In the relatively nascent medical field of molecular oncology, MolecularMD distinguishes itself by providing 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 partnership with ARIAD.
Whether it is a test based on MolecularMD’s Intellectual Property, or an assay transferred to our team by a pharma partner, we have the components in place to develop Companion Diagnostics that meet the latest regulatory guidelines. Our CDx development capabilities include custom assay design based on partner preferences and practicalities related to the biomarker(s) being evaluated. We employ a variety of molecular approaches, from traditional Sanger sequencing and quantitative RT-PCR to more recently-developed NextGen technologies for sequencing and biomarker detection/quantification. In each category we remain agnostic as to 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.