Thermo Fisher Scientific has received approval from the U.S. Food and Drug Administration (FDA) for its Oncomine Dx Target Test, a next-generation sequencing (NGS)-based companion diagnostic (CDx). This test is crucial for identifying patients with non-small cell lung cancer (NSCLC) who are eligible for a new targeted therapy called HERNEXEOS® (zongertinib tablets), developed by Boehringer Ingelheim.

HERNEXEOS is the first and only orally administered targeted treatment specifically for adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain activating mutations. These mutations are relatively rare, affecting approximately 2 to 4 percent of NSCLC patients, and are associated with a poor prognosis. The drug's approval was granted under the FDA's accelerated approval pathway, based on its demonstrated objective response rate and duration of response, with continued approval contingent on a confirmatory trial.

The Oncomine Dx Target Test, which received its first FDA approval in 2017, has a strong track record as a companion diagnostic for multiple therapies across various cancer types. It is reimbursed by government and commercial insurers in several countries, covering over 550 million lives globally. This new approval for HERNEXEOS further solidifies Thermo Fisher's leadership in the field of companion diagnostics and demonstrates its ongoing commitment to providing timely and accessible solutions that support pharmaceutical partners and ultimately, patient health.