NEW YORK (GenomeWeb) – Biodesix on Monday said that it has received New York State Clinical Laboratory Evaluation Program (CLEP) approval for its GeneStrat lung cancer liquid biopsy test.
GeneStrat is a blood-based test using a droplet digital PCR platform that detects mutations relevant to patient treatment in non-small cell lung cancer. The current version tests for EGFR sensitizing; EGFR resistance (T790M), KRAS, and BRAF mutations; and EML4-ALK, ROS1 and RET fusion variants.
Biodesix launched the test in 2015 and has positioned it as a rapid-turnaround test aimed at the community setting, with results available within 72 hours, according to the company.
The company offers the test out of its Boulder, Colorado-based laboratory, which in addition to receiving CLEP approval has been certified by CAP, CLIA, and ISO 35485.