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Abbott Inks CDx Development, Commercialization Deals With Celgene, Agios

NEW YORK (GenomeWeb) – Abbott has inked deals with Celgene and Agios Pharmaceuticals to develop and commercialize PCR-based companion diagnostic tests that will identify isocitrate dehydrogenase (IDH) mutations in patients with acute myeloid leukemia.

Celgene and Agios will run the companion diagnostic tests on Abbott's m2000 RealTime System, a PCR instrument designed to enable clinical laboratories to automate the PCR process and analysis of results. It will simplify complex and manual steps involved in molecular diagnostics, the biopharma firms said, adding that they have incorporated this type of screening into clinical trial designs.

"IDH mutations lead to aberrant DNA methylation, causing a block in myeloid differentiation that leads to disease progression," Han Myint, Celgene's vice president of global medical affairs for MDS/AML, said in a statement. "Molecular profiling is important to identify genomic mutations which may have prognostic and potential treatment implications for patients with AML."

IDH mutational analysis should become part of the routine AML diagnostic workup, according to an article published online this week in the journal Leukemia.

IDH1 and IDH2 mutations occur in around 20 percent of AML patients. Agios is developing AG-120, an IDH1 mutant inhibitor for the treatment of patients with relapsed or refractory AML who have an IDH1 mutation. Celgene is developing enasidenib, an IDH2 mutant inhibitor for the treatment of patients with relapsed or refractory AML who have an IDH2 mutation.

The m2000 system has not been FDA cleared or approved for use with enasidenib or AG-120, the firms noted, and the mutant inhibitors have not been approved for use anywhere.