VANCOUVER, BC, July 31, 2007 - bioLytical Laboratories (bioLytical) today announced the first 25 patients have been enrolled in their Investigational Device Exemption (IDE) study for approval by the U.S. Food and Drug Administration (FDA) of INSTIT, a 60-second rapid HIV test for point-of-care (POC) testing. bioLytical's IDE filing was accepted by the FDA July 6, 2007.
bioLytical is a Canadian company that has developed the INSTI HIV-1 Rapid Antibody Test. INSTI is a rapid, in-vitro, qualitative test for the detection of antibodies to Human Immunodeficiency Virus (HIV) Type 1 in human whole blood, serum or plasma. The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices as a screening assay capable of providing test results in less than 60 seconds.
"INSTI has the ability to provide a fast and simple approach to HIV testing," comments Rick Galli, Chief Technical Officer at bioLytical. "Performance data from this study will determine INSTI's overall safety and efficacy."
The US Center for Disease Control estimates that approximately 40,000 persons in the United States become infected with HIV each year. Of those, 25 percent are unaware of their infection and could be spreading the disease unknowingly. Each year up to 22 million persons in the US are tested for HIV. With current revisions to both CDC and WHO guidelines on HIV testing advocating routine HIV screening as part of regular medical practice, the market for rapid HIV tests in the US will continue to escalate.
Rapid HIV antibody tests seek to improve access to HIV testing however, most must be administered in a clinical setting. Currently available rapid tests also have longer response times that can be a deterrent for many who should be tested. INSTI has been developed to make it ideal for use in mobile and in-field scenarios allowing all communities access and social barriers to be removed.
ABOUT INSTI HIV-1 RAPID ANTIBODY TEST
The INSTI HIV-1 Rapid Antibody Test is a rapid, in-vitro, qualitative test for the detection of antibodies to Human Immunodeficiency Virus Type 1 in human whole blood, serum or plasma. The test is capable of providing results in 60-seconds and is intended for use as a screening assay by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices.
ABOUT BIOLYTICAL LABORATORIES
bioLytical Laboratories (Inc.) is a leading developer and manufacturer of diagnostic tests for global health care markets. bioLytical is a privately owned company with headquarters and a state-of-the-art manufacturing facility located in Richmond, British Columbia, with offices in United Kingdom and Uganda, Africa. For more information about bioLytical and INSTI, please visit www.biolytical.com/.
ABOUT BEARDSWORTH CONSULTING GROUP
Beardsworth Consulting Group, Inc. is a privately held Contract Research Organization based in Flemington, NJ, celebrating its 21st year. Beardsworth provides full service capabilities, including regulatory consulting, clinical monitoring, data management, biostatistics, medical writing and project management for clinical trials in Phases I - IV. This news release is not, and under no circumstances is to be construed as, an advertisement, solicitation or offering of securities of bioLytical Laboratories. The statements made in this news release may contain certain forward-looking statements that involve a number of risks and uncertainties. Actual events or results may differ from the Company's expectations.
Media Contact for bioLytical Laboratories:
Amanda Smith, BSc.
Phone: (778) 846-4116
"Reproduced with permission - bioLytical Laboratories"