BERG Broadens Relationship with Department Of Defense (DoD) Center For Prostate Disease Research with New Predictive Biomarker Test for Prostate Cancer

New Clinical Evidence Guided by Artificial Intelligence that Could Significantly Enhance Prostate Cancer Detection and Reduce Over-Diagnosis and Unnecessary Treatments in Benign Prostate Hyperplasia Patients arises from Research Collaboration with BERG and the Center for Prostate Disease (CPDR) in the Department of Surgery, Uniformed Services University (USU)

BOSTON — BERG, a biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced the completion of clinical validation for a new predictive diagnostic test that can improve detection of prostate cancer. The new test can minimize unnecessary biopsies to distinguish men with prostate cancer compared to those with benign prostate hyperplasia (BPH). This new development is the result of BERG’s long-standing Cooperative Research and Development Agreement (CRADA) with the DoD and USU’s Center for Prostate Disease Research that was initiated in late 2013 to develop novel cancer diagnostics. Since its inception, this innovative collaboration has pushed the boundaries of drug target discovery and diagnostics by taking a data-driven approach with the goal of significantly accelerating how clinicians will be able to detect, diagnose and treat cancers. The new prostate diagnostic test will be the first clinical commercial product in the world to be developed with the use of artificial intelligence (AI).

“We are proud of the clinical validation that we have achieved resulting from our collaboration with the DoD, and we are very excited about this new diagnostic test that has the potential to enhance the current approach to prostate cancer screening and detection,” and said Niven R. Narain, BERG Co-Founder, President and Chief Executive Officer of BERG. “BERG’s ongoing collaboration with CPDR has greatly helped advance our clinical validation that will benefit patients in need, and we look forward to expanding our work to further evaluate the clinical benefits of this new biomarker test. This has been a remarkable government-industry collaboration.”

Prostate cancer is one of the leading causes of cancer deaths in American men, and there is a significant unmet need for accurate diagnostic testing.1 Traditionally, the first-line method to screen for the disease begins with a prostate-specific antigen (PSA) blood test followed by a digital rectal examination and prostate biopsy. Further, continued use of the PSA test and prostate biopsy places a heavy burden on the patient and healthcare system with over-diagnosis, unnecessary biopsies and increased costs. From 2006-2009, Medicare spent $450 million annually on PSA screening and subsequent diagnostic procedures.2

BERG’s new diagnostic test addresses this issue and provides an alternative for clinicians that is more accurate and less invasive. BERG recently published data in the Journal of Molecular Biomarkers & Diagnosis (February 2017, https://www.omicsonline.org/open-access/clinical-validation-of-a-serum-protein-panel-flna-flnb-and-krt19-for-diagnosisof-prostate-cancer-2155-9929-1000323.pdf ) demonstrating that their novel serum protein panel of prostate cancer biomarkers, Filamin A and Keratin-19 (FLNA and KRT19) could be used to complement traditional PSA testing for population screening, and could accurately discriminate between prostate cancer and benign prostate hyperplasia. BERG has also published results in Future Science OA (December 2016, http://www.future-science.com/doi/pdf/10.4155/fsoa-2016-0065 ) that described the protein panel through identification of disease-specific biomarkers through a Bayesian learning methodology.

BERG, in collaboration with the CPDR, evaluated a valuable clinical cohort that demonstrated the utility of the prostate cancer panel in the BPH population. “Analysis of CPDR’s cohort demonstrated the value of BERG’s prostate test in preventing unnecessary biopsies in a patient population that critically needs better tools to assist with treatment decisions,” said Michael Kiebish PhD, Chief Precision Medicine Officer of BERG, who led Berg’s prostate cancer efforts, “The development of this new diagnostic test guided by BERG’s AI technology, helped provide fundamental insight to help improve patient care and prevent overtreatment.”

“In the continued research collaboration between BERG and CPDR, we are working together to identify and develop new diagnostic tests that have the potential to significantly improve the quality of patients’ lives,” said Army Major General (Ret.) Elder Granger, MD and BERG board director. “We are proud of the clinical evidence that has shown improvement in the detection of prostate cancer over standard tests in current use, and in turn, we aim to reduce the frequency of biopsies, and significantly cut down on over-diagnosis and unnecessary overtreatment, which could put patients at unnecessary risk.”

“Prostate Cancer is one of the most prevalent cancers in men, but current predictive tests have their limitations, exposing a significant unmet need for more accurate detection, especially for benign disease, where unnecessary diagnostic work up could be costly, and may also have a negative impact on the patient,” said Albert Dobi, Ph.D., Associate Director, Basic Science Research Program, CPDR.

About BERG
BERG is a clinical-stage company disrupting and re-defining the approach to drug discovery, research and development through its Interrogative Biology® platform. Its platform identifies therapies and biomarkers by applying algorithm- and probability-based artificial intelligence to analyze large numbers of patients’ genotypic, phenotypic and other characteristics. BERG’s platform operates at the intersection of biology, technology and artificial intelligence analytics and integrates many data characteristics regarding patients’ lifestyles, demographics and biology. BERG believes this allows the company to better understand patients’ disease profiles and consequently to identify and reveal molecular signatures to guide and accelerate product candidate selection and development. By identifying biomarkers and patient characteristics that are unique to the disease state, BERG is able to identify novel therapeutic product candidates and develop companion diagnostics to enhance specificity in its drug development process. BERG has leveraged its Interrogative Biology® platform to develop a robust pipeline of therapeutic product candidates and diagnostics in cancer, diabetes and neurology.

For additional information, please visit www.BERGhealth.com.

About USU
The Uniformed Services University of the Health Sciences (www.usuhs.edu) is the nation’s federal health sciences university. USU students are primarily active duty uniformed officers in the Army, Navy, Air Force and Public Health Service received specialized education in tropical and infectious diseases, preventive medicine, traumatic brain injury and posttraumatic stress, disaster response and humanitarian assistance, and acute trauma. USU’s Center for Prostate Disease Research is a state-of-the-art translational research program that studies prostate cancer and prostate disease in the Military Healthcare System. Since its inception in 1992, the center has developed a comprehensive prostate cancer database within the DoD, with approximately 28,000 prostate subjects enrolled to date. The CPDR is a leading prostate cancer research center credited with ground-breaking discoveries; and a prostate cancer clinical trials center at Walter Reed National Military Medical Center.

For more information, visit www.cpdr.org.

Disclaimer: The views expressed in this release are those of the author and do not reflect the official policy of the Department of Army, Navy, Air Force, Department of Defense, or U.S. Government. The identification of specific products, scientific instrumentation, or organization is considered an integral part of the scientific endeavor and does not constitute endorsement or implied endorsement on the part of the authors, DoD, or any component agency.

  1. American Cancer Society, Key Statistics of Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
  2. Cancer Volume 120, Issue 1, 1 January 2014, Pages 96–102 http://onlinelibrary.wiley.com/doi/10.1002/cncr.28373/abstract;jsessionid=3569D485D576F798265345E8C7E8F59B.f03t01

Media Contact:
Tola St. Matthew-Daniel
212-880-5385
BERG@ogilvy.com

Investor Contact:
Christina Tartaglia
Stern Investor Relations, Inc.
212-362-1200
christina@sternir.com