Oncology Drug Approval - Accelerated

Bridging the gap between biomarkers and In Vitro Companion Diagnostics

Companion Diagnostics Development

CDx Capabilites

  • ISO 13485 Design Controls
  • Regulatory Expertise
  • cGMP Manufacturing Capabilities
  • Strategic Global Distribution Partners
  • Physician Support
  • Established Reimbursement Network

The cancer diagnostics space, including companion diagnostics, is well into an evolutionary process advancing towards highly multiplexed, biomarker analysis and workup for each cancer patient. However, one size does not fit all when it comes to coupling a diagnostic with a drug program. Well organized and thought out product requirements are necessary to reduce risk and support commercial strategy of each drug.

MolecularMD provides high-quality biomarker diagnostic services that support registration of targeted oncology therapeutics.  Among its successes, MolecularMD’s testing evaluated the primary endpoint that led to FDA approval of nilotinib as first-line therapy for CML.  N Engl J Med 2010; 362:2251-2259.

This experience informs and inspires our Companion Diagnostics Development activities.  Building on our industry-leading molecular diagnostics services performed in our CLIA-certified laboratory, we have layered on systems and expertise that enable us to provide the IVD development capabilities that make us an ideal CDx partner.  Read more about our CDx collaboration with Novartis.

Oncology Drug Approval - Accelerated

In each category we remain agnostic regarding the platform provider and retain the flexibility to select the technology that best suits the project, the preferences of the partner, and the ultimate market profile for the IVD.  We work collaboratively with our pharma partners to establish and maintain critical project timelines; we appreciate the importance of simultaneous CDx submission to successful registration of the therapeutic.

Please contact MolecularMD to discuss collaborative or partnering opportunities.

Oncology Thought Leaders Series:
Brian Druker, MD speaks on the value of
companion diagnostics in patient outcomes