May 20, 2015

Resolution Bioscience Receives CLIA Certification for its Diagnostic Laboratory and Launches CLIA-Certified Liquid Biopsy for Lung Cancer.

Resolution Bioscience announced today the successful results from their CLIA validation of ctDx ALK™, a blood-based liquid biopsy for an ALK-gene fusion driver mutation found in non-small cell lung carcinoma (NSCLC), the most common form of this cancer. Researchers or clinicians can now use the test to guide patients to personalized therapies and direct them into clinical trials with a standard blood sample.

Resolution Bio is committed to the highest operational and quality standards. 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.”

— Mark Li, CEO

The Resolution Bio platform combines the cost and speed advantages of a desktop sequencer with proprietary library construction and bioinformatics to deliver comprehensive results in as little as a week.

The Resolution Bio ctDx platform’s key attributes:

  • Report hotspots, insertions & deletions, amplifications and fusions from a single test
  • Fusion detection without prior knowledge of partner or breakpoint
  • Clinically-relevant 7-day turnaround
  • Uses a standard desktop sequencer
  • Just 10ml of blood

Importantly, any accredited molecular lab could, with the right technical expertise and bioinformatics support, implement this assay to guide the care of advanced NSCLC patients. The platform is easily accessible to other target genomic regions and thus extendable to additional indications and targeted therapies.

Resolution is currently validating additional blood-based liquid biopsy assays, including a targeted, actionable multi-gene panel for NSCLC, ctDx Lung™, for clinical use in support of the company’s research and pharmaceutical collaborators. In April 2015, results demonstrating the high specificity and sensitivity of the Resolution platform were presented at the annual AACR conference in Philadelphia.

About Resolution Bioscience Inc.
Resolution Bioscience (Bellevue, WA) was founded in 2012 by leading experts in next generation sequencing, genomic analysis and commercial product development. The company’s mission is to transform cancer outcomes by providing physicians and pharmaceutical companies with clinic-ready, noninvasive tools and technologies to guide the development and clinical implementation of personalized treatment strategies.