Thermo Fisher to develop companion diagnostic test for use with Eli Lilly's RET inhibitor

Thermo Fisher Scientific announced Monday that it entered an agreement to develop a companion diagnostic that will use its next-generation sequencing (NGS)-based Oncomine Dx target test to identify certain patients with non-small-cell lung cancer (NSCLC) and thyroid cancer who may be suitable for treatment with Eli Lilly's investigational RET inhibitor LOXO-292.

Mark Stevenson, chief operating officer of Thermo Fisher, remarked that the Oncomine Dx platform will be used "as a means to quickly identify cancer patients who may benefit from this breakthrough therapy, even in cases of limited sample availability." Meanwhile, Anne White, president of Lilly Oncology, said "with this agreement, we believe that more patients will gain access to high-quality tumour profiling, identifying those with RET alterations potentially suitable for LOXO-292 therapy, in addition to other alterations suitable for treatment with other therapies."

Under the agreed terms, Thermo Fisher will retain the rights to commercialise the test in all markets, including the US, Europe and Japan. Once validation is complete, Thermo Fisher will submit an FDA application to broaden the clinical claims of its Oncomine Dx target test.

The NGS-based test, which received FDA approval in 2017 as the first such test that simultaneously screens tumour samples for biomarkers associated with three approved targeted therapies for NSCLC, is covered by the US Centers for Medicare & Medicaid Services and is also cleared for reimbursement coverage in Japan.

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