Cambridge, Mass — ARIAD Pharmaceuticals, Inc, and Portland, Ore-based MolecularMD Corporation have announced an exclusive collaboration agreement in which MolecularMD will develop and commercialize a companion diagnostic test to identify the T315I mutation of the BCR-ABL gene in patients with chronic myeloid leukemia (CML) and Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL). http://www.clpmag.co...11-04-06_09.asp
Ariad, MolecularMD To Develop Diagnostic Test For CML Patients - T315I mutation
Posted 31 May 2011 - 09:29 PM
The FDA has criticized existing T315i mutation testing processes, calling them "unvalidated". I assume ARIAD is responding to this problem, since they must assure the FDA that they have properly identified patients with T315i if they are going to claim that their drug has benefitted these same patients.
The FDA refused another drug approval (Omacetaxine) saying it required "a well characterized in vitro diagnostic to identify patients with the T315I mutation...and correlated to clinical trial results" before it would approve the drug.
Either way this news is good for CML patients. Better testing means better care. Testing is the achilles heel of leukemia treatment.
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