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MolecularMD Lands ISO 13485:2003 Certification

NEW YORK (GenomeWeb) – MolecularMD today announced it has received ISO 13485:2003 Certification from the British Standards Institution, recognizing the firm's quality management system for the consistent design, development, and manufacture of in vitro diagnostic medical devices.

Portland, Ore.-based MolecularMD develops custom companion diagnostics and provides clinical trial testing services for targeted cancer therapies over a wide range of platforms including RT-PCR, next-generation sequencing, digital PCR, and immunohistochemistry. The firm has proprietary chemistry and data analysis that allow it to detect indel mutations up to 50 base pairs long and to determine mutation phase.

In December 2014, the firm's Cambridge, Mass., CLIA certified NGS laboratory also received accreditation from the College of American Pathologists.

"The ISO 13485 certification manifests the experience we have accumulated over the last six years in developing molecular diagnostics in concert with oncology therapy programs. MolecularMD can align itself with a broad spectrum of drug-diagnostic strategies, ensuring the appropriate level of quality and regulatory execution with a focus on timeline and risk management," Kevin Hawkins, director of quality and regulatory affairs at MolecularMD, said in a statement.