Donald A. Berry
OTraces, Inc.,an early stage cancer detection and surveillance company, announced today that Donald A. Berry, PhD has joined its Scientific Advisory Board. Dr. Berry is Professor of Biostatistics and Founding Chair of Quantitative Sciences at The University of Texas MD Anderson Cancer Center. Dr. Berry brings extensive cancer research innovation and policy experience including his work with the National Institutes of Health (NIH)'s National Cancer Institute (NCI) PDQ® Screening and Prevention Committee and Editorial Board. Dr. Berry has also worked closely with the FDA Center for Devices and Radiological Health (CDRH) to help them set rigorous scientific and quality standards while they encouraged the adoption of adaptive clinical trial designs and using a Bayesianapproach more generally. The approach continues to gain favor with regulators, pharmaceutical companies, and national and international clinical researchers.
OTraces' early cancer detection technology is showing promise in the early detection of minimal residual disease (MRD), as well as in diagnosing tumor progression and immune status in a blood test, non-invasively and in real-time. This has been demonstrated in blinded clinical trials at leading research institutions for both breast and prostate cancer. Additional research is being done to validate efficacy in lung cancer and melanoma.
Dr. Berry sees particular promise for the application of Bayesian methods in early cancer detection and the exploration of biomarkers that may signal the onset of tumor formation --- especially for non-small cell lung cancer (NSCLC) where OTraces' earlier pre-validation studies suggest high potential.
According to Dr. Berry: "Like everyone in cancer research I am interested in early detection and prevention. Finding cancer early is a challenging goal, but it is easy compared with showing that finding early is a net benefit for patients. Early detection can lead to cures. But it is associated with over-diagnosis and consequent overtreatment as well as with false positives.
"Demonstrating a benefit for early detection while minimizing harm is a daunting task. Bayesian modeling can help with both sides of this equation. With regard to OTraces technology, it is attractive from several points of view. And their initial clinical testing results are promising. I look forward to working with OTraces and helping them achieve their goals, including focusing on improving the health and well-being of all people."
"OTraces molecular diagnostics platform is unique," says Keith Lingenfelter, CEO and Founder of OTraces. "Our platform is directed towards early detection of potentially multiple cancers in an annual physical examination screening test at the lowest possible price, as well as monitoring cancer patients for disease progression and immune status."
About OTraces
OTraces has developed cancer blood test software technology that can boost the accuracy of proteomic and other tests to superior levels and can detect and measure cytokine activity in the tumor microenvironment (TME) and thereby achieve real-time diagnosis of tumor progression and immune status in vitro (in a lab test) and without biopsy (in vivo). OTraces technology offers superior active surveillance and screening test economics relative to ctDNA testing (circulating tumor DNA) and other known methods. OTraces' software is compatible with instrument and lab procedures already in common use across the globe, and, is suitable for lab development testing (LDT, not requiring regulatory approval) and scalable for high-volume screening applications where the pressure is high to reduce costs. These attributes will facilitate rapid commercialization. OTraces has filed extensive patents on math-, physics- and artificial intelligence-based, next generation cancer detection technologies.