US-based biopharmaceutical firm Loxo Oncology has entered into a collaboration agreement with Ventana Medical Systems, a division of Switzerland-based healthcare company Roche, to develop and commercialise a companion diagnostic test for experimental drug larotrectinib (LOXO-101).
The diagnostic pan-tropomyosin receptor kinase (TRK) immunohistochemistry (IHC) test will be utilised for the identification of patients across tumour types who can be treated with larotrectinib.
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Larotrectinib is a potent, oral and selective investigational new drug being developed to treat patients with cancers that include abnormalities involving the TRKs.
An investigational assay piloted by Loxo Oncology will be further developed by Roche using the latters OptiView DAB detection technology.
Loxo Oncology chief executive officer Josh Bilenker said: "Our initial technology assessment suggests that an IHC pan-TRK assay is feasible, which is exciting since Roche has thousands of Ventana BenchMark instruments installed worldwide.
"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.”
The diagnostic assay will be optimised and validated to ensure its ability to withstand clinical and regulatory scrutiny.
The firms intend to intially commercialise an analytical assay and later develop a class III assay for pre-market approval (PMA) from the US Food and Drug Administration (FDA).
Roche will develop, obtain and maintain regulatory approvals for the companion diagnostic test in the US, certain countries in the EU and other countries that accept the CE / in-vitro diagnostic registration process.
