10:54 AM EDT, 08/11/2025 (MT Newswires) -- Thermo Fisher Scientific ( TMO ) said Monday it has received the US Food and Drug Administration's approval for its Oncomine Dx Target Test to help identify patients with non-small cell lung cancer who may be eligible for HERNEXEOS.

The test detects HER2, or ERBB2, tyrosine kinase domain mutations in NSCLC tumors, allowing clinicians to determine if patients could benefit from this targeted therapy, the company said.

The FDA approved HERNEXEOS on Aug. 8 as the first oral targeted therapy for adults with unresectable or metastatic non-squamous NSCLC with HER2 mutations who have previously received systemic therapy, it added.

The Oncomine Dx Target Test was first FDA-approved in 2017 and is now authorized in 20 countries for multiple biomarkers and more than 20 targeted therapies, according to the company.

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