(By Balaseshan) Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) said specialty companion diagnostics provider MolecularMD Corp. has voluntarily withdrawn its premarket approval application for its BCR-ABL T315I mutation test.
The mutation 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 U.S. Food and Drug Administration (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.
"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," stated Harvey Berger, chairman and chief executive officer of ARIAD.
ARIA closed Monday's regular session at $23.50. The stock has been trading between $7.72 and $23.72 for the past 52 weeks.