MolecularMD Corp. has submitted its application for premarket approval of its MolecularMD BCR-ABL T315I Mutation Test. This test detects the T315I mutation in BCR-ABL RNA transcripts in blood using Sanger sequencing technology. The MolecularMD test can be used to identify patients with chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL) who have the T315I mutation; the test is intended as a companion diagnostic to ponatinib. Ponatinib, a BCR-ABL inhibitor developed by ARIAD Pharmaceuticals Inc., is being submitted for approval for the treatment of patients with resistant or intolerant CML or Ph+ ALL, including those with the T315I mutation.
The test service employs bidirectional Sanger sequencing to detect the T315I mutation in the predominant BCR-ABL transcripts that account for over 95% of gene fusion products in CML and Ph+ ALL cases. If approved, the Molecular MD BCR-ABL T315I Mutation Test would be the first BCR-ABL sequencing test approved by FDA and the first service-based LDT to be approved by the FDA as a companion diagnostic. Pending approval, the MolecularMD BCR-ABL T315I Mutation Test will facilitate identification of CML and Ph+ ALL patients who are candidates for ponatinib treatment.
BCR-ABL mutation testing for the PACE trial, the pivotal phase 2 trial of ponatinib, was exclusively performed by MolecularMD.