The world leader when it comes to serving science, Thermo Fisher Gets FDA Approval for the Oncomine Dx Target Test as a companion diagnostic (CDx) in order to identify patients who might as well be the candidates for HERNEXOS, a tyrosine kinase inhibitor (TKI) that is developed by Boehringer Ingelheim. As Thermo Fisher Gets FDA Approval, this test would enable the clinicians as well as pathologists to evaluate if non-small-cell lung cancer (NSCLC) tumors harbor the human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations.
It is well to be noted that lung cancer happens to be the second most common cancer in both men and women in the United States, with NSCLC comprising almost 85% to 90% of all lung cancer cases. Among those who are diagnosed with NSCLC, almost 2 to 4% happen to present with the HER2 mutation. The FDA went on to approve HERNEXEOS on August 8, 2025, as the first and only orally administered targeted therapy when it comes to adult patients having unresectable or metastatic non-squamous non-cell lung cancer (NSCLC) whose tumors happen to have HER2 tyrosine kinase domain activating mutations as pinpointed by the FDA-approved test and who have gone on to receive the prior systemic therapy. This indication was given the approval under the accelerated approval based on the objective response rate as well as duration of response. Continued approval for this indication may be contingent on verification as well as the description of clinical advantages in a confirmatory trial.
According to the senior vice president and head of immunology, oncology, and eye health at Boehringer Ingelheim, Vicky Brown, this rare form of non-small cell lung cancer happens to be linked to a poor prognosis as well as limited treatment choices, thereby making HERENEXOS a very significant advancement when it comes to addressing the unmet requirements of patients. By way of their collaboration with Thermo Fisher and through making utmost use of the proven track record of the company pertaining to companion diagnostics, they are indeed pleased that patients have another tool that can be made use of so as to identify those with HER2 tyrosine kinase activating mutations within non-small cell lung cancer.
Apparently, the Oncomine Dx target went on to receive its first approval by the FDA as an NGS CDx in 2017, which was followed by regulatory approvals across 20 countries when it came to its 11 biomarkers and more than 20 targeted therapies. The test is reimbursed by the government and commercial insurance across the regions of the US, Japan, Europe, South Korea, and Israel, thereby covering over 550 million lives across the world. In the US alone, it has been approved for targeted therapy within NSCLC, cholangiocarcinoma–CC, oligodendroglioma–OG, astrocytoma–AC, anaplastic thyroid cancer–ATC, thyroid cancer–TC, and modular thyroid cancer–MTC.
As per the president of clinical next-generation sequencing with Thermo Fisher Scientific, Kathy Davy, the approval by the FDA of HERNEXEOS for the previously treated patients having HER2 mutant advanced non-small cell lung cancer goes on to signify the consistent success in their efforts in order to develop timely as well as accessible companion diagnostics. They are continuing to expand their solutions when it comes to their pharma partners since this approval rapidly follows the recent approval by the FDA of their latest rapid NGS solution, which can go on to deliver results in as less as 24 hours.
