Thermo Fisher Scientific has gained US Food and Drug Administration (FDA) approval for its Ion Torrent Oncomine Dx Target Test, which can identify patients with Grade 2 IDH-mutant glioma.
The Ion Torrent Oncomine Dx Target Test will serve as a companion diagnostic (CDx) to identify patients eligible for Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets.
Voranigo is an IDH1 and IDH2 inhibitor for treating Grade 2 astrocytoma or oligodendroglioma in adults and paediatric patients aged 12 and older. This treatment targets those with specific IDH1 or IDH2 mutations after surgery.
It is said to be the first targeted therapy for Grade 2 IDH-mutant glioma. Voranigo secured FDA approval in August 2024.
Servier Pharmaceuticals CEO David Lee said: “Voranigo is the first and only targeted therapy for patients living with grade 2 IDH mutant glioma, a relentless and incurable type of brain cancer that hasn’t seen treatment advances in nearly 25 years.
“As more targeted therapies become available to patients, identifying key driver mutations is essential to help the right patients find the right treatment, at the right time.”
The Oncomine Dx Target Test has previously received FDA approval for IDH-mutant diffuse glioma.
It also secured approval for non-small cell lung cancer (NSCLC) in August 2022. Additionally, the test has approvals for cholangiocarcinoma (CCA), medullary thyroid cancer (MTC), and thyroid cancer (TC).
As a distributable CDx, the test provides biomarker results for multiple targeted therapies from a single sample. This helps quickly match patients with the most appropriate treatments, Thermo Fisher Scientific claimed.
Thermo Fisher Scientific clinical next-generation sequencing president Kathy Davy said: “As the healthcare system works to realise the impact of precision medicine, patients must have access to the proper testing that helps unlock targeted treatment options based on their unique genomic profiles.
“This access is the driving motivation behind the extensive work we do with pharma partners to help connect the right patients to new therapies as soon as they are approved.”
The latest approval expands the clinical indications for the Oncomine Dx Target Test. It is now approved and reimbursed by insurers in 19 countries, including the US, Japan, South Korea, and across Europe and the Middle East.
Following this approval, the American biotechnology firm and Servier Pharmaceuticals will continue collaborating on additional companion diagnostics using the Ion Torrent Oncomine Dx Express Test.
Available on the Ion Torrent Genexus Dx System, this test can deliver results in as little as one day. This speeds up the matching of patients with optimal treatments based on their genomic profiles.
