March 26, 2015
MolecularMD Receives ISO Certification for Design, Development and Production of Molecular Diagnostic Products
PORTLAND, OR and CAMBRIDGE, MA – March 26, 2015 – MolecularMD Corp., a molecular diagnostics company that develops custom companion diagnostics and provides clinical trial testing services for targeted cancer therapies, today announced the recent certification by BSI (British Standards Institution) of its Quality Management System to the requirements of ISO 13485:2003.
The ISO 13485 standard sets the comprehensive requirements for a quality management system (QMS) in the consistent design, development and manufacture of in vitro diagnostic medical devices. Adopting ISO 13485 provides a practical foundation for MolecularMD to demonstrate compliance to laws and regulations of the medical device industry while ensuring that its medical devices are safe for their intended purpose.
The integration of multiple CLIA/CAP certified molecular diagnostic testing laboratories with the ISO 13485 standard allows for rapid and cost effective translation of biomarkers into validated In Vitro Diagnostics (IVD). MolecularMD develops tests over a wide range of platforms including RT-PCR, Next Generation Sequencing, digital PCR and Immunohistochemistry.
“The ISO 13485 certification manifests the experience we have accumulated over the last 6 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,” stated Kevin Hawkins, RAC, Director, Quality and Regulatory Affairs at MolecularMD.
The company partnered with ARIAD Pharmaceuticals to support the approval of ponatinib in the US and EU and is currently working with multiple high value targeted therapy programs seeking regulatory approval for a wide range of targets and tumor types. MolecularMD’s unique combination of design and development pathways allows for a nimble and cost effective approach that can support both early and late stage oncology programs that typically address niche patient populations with a critical need for improved treatment options.