Next-generation sequencing test approved as companion diagnostic for glioma patients
A next-generation sequencing (NGS) test has recently received FDA approval as a companion diagnostic (CDx) for patients with Grade 2 IDH-mutant glioma who are eligible for VORANIGO® (vorasidenib) tablets.
In a collaboration with Servier Pharmaceuticals (Suresnes, France), the world-leading life science service company, Thermo Fisher Scientific (MA, USA) have developed the ‘Ion Torrent™ Oncomine™ Dx Target test’ as a CDx for patients with Grade 2 isocitrate dehydrogenase (IDH)-mutant glioma. This clinical application has recently been approved by the U.S. FDA.
Gliomas are the most common malignant primary brain tumors found in adults. Around 20% have a mutation in IDH genes, which encode a group of essential enzymes involved in numerous major cellular processes, including metabolism, lipogenesis and redox regulation. IDH mutations create distinct patterns in cancer metabolism, cause epigenetic changes and contribute to treatment resistance, therefore it is crucial to test for these mutations to guide appropriate therapy decisions. It is recommended all patients with glioma undergo IDH mutation testing, as identifying the IDH mutation status in glioma patients is increasingly critical for accurate treatment.
You may also be interested in:
- Expanding the personalized medicine landscape to chronic diseases
- Biomarkers for oncology: an interview with Jialu Liu
- FDA approves companion diagnostic for hemophilia B gene therapy
In August 2024, Servier Pharmaceuticals’ VORANIGO tablets received FDA approval, marking the first targeted therapy for Grade 2 IDH-mutant glioma. It is an inhibitor of IDH1 and IDH2, suitable for treating adults and pediatric patients aged 12 and older with Grade 2 astrocytoma or oligodendroglioma harboring a susceptible IDH1 or IDH2 mutation, following surgery such as biopsy, sub-total resection or gross total resection.
“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,” commented David K Lee, Chief Executive Officer of Servier Pharmaceuticals.
NGS enables the sequencing of hundreds to thousands of genes simultaneously. Harnessing the power of NGS, the Oncomine Dx Target test can examine 46 cancer driver gene variants using one sample input. These driver gene mutations are key biomarkers linked to targeted oncology treatments. The test has previously been approved for use in non-small cell lung cancer, cholangiocarcinoma, medullary thyroid cancer and thyroid cancer. The recent inclusion of glioma represents a significant advancement in precision medicine.
“As the healthcare system works to realize 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,” elaborated Kathy Davy, President of Clinical NGS at Thermo Fisher Scientific.
This first FDA approval marks just the beginning of the partnership between Thermo Fisher Scientific and Servier Pharmaceuticals. The companies are already collaborating on another CDx that aims to deliver test results in just 1 day, a significant improvement over the already expediated current 4-day wait with Oncomine Dx Target. They hope to speed up the process of matching patients with the appropriate treatments based on their genomic profiles, offering alternative care approaches for patients with very few available treatment options.
