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Foundation Medicine, Repare Therapeutics Partner to Develop CDx for Lunresertib

NEW YORK – Roche subsidiary Foundation Medicine said Wednesday that it has partnered with Repare Therapeutics to provide genomic profiling services for Repare's clinical trial and to potentially develop a companion diagnostic for Repare's lunresertib. 

Foundation will provide prospective genomic profiling to patients in Repare's ongoing Phase I/Ib MYTHIC study investigating the use of lunresertib alone or in combinations in genomically defined patients. The companies are also considering developing the tissue-based FoundationOne CDx test as a companion diagnostic for lunresertib, Foundation said in a statement. 

Lunresertib is an oral small molecule inhibitor of PKMYT1 that Repare discovered and identified as lethal to cancer cells with CCNE1 amplification and FBXW7 and PPP2R1A alterations. It is being evaluated both alone and in combinations in multiple studies across North America and Europe. 

"High-quality companion diagnostics are critical to inform treatment decisions, and they are especially important for detecting complex biomarkers in patients without any therapeutic options," Foundation Medicine Chief Biopharma Business Officer Troy Schurr said in a statement. "We're proud to partner with Repare Therapeutics as they work to advance this potential first-in-class therapy for patients with high unmet need." 

FoundationOne CDx is a next-generation sequencing-based test that detects substitutions, insertions, deletions, and copy number alterations in 324 genes and select gene rearrangements using DNA isolated from formalin-fixed, paraffin-embedded tumor tissue samples. It also detects genomic signatures including microsatellite instability and tumor mutational burden.