The US Food and Drug Administration (FDA) has granted approval to the MediBeacon Transdermal GFR (TGFR) system for evaluating kidney function in individuals with normal or impaired renal function.
The system includes a TGFR monitor, a Lumitrace (relmapirazin) injection, and a TGFR sensor.
Lumitrace is a non-radioactive, non-iodinated fluorescent tracer agent administered intravenously and its clearance rate from the body is measured to assess kidney function.
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Attached to the skin, the TGFR sensor records Lumitrace fluorescence intensity transdermally, taking 2.5 readings per second. The TGFR Monitor then displays the average tGFR reading for the session.
Validated for use in evaluating glomerular filtration rate (GFR) in individuals with stable kidney function, the system leverages Lumitrace injection without requiring blood draws or urine tests, in contrast to existing approaches.
The current method for assessing measured GFR (mGFR) involves sophisticated laboratory analysis that takes place away from the individuals’ point of care, the company noted.
Designed for use across the adult population, the transdermal GFR (tGFR) method does not require input based on weight, gender, ethnicity, age, race or sex.
In line with the agreement with the FDA, the TGFR met its primary efficacy endpoint by showing a 94% P30 value, with participants representing a broad range of GFR values and skin tones.
P30 refers to the percentage of GFR estimates that fall within +/- 30% of the mGFR values.
MediBeacon CEO Steve Hanley said: “The approval of the TGFR by the FDA demonstrates our proprietary system can provide an effective option for assessing kidney function. According to the National Kidney Foundation, CKD causes more deaths each year than breast cancer or prostate cancer. It is an under-recognised public health crisis.
“The potential applications for the TGFR are numerous, and we look forward to exploring them with clinicians both in the hospital and outpatient settings.”
