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Metabolon to Develop accuGFR Kidney Function Test with Johns Hopkins and Tufts Medical Center

06/02/16

Metabolon to Develop accuGFR™ Kidney Function Test with Johns Hopkins and Tufts Medical Center

  • More accurate kidney function test needed for chronic kidney disease
  • “Silent killer” can go undetected without symptoms until patient has lost 90 percent of kidney function

RESEARCH TRIANGLE PARK, N.C. – June 2, 2016 – Metabolon, Inc., the global leader in metabolomics, announced today that it has entered into an agreement with Johns Hopkins University and Tufts Medical Center to develop accuGFR™ as an improved diagnostic test for determining glomerular filtration rate (GFR) to aid in diagnosing chronic kidney disease (CKD). Experts at the three organizations will work together with the goal to produce accuGFR as a more accurate and precise test for the assessment of kidney function. The test will require only a single, fasted blood draw, making it easier for doctors to provide better care for their patients and give patients more confidence in their level of kidney function.

“We’re honored to work with leading international kidney experts Andrew Levey, MD, and Lesley Inker, MD, at Tufts Medical Center and Josef Coresh, MD, PhD, at Johns Hopkins to develop accuGFR,” said John Ryals, PhD, CEO at Metabolon. “As recognized authorities in medical practice, epidemiology and outcomes related to chronic kidney disease, they will provide invaluable clinical insight throughout the process. 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.”

Why the Need for a New Test?
According to the National Kidney Foundation, GFR is the best estimate of kidney function. Determining the measured GFR (mGFR), however, is a complex, invasive and expensive procedure that requires continuous intravenous infusion of a kidney filtration marker and multiple, precisely timed blood and urine collections. Despite being the gold standard for assessing kidney function, the complexity of the mGFR procedure makes it impractical for routine clinical practice.

In routine clinical practice, GFR is estimated (eGFR) using creatinine as a marker of kidney filtration. Creatinine-based methodologies for eGFR are easy to use, but are imprecise with significant rates of large errors. Only about two-thirds of eGFR results are within 20 percent of the patient’s mGFR. As a result, patients may be misdiagnosed or the severity of their disease underappreciated, which leads to sub-optimal treatment of their condition. 

In collaboration with Johns Hopkins and Tufts Medical Center, Metabolon has evaluated hundreds of patient samples using its advanced metabolomics technology to verify the clinical utility of novel metabolite markers of kidney function. These applied metabolomics biomarkers form the basis of the accuGFR test, which is being developed and clinically validated against the gold-standard mGFR. In addition, the latest development study results indicate that accuGFR has great potential to provide clinical value beyond existing standard-of-care methodologies. 

About Chronic Kidney Disease
Today, 10 percent of the worldwide population has some form of CKD, and millions die each year from its complications. Known as a “silent killer,” CKD can go undetected without signs or symptoms until a person has lost 90 percent of their kidney function. The World Health Organization predicts that the prevalence of CKD will increase nearly 20 percent in the next decade, making it a global public health issue.

About Metabolon
Metabolon, Inc. is the world’s leading health technology company focused on the use of metabolomics in precision medicine. This powerful tool for assessing health is based on proprietary platforms and informatics that deliver biomarker discoveries, innovative diagnostic tests, and ground-breaking partnerships in genomics-based health initiatives. Metabolon’s expertise is also accelerating research and product development across the pharmaceutical, biotechnology, consumer products, agriculture and nutrition industries, as well as academic and government organizations. Founded in 2000 and headquartered in Research Triangle Park, North Carolina, the company has conducted more than 5,000 independent and collaborative studies, resulting in over 550 peer-reviewed publications. For more information, please visit www.metabolon.com or follow us on LinkedIn or Twitter.

Cautionary Note about Forward-Looking Statements
The materials provided herein that are not historical facts are or might constitute projections and other forward-looking statements regarding future events that involve substantial risks, uncertainties and assumptions. If any of these risks or uncertainties materialize, or if any of these assumptions prove to be incorrect, Metabolon’s results could differ materially from the results expressed or implied by any forward-looking statements. The risks, uncertainties and assumptions referred to above include, but are not limited to: the uncertainties inherent in biochemical research and development; decisions by regulatory authorities regarding whether and when to approve diagnostic tests; the clinical utility of Metabolon’s metabolomic services; Metabolon’s and its distributors’ ability to successfully commercialize and market both new and existing products; governmental laws and regulations affecting health care, including access, pricing and reimbursement of diagnostic tests; the strength of Metabolon’s intellectual property portfolio; Metabolon’s history of operating losses; whether Metabolon is able to achieve or sustain profitability; its highly competitive industry; its ability to compete effectively; security and privacy risks; and Metabolon’s ability to continue to innovate and provide products and services that are useful to its clients, among other risks, uncertainties and assumptions.

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Contact:
Robin Fastenau
Vice President, Corporate Communications & Investor Relations
Metabolon, Inc.
rfastenau@metabolon.com
919.595.2201