New Kidney Function Test to Be Developed by Metabolon and Partners Johns Hopkins, Tufts Medical Center

New Kidney Function Test to Be Developed by Metabolon and Partners Johns Hopkins, Tufts Medical Center

Metabolon, a North Carolina biotech company working on metabolomics in precision medicine, announced it will partner with Johns Hopkins University and Tufts Medical Center to develop accuGFR — an improved diagnostic test designed to assess glomerular filtration rate (GFR) to aid in the diagnosis of chronic kidney disease (CKD).

CKD is estimated to affect nearly 10 percent of the global population and millions pass every year due to CKD-related complications. Known as a “silent killer,” this kidney disease can go undetected until 90 percent of the kidney function has been irreversibly lost. The World Health Organization (WHO) predicts that the prevalence of CKD will increase to 20 percent in the next 10 years, becoming a global public health issue.

Experts from the three partners will cooperate to produce accuGFR as a more precise test for assessing kidney function. The test will be considerably easier to administer, needing only a single blood draw, which will help doctors provide better care for their patients and feel more confident in their diagnosis.

GFR is the best approximation of kidney function, according to the National Kidney Foundation. Evaluating the measured GFR (mGFR), however, is a complex process that requires invasive and costly procedures requiring continuous intravenous infusion of a kidney filtration marker — as well as multiple, precisely timed blood and urine collections.

Together with Johns Hopkins and Tufts Medical Center, Metabolon has evaluated several hundred patient samples using its metabolomics technology to verify the clinical utility of novel metabolite markers of kidney function. These biomarkers form the basis for the accuGFR test, which can potentially provide clinical value beyond the existing gold-standard methodologies.

Despite having earned the title of “gold standard” for evaluating kidney function, the complexity associated with mGFR makes it impractical for routine clinical practice, where the estimation of GFR (eGFR) is made using creatinine as a kidney filtration marker. Creatinine-based methods are easy to use but have imprecise results and significant rates of significant errors. Only about 66 percent of eGFR results are within 20 percent of patients’ mGFR. As a result, patients might receive misdiagnoses or have their disease severity underrepresented, potentially leading to sub-optimal treatment options.

Metabolon CEO John Ryals, Ph.D., said in a press release the company was honored to work with leading kidney experts Andrew Levey, M.D., and Lesley Inker, M.D., at Tufts Medical Center, and Josef Coresh, M.D., Ph.D., at Johns Hopkins to develop accuGFR.

“As recognized authorities in medical practice, epidemiology, and outcomes related to chronic kidney disease, they will provide invaluable clinical insight throughout the process,” Ryals said. “They have also agreed to use large, well-characterized and diverse patient cohorts to develop and validate the test and support its progress through additional clinical studies.”

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