The US Food and Drug Administration (FDA) has granted approval for Thermo Fisher Scientific’s Oncomine Dx Target Test as a treatment for non-small cell lung cancer (NSCLC).
The test serves as a companion diagnostic (CDx) to detect NSCLC patients eligible for Hernexeos (zongertinib tablets), a treatment developed by Boehringer Ingelheim.
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The test enables clinicians and pathologists to detect human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations in NSCLC tumours.
Since its initial approval from the FDA as a next-generation sequencing (NGS) CDx in 2017, the test has received regulatory approvals in 20 nations for 11 biomarkers and more than 20 targeted therapies, with availability varying by region.
Reimbursement for the test is provided by both government and commercial insurers across various regions, including Israel, Europe, Japan, the US, and South Korea.
In the US, the Oncomine Dx Target Test has been sanctioned for use with targeted therapies for various cancers, including anaplastic thyroid cancer, astrocytoma, cholangiocarcinoma, medullary thyroid cancer, NSCLC, oligodendroglioma, and thyroid cancer.
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By GlobalDataThermo Fisher Scientific clinical next-generation sequencing president Kathy Davy said: “The FDA’s approval of Hernexeos for previously treated patients living with HER2 (ERBB2)-mutant advanced non-small cell lung cancer signifies continued success in our efforts to develop timely and accessible companion diagnostics.
“We’re continuing to expand our solutions for our pharma partners, as this approval quickly follows the recent FDA approval of our latest rapid NGS solution that can deliver results in as little as 24 hours.”
Hernexeos has been granted accelerated approval by the FDA as the first oral targeted therapy for the adult population with unresectable or metastatic non-squamous NSCLC with HER2 mutations, as identified by the FDA-approved test, following previous systemic therapy.
This approval is supported by the duration of response and objective response rate, with continued approval potentially dependent on the outcomes of a confirmatory trial.
According to the company, lung cancer ranks as the second most prevalent cancer among US men and women, with NSCLC accounting for approximately 85%–90% of all lung cancer cases.
Within this patient population, approximately 2% to 4% are said to exhibit a HER2 mutation.
In April, Thermo Fisher allocated $2bn to widen manufacturing and development within the US, aligning with a trend of companies investing in domestic operations amid concerns that ongoing US tariffs could disrupt global trade.
