FRAMINGHAM, MA — BERG, a clinical-stage biotech that employs patient biology and artificial intelligence (AI) to research diseases and develop innovative treatments and diagnostics, recently announced the publication of a new study, entitled “Clinical utility of a serum biomarker panel in distinguishing prostate cancer from benign prostate hyperplasia [BPH]” in Scientific Reports.

As part of the study, BERG evaluated over 750 patients at geographically diverse medical centers in the U.S. and Canada, where they applied the biomarker panel, comprised of filamin-A (FLNA), age and prostate volume, to predict and stratify men with BPH from those with PCa.

The findings prompted a better predictive performance than PSA alone, showcasing the use of the biomarker panel prior to biopsy helps:

• enhance clinical decision support for those who may receive a biopsy
• reduce the need for biopsy and unnecessary harm, e.g., impotence, infections and psychosocial effects
• prevent more false negative tests in the more aggressive forms of prostate cancer
• provide doctors and patients a better tool to manage cases of active surveillance

“Prostate cancer is regarded as one of the leading causes of cancer deaths in men,” said Dr. Niven Narain, CEO, President and Co-founder of BERG. “Our use of BERG’s Interrogative Biology® platform has enabled us to develop the first AI blood-based biomarker for disease diagnosis in managing both prostate cancer and BPH diagnosis. Our intent is that by enhancing clinical decision support that we will be able to establish a more efficient treatment paradigm and potentially reduce fiscal burden to healthcare systems around the world.”

Prostate cancer is an important public health problem, and there is a significant unmet need for accurate diagnostic testing. Traditionally, the first-line method to screen for the disease begins with PSA blood test followed by a digital rectal examination and prostate biopsy. From 2006-2009, Medicare spent $450 million annually on PSA screening and subsequent diagnostic procedures with a third of total Medicare spending, $145M annually, allocated to screening men over 75 years of age, a population least likely to benefit from this form of testing. The rate and incidence of prostate cancer is forecast to consistently increase and total market size of the prostate cancer diagnostics is over $2.8BN with a forecast increase of 13.2% CAGR up to 2027.

The study was conducted in collaboration with the Center for Prostate Disease Research, John P. Murtha Cancer Center Research Program, Department of Surgery, Uniformed Services University of the Health Sciences and the Walter Reed National Military Medical Center in Bethesda, MD, Henry M Jackson Foundation for the Advancement of Military Medicine in Bethesda, MD, University Health Network in Toronto, Canada, Department of Laboratory Medicine and Pathology at Harvard Medical School and Boston Children’s Hospital in Boston, MA, Mount Sinai Hospital in Toronto, Canada, Department of Clinical Medicine at University of Oxford in Oxford, UK, Center for Integrated Research in Cancer and Lifestyle, Cedar-Sinai in Los Angeles, CA and Durham VA Medical Center in Durham, NC.

BERG would like to thank the patients and families who participated in our research studies and also dedicate this body of work and publication to the late, Colonel David G. Mcleod, MD, JD, MC whose vision and mentorship was the driving force of the joint research with BERG and DoD.

About BERG
BERG LLC is a clinical-stage, artificial intelligence-powered biotech leveraging its proprietary platform, Interrogative Biology®, to map disease and revolutionize treatments across oncology, neurology and rare diseases. By taking a Back to Biology™ approach, BERG is able to identify critical biomarkers that can accelerate the discovery and development of treatments aimed at the most promising therapeutic targets and pathways. BERG has leveraged both Interrogative Biology® and traditional R&D methods to develop a robust pipeline of first-in-class product candidates and diagnostics that advance bold innovations that have the potential to improve patient lives. To learn more about how we’re enabling bold innovation, visit berghealth.com.

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