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Thermo Fisher Scientific, Eli Lilly to Develop CDx for RET Inhibitor

NEW YORK (GenomeWeb) – Thermo Fisher Scientific said today that it has signed an agreement with Eli Lilly and Company to develop a companion diagnostic for Lilly's RET kinase inhibitor, LOXO-292.

The companies plan to use Thermo Fisher's Oncomine Dx Target test, a sequencing panel that is approved by the US Food and Drug Administration, to identify non-small cell lung cancer and thyroid cancer patients with RET alterations who might benefit from LOXO-292.

Lilly is currently testing LOXO-292, an oral RET inhibitor, in a Phase I/II clinical trial for the treatment of advanced cancers with activating alterations of the RET kinase.

Under the terms of the agreement, Thermo Fisher will retain the rights to commercialize the test globally, including in the US, Europe, and Japan. Following validation, Thermo Fisher plans to submit a supplemental premarket approval application to the FDA to broaden the clinical claims of the Oncomine Dx Target test.

"With this agreement, we believe that more patients will gain access to high-quality tumor profiling, identifying those with RET alterations potentially suitable for LOXO-292 therapy, in addition to other alterations suitable for treatment with other therapies," said Anne White, president of Lilly Oncology, in a statement.

"We are pleased to enter into this agreement with Lilly and leverage our Oncomine platform as a means to quickly identify cancer patients who may benefit from this breakthrough therapy, even in cases of limited sample availability," said Mark Stevenson, executive VP and COO of Thermo Fisher, in a statement.

The Oncomine Dx Target test screens tumor samples for multiple gene variants that are associated with NSCLC, some of which can identify patients who may be eligible for several approved targeted therapies. The test, which received FDA approval in 2017, is covered by the Centers for Medicare & Medicaid Services and by several large commercial health plans in the US. It is also approved for reimbursement by the Japan Ministry of Health, Labor, and Welfare.