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Thermo Fisher Gets FDA OK for CDx Test to Guide Use of Lilly Drug in Lung, Thyroid Cancers

NEW YORK – Thermo Fisher Scientific said on Tuesday that its next-generation sequencing-based Oncomine Dx Target Test has been approved by the US Food and Drug Administration as a companion diagnostic (CDx) to identify patients with advanced RET-driven lung and thyroid cancers who may be eligible for Lilly’s Retevmo (selpercatinib).

This is the Oncomine Dx Target Test's first approval as a CDx for a therapy targeting RET-positive thyroid cancer and its second approval in RET-positive non-small cell lung cancer (NSCLC). Thermo Fisher said its test can simultaneously detect multiple alterations in limited samples, and noted that it is also approved in Japan as a CDx for Retevmo in the same indications.

Retevmo was initially approved by the FDA in 2020 as a selective RET kinase inhibitor for patients with advanced RET-driven lung and thyroid cancers. Last week, it received accelerated tumor-agnostic FDA approval for treatment of patients with tumors bearing RET gene fusions.

"Following the Oncomine Dx Target Test’s first approval in 2017, we have worked to advance access to companion diagnostics for targeted therapies on a global scale," Garret Hampton, Thermo Fisher’s president of clinical next-generation sequencing and oncology, said in a statement. "As we continue to pursue additional approvals alongside our biopharma partners, we remain committed to broadening access to NGS-based testing to ensure patients and clinicians everywhere can benefit from it."