BIOLYTICAL REPORTS MILESTONE PATIENT ENROLLMENT IN NEW TRIAL FOR INSTIT, 60-SECOND RAPID HIV TEST
VANCOUVER, BC, October 16, 2007 - bioLytical Laboratories (bioLytical) today announced patient enrolment has exceeded 30% 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.
Initial patient enrolment began July 31, 2007. As of October 15, 755 patients were enrolled, representing over 30 percent of the total enrolment. To date, 11 clinical testing sites are involved in the study and are actively enrolling patients.
"The rapid pace of enrollment clearly reflects strong interest by investigators and patients," commented Rick Galli, Chief Technical Officer at bioLytical. "Timely site activation has also accelerated our ability to register new patients. We look forward to completing the study and substantiating for the FDA the safety and efficacy of INSTIT."
Patient enrolment is expected to continue until December 2007 and include approximately 2500 patients of known and unknown HIV status in total. This multi-centre, cross-country study will include up to 15 clinical sites and one central laboratory. bioLytical has contracted with Beardsworth Consulting Group Inc. in Flemington, NJ, as the Contract Research Organization for this study.
bioLytical is a Canadian company that has developed the INSTIT Rapid Antibody Test. INSTIT 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. INSTIT is also approved for HIV Type 2 detection in a number of other international countries, including Europe, and is pending similar approval in Canada. The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, physicians' offices and any other primary care facility as a screening assay capable of providing test results in less than 60 seconds.
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. INSTIT 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 INSTIT, 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.
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Media Contact for bioLytical Laboratories:
Amanda Smith, BSc.
Smith Biotech
Phone: (778) 846-4116
amanda@smithbiotech.com
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