Dive Brief:
- Thermo Fisher Scientific said Monday its assay to identify two mutations in patients with low-grade glioma, a type of brain tumor, has received FDA's breakthrough device designation. The test is being developed in partnership with Agios Pharmaceuticals as a companion diagnostic for vorasidenib (AG-881), an investigational dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) enzymes.
- Also this week, digital therapeutic developer MedRhythms said it gained breakthrough device status for a treatment to help stroke survivors with walking impairments.
- The two companies are among a fresh wave of new product hopefuls to announce FDA's backing for priority review during the past several weeks.
Dive Insight:
The latest burst of products to be accepted into the Breakthrough Devices Program pushes the total number to receive the designation beyond 300.
As the successor to FDA's Expedited Access Pathway, the Breakthrough Devices Program is intended to accelerate the review process for promising new treatments and diagnostics with additional feedback from the agency. Companies are not required to make their designations public but many choose to do so.
Thermo Fisher said it plans to eventually pursue premarket approval for the Oncomine Precision Assay as a companion diagnostic for multiple therapies and will also seek approval for liquid biopsy tumor profiling in lung cancer and solid tissue tumor profiling in multiple cancer types.
The assay is designed to run on the Ion Torrent Genexus System, an automated next-generation sequencing platform that can turn around genomic profiling results in one day. Launched in November 2019 for research applications, the sequencer has also been enabled to analyze SARS-CoV-2 samples to support epidemiology or contact tracing studies.
Thermo Fisher said its assay is expected to aid detection of a range of biomarkers, including EGFR, ALK, KRAS, BRAF, ROS1, NTRK, RET, HER2 and others. Agios' vorasidenib is currently being studied in the Phase 3 INDIGO study for IDH mutant low-grade glioma.
MedRhythms' digital therapeutic to address walking deficits in chronic stroke patients works by stimulating the neural circuits that control movement. The device is being studied in a randomized controlled clinical trial at five rehabilitation hospitals and research centers.
Other companies announcing breakthrough device designations from FDA in recent weeks include:
GTX medical, for an implantable device called Go-2 intended to aid recovery of leg motor function in spinal cord injury patients through targeted epidural stimulation to reconnect the brain with paralyzed muscles.
Nuvaira, for a lung denervation system designed to disrupt pulmonary nerve input to reduce the risk of COPD exacerbation.
Laminate Medical Technologies, for its VasQ device designed to support the creation of arteriovenous fistulas in hemodialysis patients.
Noctrix Health, for its wearable NTX100 neuromodulation treatment for adults with restless leg syndrome.
Rhaeos, for FlowSense, a noninvasive thermal sensor for monitoring ventricular shunt function in patients with excess cerebrospinal fluid caused by hydrocephalus.
Epineuron Technologies, for its device that provides electrical stimulation to promote the regeneration of peripheral nerves.
