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Foundation Medicine, Boehringer Ingelheim Collaborate on CDx for Biliary Tract Cancer Drug

NEW YORK – Roche subsidiary Foundation Medicine announced on Thursday that it is partnering with Boehringer Ingelheim to develop a companion diagnostic for the pharmaceutical firm's biliary tract cancer drug.

The companies will develop the tissue-based FoundationOne CDx test as a companion diagnostic for BI 907828 in the US, Japan, and the EU, Foundation said in a statement. The drug is an investigational, oral, small molecule MDM2-p53 antagonist. It is being evaluated as monotherapy in Brightline-2, an ongoing Phase IIa/IIb multicenter trial for the treatment of patients with locally advanced or metastatic, MDM2 amplified, TP53 wild-type biliary tract cancer who have progressed on standard of care therapy.

FoundationOne CDx is a next-generation sequencing-based test that detects substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements. It also detects genomic signatures like microsatellite instability and tumor mutational burden.