MolecularMD and Ariad Pharmaceuticals, Inc. Announce Voluntary Withdrawal of MolecularMD's Premarket Approval Application for BCR-ABL T315I Mutation Test
Published: Sep 18, 2012
PORTLAND, Ore. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 and ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that MolecularMD has voluntarily withdrawn its Premarketing Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its BCR-ABL T315I Mutation Test.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.