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MolecularMD Seeks FDA Clearance for Leukemia Drug Companion Dx

NEW YORK (GenomeWeb News) – MolecularMD has submitted a Premarket Approval application with the US Food and Drug Administration for a companion diagnostic test to leukemia drug ponatinib.

The Portland, Ore.-based firm said after the close of the market Monday that it had filed for clearance of its BCR-ABL T315I Mutation Test, which detects the T315I mutation in BCR-ABL RNA transcripts in blood using Sanger sequencing technology. It said the test can identify patients with chronic myeloid leukemia and Philadelphia positive acute lymphoblastic leukemia who have the mutation.

The test is a companion to Ariad Pharmaceuticals' ponatinib, a multi-targeted kinase inhibitor that the drug firm is submitting to FDA for approval as a treatment for patients with resistant or intolerant CML or Ph+ ALL, including those patinets with the T315I mutation.

"We have worked closely in partnership with ARIAD to perform all the mutation testing for the pivotal PACE trial of ponatinib and at the same time, complete the in vitro diagnostic test development and PMA submission," MolecularMD President Dan Snyder said in a statement. "We are among the first partnerships to submit an NDA and a PMA to the FDA for simultaneous consideration, following the draft guidance set forth by the FDA in July 2011."

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