bioLytical Reports Milestone Patient Enrollment in New Trial for INSTITM, 60-Second Rapid HIV Test

Source: Marketwire.com

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Oct. 16, 2007) - bioLytical Laboratories (bioLytical) today announced patient enrollment has exceeded 30% in their Investigational Device Exemption (IDE) study for approval by the U.S. Food and Drug Administration (FDA) of INSTITM, 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 enrollment began July 31, 2007. As of October 15, 755 patients were enrolled, representing over 30 percent of the total enrollment. 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 INSTITM."

Patient enrollment 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 INSTITM Rapid Antibody Test. INSTITM 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. INSTITM 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. INSTITM 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.

Click here to read the press release