MolecularMD BCR-ABL T315I Mutation Test regulatory update

MolecularMD voluntarily withdrew a PMA to FDA for its MolecularMD BCR-ABL T315I Mutation Test, a companion diagnostic for Ariad's cancer compound ponatinib to identify chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients who have the T315I mutation. MolecularMD said FDA's Center for Devices and Radiological Health informed the company the test is no longer considered a companion diagnostic because it does not provide information that is "essential" for the safe and effective use of the drug. MolecularMD markets the test on a fee-for-service basis. The company declined to discuss plans to resubmit the PMA. ...