MolecularMD, ARIAD Pharma (ARIA) Withdraw BCR-ABL T315I Mutation Test PMA App
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MolecularMD Corp. and ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) announced that MolecularMD has voluntarily withdrawn its Premarketing Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its BCR-ABL T315I Mutation Test.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.
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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.
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