The test aims to accelerate lung cancer treatment research
Life science manufacturing company Thermo Fisher Scientific has received approval from the FDA for its Ion Torrent Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for Hyrnuo, a HER2-directed therapy developed by Bayer.
“The power of precision medicine starts with accurate, timely genomic insights that help providers match patients to the right therapies,” said Thermo Fisher Scientific president of clinical next-generation sequency Kathy Davy.
“Our experience as a companion diagnostics partner of choice for pharmaceutical companies allows us to support the development of new therapies, accelerate access and help clinicians make the best possible decisions for their patients.”
The test helps pathologists and clinicians to identify non-small cell lung cancer (NSCLC) tumours with certain HER2/ERBB2 tyrosine kinase domain (TKD) activating mutations. NSCLC represents approximately 87% of all lung cancer cases.
The FDA also approved Hyrnuo for the treatment of adult patients with locally advanced or metastatic non-squamous NSCLC harbouring HER2 TKD activating mutations.
Patients with NSCLC presenting with HER2 mutations could benefit from this more targeted treatment.
“We are committed to advancing innovation for patients with difficult-to-treat cancers, and this approval marks another step forward in ensuring all patients with cancer have access to optimal treatment options,” said Bayer VP, global head of translational sciences oncology Emmanuelle Di Tomaso.
“Collaborating with Thermo Fisher to leverage the Oncomine Dx Target Test allows us to ensure clinical teams can identify patients who are most likely to benefit from Hyrnuo, supporting timely and informed treatment decisions in real-world clinical settings.”
