Dr. Gregg has more than 30 years of relevant experience and remarkable achievements in the medical device and diagnostics industries.
Sarasota, FL (PRWEB) August 04, 2015
RPS Diagnostics (RPS®) – a developer, manufacturer, and marketer of rapid point-of-care (POC) diagnostic tests – today announced that Robert A. Gregg, PhD, has joined RPS as Senior Vice President of Clinical and Regulatory Affairs. Dr. Gregg has more than 30 years of relevant experience and remarkable achievements in the medical device and diagnostics industries.
“Bob not only brings a wealth of regulatory experience but has the proven ability to overcome regulatory barriers to facilitate landmark FDA clearances, such as getting a rapid HIV test approved for over-the-counter home-use,” said Robert Sambursky, MD, chief executive officer and president of RPS. “His inside knowledge of the FDA as a former reviewer combined with his scientific knowledge and experience with product development, makes him the ideal person to usher RPS’s disruptive technologies through the regulatory process in the most timely and efficient manner.”
Prior to joining RPS Diagnostics, Gregg led Regulatory and Quality Affairs at Siemens Healthcare Diagnostics, Leica Biosystems, and OraSure Technologies, Inc. While at OraSure, Gregg earned the first ever over-the-counter status designation for a rapid HIV test. Gregg also served as Vice President of Corporate Regulatory Affairs and Quality Systems at PerkinElmer, Inc. Earlier at Roche Diagnostics, Gregg served as the Director of Regulatory Affairs and was responsible for multiple business units including immunology-based technologies in the areas of infectious diseases, microbiology, and clinical chemistries. Preceding his time at Roche, Gregg was the Executive Director of Regulatory Affairs and Quality Assurance at the Direct Access Diagnostics division of Johnson & Johnson, where he led the approval of the first HIV home collection test kit. The foundation to Gregg’s accomplished career stems from his former role as a Biologist and Senior Staff Fellow at the U.S. Food and Drug and Administration. Gregg received his PhD in Biology from Georgetown University and a BA in Biology and Chemistry from College of St. Rose.
Founded in 2004, RPS Diagnostics (RPS) is an emerging developer, manufacturer, and marketer of rapid point-of-care (POC) diagnostic tests. RPS Diagnostics is a trade name of Rapid Pathogen Screening, Inc., a wholly owned subsidiary of RPS Diagnostics, Inc. The company’s innovative and patented technology platform facilitates the development of a spectrum of cost-effective tests to support the rapid, in-office diagnosis of patients with infectious diseases and inflammatory conditions. As a result of U.S. government contracts, this platform is also being developed to help detect the body’s immune response to viral and bacterial infections as well as chemical nerve agent blood toxins. RPS tests have high sensitivity and specificity, and can be easily performed by a clinician or their staff without extensive training or additional equipment. Currently available RPS tests include AdenoPlus® to aid in the diagnosis of Adenoviral conjunctivitis (pink eye) and InflammaDry® to aid in the diagnosis of dry eye disease. The FebriDx™ test to assess the clinical significance of an acute febrile respiratory infection and aid the differentiation of viral or bacterial etiology is CE marked and is available in Europe as well as other countries that accept the CE mark. At this time, the FebriDx test has not received U.S. Food and Drug Administration (FDA) clearance and is not commercially available in the United States. For more information on RPS and its products, visit RPSdetectors.com.
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Media contact: Laura Lovejoy • laura(at)saranova(dot)net • 941.928.9025