahl, Chief Scientific Officer and Executive VP of Diagnostics for ArcherDx, told MD+DI. “We’re also doing prospective trials with pharmaceutical partners.” The Boulder, CO-based company said its diagnostic assay is a sequencing-based test analyzing more than 50 genes intended for detection of somatic alterations in circulating tumor DNA (ctDNA) present in plasma and in RNA or DNA derived from formalin fixed paraffin embedded (FFPE) cancer tissue. Results of the ArcherDX co...
Source: MDDI - Category: Medical Devices Authors: Tags: Testing IVD Source Type: news