Agios Pharma Shares Rise as FDA Grants Breakthrough Status to Thermo Fisher's Glioma Test

Shares in Agios Pharma experienced an uptick after the FDA awarded breakthrough status to a companion diagnostic for vorasidenib, Agios' experimental drug targeting brain cancer. This diagnostic test, part of Thermo Fisher’s Oncomine Precision Assay, identifies isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations, crucial for determining patient eligibility for targeted therapies with a quick turnaround.

Thermo Fisher and Agios have solidified their collaboration to co-develop this diagnostic for vorasidenib (AG-881), an IDH 1 and 2 inhibitor currently in the phase 3 INDIGO trial for low-grade glioma. Despite previous patient recruitment challenges due to the coronavirus pandemic, Agios presented promising phase 1 trial data at the ASCO congress, demonstrating vorasidenib's ability to penetrate the central nervous system and reduce a biomarker for IDH activity in brain tumours.

The Oncomine assay, initially launched as a research tool, is now being developed alongside vorasidenib, aiming for FDA approval as a clinical diagnostic for IDH1 and IDH2 mutations in low-grade glioma patients. This test is designed for Thermo Fisher’s Ion Torrent Genexus System, a next-generation sequencing (NGS) machine capable of delivering genomic profiling results in a single day, significantly faster than traditional methods.

With an estimated 70% of cancer drugs in development being targeted therapies, the importance of genome profiling in identifying specific disease-causing mutations is paramount. Thermo Fisher plans to seek approval for the Oncomine assay as a companion diagnostic for multiple therapies, targeting a wide range of mutations across various cancer types, including lung cancer through liquid biopsy or blood sample tumour profiling.