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Loxo Oncology, Ventana Medical Systems Partner to Develop CDx

NEW YORK (GenomeWeb) – Loxo Oncology announced today that it has formed a collaboration with Roche subsidiary Ventana Medical Systems to develop and commercialize a test to identify patients likely to respond to the cancer drug larotrectinib.

Loxo's larotrectinib — also known as LOXO-101 — is an oral inhibitor of tropomyosin receptor kinases (TRK), a family of proteins associated with cellular signaling and tumor growth. The drug is currently under phase I and II testing as a treatment for tumors with TRK fusions.

Under the terms of the companies' deal, they will use Ventana's OptiView DAB detection technology to develop an investigational assay created by Loxo into a pan-TRK immunohistochemistry (IHC)-based companion diagnostic for larotrectinib. Loxo and Ventana will jointly optimize and validate the test, which they plan to initially commercialize as an analytical assay. They will then pursue premarket approval from the US Food and Drug Administration for the assay based on analyses of patient samples collected during the drug's development.

Ventana will be responsible for developing, obtaining, and maintaining regulatory approvals for the companion diagnostic test in the US, certain undisclosed countries in the European Union, and other countries that recognize the CE mark/in vitro diagnostic registration process.

Additional terms of the deal were not disclosed.

"Our initial technology assessment suggests that an IHC pan-TRK assay is feasible," Loxo CEO Josh Bilenker said in a statement. "Diagnostics are a crucial part of our commercial strategy, and we believe IHC will be an important tool, alongside next-generation sequencing, that pathologists can employ in screening for patients who may benefit from larotrectinib."