NEW YORK, Dec. 15 /PRNewswire-FirstCall/ - Genesis Bioventures, Inc. announced today that its wholly-owned subsidiary, Biomedical Diagnostics, LLC (Biomedical) has retained a leading FDA regulatory consulting firm, Devices and Diagnostics Consulting Group, Inc. (DDCG) of Rockville, MD, for assistance with the planned regulatory developments of Biomedical’s Mammastatin Serum Assay (MSA).
DDCG provides in vitro diagnostic and medical device regulatory services for companies seeking FDA approval for their products. The company is composed of former FDA reviewers, inspectors, and management officials and is led by the company’s founder and president, Thomas M. Tsakeris.
Mr. Tsakeris has extensive qualifications in the FDA regulatory approval process. He served as Director of the FDA’s Division of Clinical Laboratory Devices (DCLD), Office of Device Evaluation and the Center for Devices and Radiological Health (CDRH), where he was responsible for the premarket scientific evaluation of clinical laboratory device applications. He was instrumental in developing the FDA’s role as part of the Health and Human Services implementation strategy for the Clinical Laboratory Improvement Act of 1988 (CLIA'88), and has held several other senior management positions at the FDA.
“We are very pleased to have this relationship with Mr. Tsakeris and his associates. They bring a wealth of key regulatory approval expertise and skill to our team as we implement our MSA technology plan,” said Jim Arthurs, president of Biomedical Diagnostics. “Their assistance in managing our FDA applications and regulatory approval process will be invaluable in expanding our scientific and commercial opportunities.”
“We are excited for Biomedical Diagnostics and the potential of their MSA technology,” commented Mr. Tsakeris. “We look forward to working with them as they move forward with their breast cancer diagnostic commercialization strategies.”
The MSA was initially developed at the University of Michigan Cancer Center. Biomedical holds the exclusive license through Genesis Bioventures for the MSA from the University for scientific and commercial development as a blood test to assess women’s health. In scientific correlation studies women who tested high with the MSA assay showed to have lower risk of breast cancer than women who tested low. The MSA test is currently available to physicians through ARUP Laboratories in Salt Lake City, UT and directly through Biomedical’s CLIA certified high-complexity reference laboratory, the highest level of CLIA certification required for all reference laboratories performing complex human diagnostic testing.
More information about Biomedical Diagnostics and the MSA test can be found at www.bio-diagnostics.com.
About Genesis Bioventures, Inc.
Genesis Bioventures, Inc. is a biomedical development corporation focusing on the development and marketing of novel diagnostics and therapeutics in oncology and neurodegenerative diseases.
Statements in this press release that are not strictly historical facts are “forward looking” statements (identified by the words “believe”, “estimate”, “project”, “expect” or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company’s products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company’s periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.
CONTACT: GBI Investor Relations: (604) 542-0820, gbi@gnsbio.com, www.gnsbio.com Experigen: (310) 443-4100, info@experigen.com, www.experigen.com Aurelius Consulting Group: (800) 644-6297, info@runonideas.com, www.runonideas.com
Genesis Bioventures, Inc.
CONTACT: GBI Investor Relations: (604) 542-0820, gbi@gnsbio.com,www.gnsbio.com; Experigen: (310) 443-4100, info@experigen.com,www.experigen.com; Aurelius Consulting Group: (800) 644-6297,info@runonideas.com, www.runonideas.com
