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MolecularMD Gets FDA Authorization for Companion Dx to Novartis CML Drug

NEW YORK (GenomeWeb) – Precision oncology diagnostic firm MolecularMD has received authorization from the US Food and Drug Administration for a test to help physicians determine whether a patient with chronic myeloid leukemia (CML) can stop treatment with Novartis' drug Tasigna (nilotinib). 

MolecularMD's test, called MRDx BCR-ABL, uses qPCR to measure BCR-ABL transcripts from peripheral blood specimens in Philadelphia chromosome-positive (Ph+) CML patients. The assay has been authorized as an aid in identifying Ph+ CML patients chronically treated with the BCR-ABL tyrosine kinase inhibitor Tasigna who are candidates for discontinuation and monitoring of treatment-free remission. Patients in remission would no longer take Tasigna, but would, instead, be monitored with the Ph+ CML test indefinitely.

Patients who have taken Tasigna for three years or more and whose CML is responding according to certain criteria would be candidates for discontinuation, according to the FDA. "Monitoring with a test able to detect reductions of [BCR-ABL RNA] with high accuracy and precision is critical to the safe discontinuation of Tasigna, as this monitoring provides the first signs of relapse," the agency said in a statement

The MolecularMD test is also CE marked and the firm intends to make it broadly available, according to a statement.

MolecularMD began a partnership in 2014 with Novartis to develop a CML monitoring test for Tasigna. Its assay is the only test authorized by the FDA for monitoring deep molecular response in treatment-free remission patients, MolecularMD said. A digital PCR-based assay from Bio-Rad for monitoring remission of CML was CE marked earlier this month. Novartis also partnered with Cepheid in 2010 to develop a PCR-based test on the GeneXpert platform to measure BCR-ABL transcripts in Ph+ CML patients.