DURHAM, N.C., Sept. 25, 2020 /PRNewswire/ -- Predigen Inc., a privately held diagnostic company and emerging leader in precision medicine, spun-out from Duke University, announced today a study published in The Lancet Infectious Diseases identifying biomarkers that detect viral infections before clinical disease develops. These findings, stemming from work performed by Duke Health scientists, could form the basis of novel approaches for early diagnosis, treatment and management of emerging viral outbreaks and pandemics.
"The study is exciting because, currently, there is no reliable way to identify pre-symptomatic patients," said Ephraim Tsalik, M.D., Ph.D., Predigen's chief science officer and co-founder, and a clinical investigator of this study. "Early diagnosis can lead to earlier, more effective therapy as well as quarantine before someone can spread the infection to others. Predigen's team of physician-scientists at Duke University used machine learning to discover these molecular signatures, representing a more rapid and accurate means to predict, diagnose and manage disease. Especially in light of the challenges posed by COVID-19, these results offer hope for new solutions."
According to the authors of this five-year study involving 1465 participants, these findings are the first to validate, in a real-world setting, that a blood-based, host gene expression test can accurately predict respiratory viral infection before typical symptoms are present.
For years, Tsalik and colleagues in the Duke Center for Applied Genomics and Precision Medicine have focused on developing innovative tests to diagnose infectious diseases such as sepsis, fungal infection, and most notably, to distinguish between viral and bacterial infections. The ability to discriminate these various causes of illness can help reduce the unnecessary use of antibiotics, a major cause of antibiotic resistance. Predigen has licensed the intellectual property for the company's viral signature, referred to as HR-PreV (Host Response – PreViral).
With testing solutions that assess the immune response to stress and disease, Predigen is collaborating with Biomeme, Inc. to deliver host response tests to the point-of-need. Applying Predigen's tests to Biomeme's "PCR anywhere" platform will deliver a better diagnostic methodology (host response signatures) for use in a wide variety of settings that are more accessible to patients.
About the Science
Predigen's scientists from Duke University focused on gene expression, which is a measure of how active or inactive a gene may be in a given situation. By looking at the expression of tens of thousands of genes, the team used machine learning to discover patterns (or signatures) in that data. They found a gene expression signature indicating the presence of a bacterial infection and another signature for viral infection. However, there were no readily available technologies that could measure these biomarkers in a simple and rapid format. To address this need, Predigen formed a partnership with Biomeme, tapping into their 27-target, multiplex, quantitative, RT-PCR assay, which delivers results in about 60 minutes. The signatures and interpretive algorithms have been combined into a point-of-need prototype utilizing Biomeme's Franklin™ thermocycler and its companion mobile app.
"Predigen's tests focus on the host response, which is itself a molecular measurement of health and disease," said Tsalik. "As such, our tests have been shown to be very accurate and have potential to provide valuable information to inform healthcare providers' management of patients. It has long been clear that tests to reliably distinguish bacterial and viral infections simply don't exist on the market. Moving forward, Predigen will focus on translating its successful research to real-world utilization of its tests by physicians, delivering innovative testing solutions to the point of need."
Predigen, Inc. is a global leader in the development of host gene expression signatures for use as prognostic, diagnostic, and therapeutic monitoring tools. Predigen is devoted to advancing the diagnostics field in areas of high unmet need, including infectious disease, cardiovascular disease, autoimmune and inflammatory disease, cancer and drug response. For more information on Predigen, please visit the company's website at www.predigen.com.