MolecularMD Corp. and ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that MolecularMD has voluntarily withdrawn its Premarketing Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its BCR-ABL T315I Mutation Test. The test detects the BCR-ABL T315I mutation in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) patients. The MolecularMD BCR-ABL T315I Mutation Test was intended as a companion diagnostic for use in conjunction with ARIAD’s investigational BCR-ABL inhibitor, ponatinib, which is currently under review by the FDA for marketing approval in the U.S.
MolecularMD was recently informed by the FDA’s Center for Devices and Radiological Health that its BCR-ABL T315I Mutation Test is no longer considered to be a companion diagnostic test for ponatinib. FDA guidance states that for a clinical laboratory test to be granted a PMA as a companion diagnostic test, the test must provide information that is essential for the safe and effective use of a therapeutic product.
“The input provided by the Agency to MolecularMD regarding its T315I mutation test indicates that the T315I mutation test is no longer required as a companion diagnostic test to identify patients with the BCR-ABL T315I mutation who may be treated with ponatinib,” stated Harvey J. Berger, M.D. chairman and chief executive officer of ARIAD. “We look forward to continuing our longstanding collaboration with MolecularMD, the world leader in BCR-ABL testing, in clinical trials of ponatinib in patients with CML.”
“We are pleased to see ponatinib moving forward in its U.S. regulatory review and look forward to continuing our close involvement with its ongoing and future clinical development as a premier companion diagnostic partner ,” stated Dan Snyder, President, Chief Operation Officer of MolecularMD.About MolecularMD MolecularMD Corporation is a specialty Companion Diagnostics provider that develops and commercializes molecular diagnostics for oncology applications. Its tests are designed to allow appropriate selection, monitoring and management of patients treated with molecularly-targeted cancer therapies. MolecularMD incorporates gold-standard and innovative technologies in meeting our partners’ most demanding requirements and providing the highest quality results. A private company based in Portland, Oregon, MolecularMD was founded by Brian Druker, director of the Knight Cancer Center at Oregon Health & Science University, and Sheridan G. Snyder, entrepreneur and founder of Genzyme Corporation.