MolecularMD Withdraws Premarketing Approval Application from FDA for its BCR-ABL T315I Mutation Test

MolecularMD Corp. and ARIAD Pharmaceuticals

today announced that MolecularMD has voluntarily withdrawn its Premarketing Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its BCR-ABL T315I Mutation Test.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.”