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MolecularMD Withdraws PMA for Leukemia CDx

NEW YORK (GenomeWeb News) – MolecularMD and Ariad Pharmaceuticals today said that MolecularMD has withdrawn its premarket approval application to the US Food and Drug Administration for its BCR-ABL T315I Mutation Test.

MolecularMD's test detects the BCR-ABL T315I mutation in chronic myeloid leukemia and Philadephia-chromosome positive acute lymphoblastic leukemia patients and was intended as a companion diagnostic for Ariad's investigational BCR-ABL inhibitor, ponatinib, currently being reviewed by FDA.

According to FDA guidelines, a clinical laboratory test is granted a PMA as a companion diagnostic when the test provides information that is essential for the safe and effective use of a therapeutic product. The agency's Center for Devices for Radiological Health recently told MolecularMD that its test is no longer considered a companion diagnostic for ponatinib, according to MolecularMD and Ariad.

In a statement, Ariad Chairman and CEO Harvey Berger said, "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."

He added that his firm will continue collaborating with MolecularMD in clinical trials of ponatinib in patients with chronic myeloid leukemia.

MolecularMD and Ariad began a partnership developing the test in March 2011, and this past July Molecular MD submitted its PMA application for the test to the FDA.

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