What's Happening?
Thermo Fisher Scientific has received FDA approval for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic to identify patients eligible for Bayer's new HER2-directed therapy, HYRNUO™ (sevabertinib).
This test helps clinicians and pathologists identify non-small cell lung cancer (NSCLC) tumors with HER2/ERBB2 tyrosine kinase domain activating mutations, determining which patients may benefit from the therapy. The approval of both Bayer's therapy and Thermo Fisher's diagnostic test aims to close access gaps, ensuring labs have essential companion testing available as soon as the drug is released.
Why It's Important?
The approval of the Oncomine Dx Target Test is a crucial development in precision medicine, particularly for patients with NSCLC, which represents a significant portion of lung cancer cases. The test provides targeted treatment options for a disease with traditionally limited therapeutic options and poor prognosis. By enabling timely and informed treatment decisions, the test supports the advancement of innovation for patients with difficult-to-treat cancers. The broad reimbursement coverage makes the test accessible to millions worldwide, enhancing the ability to match patients with optimal treatment options.
What's Next?
Thermo Fisher Scientific plans to continue collaborating with pharmaceutical companies to support the development of new therapies and accelerate access to precision medicine. The Oncomine Dx Target Test will be used alongside multiple therapies for NSCLC and other tumor types, expanding its application in real-world clinical settings. The company aims to leverage its experience as a companion diagnostics partner to help clinicians make the best possible decisions for their patients.
