TGFR is one of several products granted breakthrough status, FDA’s expedited path outlined in the 21st Century Cures Act. The product measures glomerular filtration rates (GFRs) in patients with impaired or normal renal function.
TGFR is considered a combination product and includes an optical skin sensor, monitor and MB-102, a proprietary fluorescent tracer agent that glows in the presence of light. The device is designed to provide clinicians continuous real-time measurement of GFR at the point of care with no need for blood sampling or urine collection.
According to MediBeacon, the ability to measure GFR is of high clinical interest, especially in patients with or at risk of kidney disease. Kidney disease is a hidden epidemic, affecting more than 850 million people worldwide, according to groups around the world combatting the disease. This is twice the number of people who have diabetes and more than 20 times the number of people with cancer.
Under the Breakthrough Devices program, a provision of the 21st Century Cures Act, the FDA works with companies to expedite regulatory review in order to give patients more timely access to diagnostic and therapeutic technologies. FDA evaluates products on several criteria: Devices must provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions, and they must also represent breakthrough technologies, have no approved or cleared alternatives, offer meaningful advantaged over existing technologies and be judged that its availability is in the best interest of patients.
FDA has granted this status to a few other companies this year as follows:
- MYnd Analytics for PEER (the Psychiatric EEG Evaluation Registry).
- Dtheras for its DTHR-ALZ Alzheimers Disease treatment.
- Polyganics for its liver and pancreas sealant
- AliveCor for its bloodless hyperkalemia test.
- Raydiant Oxymetry for its noninvasive prenatal oxygenation monitor.
- Roche for two Elecsys cerebrospinal fluid (CSF) Alzheimers Assays.
- Elio Plasma Resolve for its qualitative in vitro diagnostic that uses targeted high-throughput, parallel-sequencing technology to detect single nucleotide variants, small insertion/deletions, amplifications, rearrangements, and microsatellite instability (MSI) in a broad multigene panel, using circulating cell-free DNA isolated from plasma samples
According to FDA, TGFR is a product that has the potential to be more effective at diagnosing a life-threatening or irreversibly debilitating disease or condition compared to the current standard of care.