US-based life science company Thermo Fisher Scientific has secured the US Food and Drug Administration (FDA) approval for its Oncomine Dx Target Test.
The combined diagnostic (CDx) test is designed to identify lung cancer patients eligible for receiving Boehringer Ingelheim’s Hernexeos (zongertinib tablets).
Hernexeos is a tyrosine kinase inhibitor indicated for the treatment of non-small cell lung cancer (NSCLC) with HER2 mutations.
The US FDA recently approved Hernexeos as the first oral therapy for patients with HER2-mutant NSCLC, contingent on further clinical trials to confirm its benefits.
The approval of Oncomine Dx Target Test marks a significant development in targeted cancer therapies.
Thermo 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.”
The Oncomine Dx Target Test initially received FDA approval as a next-generation sequencing companion diagnostic in 2017.
The test has since gained regulatory approval in 20 countries for 11 biomarkers and over 20 targeted therapies.
It is covered by insurers in the US, Europe, Japan, South Korea, and Israel, impacting over 550 million lives worldwide.
In the US, the companion diagnostic is approved for use in various cancers, including NSCLC, cholangiocarcinoma, and thyroid cancer.
Boehringer Ingelheim senior vice president and immunology, oncology, and eye health head Vicky Brown said: “This rare form of non-small cell lung cancer is linked to a poor prognosis and limited treatment options, making Hernexeos an important advancement in addressing the unmet needs of patients.
“Through our collaboration with Thermo Fisher and leveraging the company’s proven track record with companion diagnostics, we’re pleased that patients have another tool that can be used to identify those with HER2 (ERBB2) tyrosine kinase activating mutations in non-small cell lung cancer.”
