NEW YORK (GenomeWeb) – Seattle-based Resolution Biosciences announced today that New York State's Clinical Laboratory Evaluation Program (NY CLEP) has granted regulatory approval for the company's ctDx Lung cancer assay, a targeted next-generation sequencing test that identifies actionable mutations in blood samples from non-small cell lung cancer patients.
President and CEO Mark Li said in a statement that the certification will allow Resolution to reach more patients, as well as ease the way for ongoing and planned clinical studies in New York.
The firm's ctDx assay was designed to detect not just single nucleotide variants but also more difficult—to-detect alterations like insertions and deletions, copy number variation, and gene fusions. The test is focused on a small panel of genes with known relevance in guiding the use of targeted therapies and determining patient eligibility for clinical trials.