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Liquid Biopsy Firm Resolution Bio Gets CLIA Certification for Lab

NEW YORK (GenomeWeb) – Liquid biopsy-based cancer diagnostics firm Resolution Bioscience today announced its laboratory has received CLIA certification. 

The Washington State Department of Health surveyed Resolution's laboratory and assessed it as having "no deficiencies," the Bellevue-based company said. 

The firm offers the ctDx ALK assay, a blood-based liquid biopsy assay for an ALK gene fusion driver mutation found in non-small cell lung carcinoma, the most common form of the cancer. With the CLIA validation, Resolution can offer the sequencing-based test to researchers and clinicians to guide patients to personalized therapies and to direct them into clinical trials. 

"Our CLIA certification is an important regulatory milestone and demonstrates our ability to create and validate clinically relevant, blood-based tumor genotyping technologies to support our ongoing partnerships with the oncology and pharmaceutical community," Resolution CEO Mark Li said in a statement.

The firm was founded in 2012 and provides physicians and pharmaceutical firms non-invasive tools and technologies to guide the development and clinical implementation of personalized medicine. It said that it is currently validating other liquid biopsy assays, in addition to ctDx ALK, including a targeted actionable multigene panel called ctDx Lung for NSCLC.