MolecularMD Corporation was founded in 2005 by Dr. Brian Druker from Oregon Health and Science University and Sheridan Snyder, the founder of Genzyme Corporation and Upstate Biotechnology. The Company’s mission and vision grew out of the belief that pairing diagnostics with therapeutics will result in improved outcomes.
In 2007, MMD developed and implemented the first standardized assay for the quantification of BCR-ABL1 expression levels in chronic myeloid leukemia, which proved critical to drug developers in the approval of the 2nd generation ABL tyrosine-kinase inhibitors nilotinib (Novartis’ Tasigna) and dasatinib (BMS’ Sprycel), which received FDA approval in 2010 and 2011, respectively. With the initial success of the ABL kinase inhibitors, MMD expanded its Portland facility and the development of the Company’s c-Kit CDx product, used to detect mutational variants in melanoma patients.
MMD continued to fill out its service offerings and in 2011 opened the Cambridge, MA laboratory, which established the Company’s NGS and ctDNA capabilities. The Company continues to have success with BCR-ABL1 capabilities via the submission of the premarket approval (PMA) application for Ariad’s T315I companion diagnostic in 2012. Over time, capabilities and experience have continued to grow, especially in the areas of codevelopment for therapies associated with solid tumors and immuno-oncology.
MMD has over 60 active Master Service Agreements and has executed multiple codevelopment and commercialization agreements with prominent Biopharma clients. The Company’s quality management system achieved ISO 13485 certification in 2015, supporting current good manufacturing practices (cGMP) manufacturing of IVD companion tests, which are considered Class III medical devices by the US FDA.