Metabolon delivers actionable information to help clinicians to get ahead of important diseases where diagnosis, prevention and treatment are most effective and change the outcomes.We are using our unique metabolomics technology to develop new clinical tests as part of our Precision Medicine product offerings. Our pipeline of laboratory-developed tests (LDTs) has the potential for regulatory registration in the future.
accuGFR™: A More Accurate & Precise Test of Kidney Function
accuGFR is being developed as a more accurate and precise test of kidney function to aid in the diagnosis and staging of chronic kidney disease (CKD). The test uses a single, fasted blood draw to measure four metabolites and provide clinicians with an easy means to precisely determine their patients’ level of kidney function. accuGFR may be used for the quantitative determination of glomerular filtration rate (GFR) in serum to aid in the diagnosis and management of renal diseases.
Today, 10 percent of the world’s 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.
Providing Clinical Value Beyond Existing Tests
Approximately 200 million serum creatinine tests are done each year in the U.S. to provide estimates of glomerular filtration rate (eGFR) as a measure of kidney function. However, only about two-thirds of eGFR results are within 20 percent of the patient’s measured GFR (mGFR, the gold standard method). While mGFR is the most accurate procedure for determining GFR, it is a complex, invasive and expensive procedure with limited patient access.
In large studies conducted so far, accuGFR has shown to be more precise and accurate than the standards of care eGFR methodologies based on creatinine or cystatin C (MDRD and CKD-EPI equations). We believe that the superior precision of accuGFR and the fact that it does not require demographic variables has great potential to provide, on a global basis, clinical value beyond MDRD.
Non-alcoholic steatohepatitis (NASH) test
Non-alcoholic fatty liver disease (NAFLD) is one of the most prevalent chronic conditions in the U.S. Non-alcoholic steatohepatitis (NASH) is a more advanced, serious form of liver disease and has a prevalence of 3 to 5 percent in the general U.S. population. NASH not only involves excess fat accumulation in the liver, but also chronic inflammation that may lead to progressive hepatic fibrosis (scarring of the liver tissue). This, in turn, can lead to cirrhosis, liver failure and death.
Being able to identify whether a patient with suspected or confirmed liver disease has NASH or not, and/or what level of liver fibrosis the patient has, would provide new ways to manage and control this condition, especially as new drugs and treatment options become commercially available.
Global Health Assessment
Clinicians are all familiar with metabolites such as cholesterol, glucose and creatinine. In fact, there are a limited number of metabolites routinely measured in clinical practice. But, what if you could measure hundreds of metabolites from a single sample?
We are developing a comprehensive health assessment product to guide diagnostic and life-long clinical management decisions. This all-in-one panel aims to screen key metabolites that reflect a patient’s health across many areas, such as cardiovascular, kidney and liver health, macronutrient balance, metabolic age, microbiome balance, and diabetes, oxidative stress and inflammatory markers. Our team is currently working with key health innovators and healthcare providers to develop the test.
In addition to wellness screening, there are 60 million cases of undiagnosed disease in the U.S. and Europe, and 350 million cases worldwide. Undiagnosed and difficult to diagnose diseases, such as chronic fatigue syndrome, represent a large and expensive medical challenge. We see enormous opportunity to address the needs of clinicians and patients by applying our wide metabolic screening to this formidable diagnostic process.
To learn more about our growing diagnostics pipeline, contact us.