Metabolon Identifies Biomarkers with Superior Diagnostic Performance Over Creatinine for Chronic Kidney Disease
- Data presented at National Kidney Foundation 2016 Spring Clinical Meetings
- Metabolites form basis of accuGFR™ test in development
RESEARCH TRIANGLE PARK, N.C. – April 28, 2016 – Metabolon, Inc., the global leader in metabolomics, presented results at the National Kidney Foundation 2016 Spring Clinical Meetings from a study that identified metabolite markers of glomerular filtration rate (GFR) with superior diagnostic performance over creatinine. These biomarkers form the basis of its accuGFR™ test, which the company is developing and clinically validating as an improved test to aid in classifying chronic kidney disease (CKD).
Why the Need for a New GFR 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.
“Because there is such a high error rate in eGFR results, up to 10 million out of the 26 million U.S. patients with CKD may have their disease stage incorrectly classified,” said Regis Perichon, Ph.D., Director of New Product Development, Precision Medicine at Metabolon. “Compared to the standard-of-care equation, MDRD (Modification of Diet in Renal Disease), novel metabolite-based equations for estimating GFR show significant improvements in accuracy that would benefit more than two million patients.”
About Poster no. 284
The plasma levels of several metabolites, including creatinine and urea, were determined in a prospective cohort of 482 consecutive adult patients (48% male, 52% female; age: median 60.5, range 18-91 years) with known GFR (median 60, range 3-128 mL/min/1.73m2) determined by plasma iohexol clearance (mGFR).
Some metabolites displayed a higher correlation to measured GFR than creatinine (r2=0.70), e.g., pseudouridine (r2=0.84), acetylthreonine (r2=0.82), and acetylalanine (r2=0.77). The creatinine-based GFR estimating equation, IDMS-traceable MDRD, was used to estimate the GFR in the patients with known GFR. GFR estimating models using a few of the new metabolite markers, age and gender were constructed, with several displaying P20 and P30 (measures of precision) characteristics significantly superior to that of the MDRD equation.
These results suggest that a small set of metabolite compounds can provide a more precise estimate of GFR. This set of markers is under clinical validation as the accuGFR test.
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.
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 as a laboratory-developed test (LDT) based on 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. accuGFR requires only a single, fasted blood draw, which will make it easier for doctors to provide better care for their patients and give patients more confidence in their level of kidney function.
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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