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bioLytical™ Laboratories Release: Health Canada Approves INSTI(TM) For HIV Testing In Doctors' Offices


11/7/2005 12:42:10 PM

RICHMOND, BC, Nov. 7 /PRNewswire/ - bioLytical(TM) Laboratories announced today, INSTI(TM) HIV, a rapid HIV test kit developed by the company, has received market approval from Health Canada. INSTI(TM) HIV is the only immediate detection kit available in Canada for use in a point-of-care setting such as a doctor's office, clinic or hospital.

"This is a tremendous advancement in the management of HIV," said Robert Mackie, CEO of bioLytical(TM) Laboratories. "A patient can now be tested for HIV in the comfort and privacy of their family doctor's office with just a finger prick of blood and receive results immediately. This significantly reduces the anxiety that is often caused by having to wait several days for test results to come back from the laboratory."

INSTI(TM) HIV is a highly effective and reliable test that detects the presence of antibodies to HIV (Human Immunodeficiency Viruses Type 1) in whole blood, serum or plasma in 60 seconds. It has a 99.6% accuracy rate, as demonstrated in extensive clinical trials carried out in multiple centers across Canada. To further ensure INSTI(TM) maintains its high quality, it is manufactured in Canada under strict controls in a state-of-the-art ISO accredited facility.

"We are very pleased with this approval since Health Canada's requirements for rapid HIV test kits are among the most stringent in the world," explained Rick Galli, Director of Research and Development for bioLytical(TM). "The clinical trials comprised more than 16,000 tests and over 3,400 patients in multiple centers in Vancouver, Toronto and Calgary, giving us considerable confidence in the quality, accuracy and reliability of INSTI(TM) HIV."

According to Public Health Agency of Canada, approximately 56,000 people have been confirmed as HIV positive in this country since 1985, but it is estimated that an additional 17,000 cases exist but have yet to be diagnosed. "It is our hope that the availability of a simple and convenient test like INSTI(TM) HIV will help reduce the number of cases that go undiagnosed," added Galli.

bioLytical(TM) has created the INSTI(TM) Foundation - a philanthropic arm of the biotech company - as part of the company's global commitment to helping those regions most affected by HIV. Through the use of a portion of profits from INSTI(TM) sales, the Foundation plans to donate INSTI(TM) HIV test kits to developing countries.

bioLytical(TM) Laboratories (Inc.) is a leading developer and manufacturer of diagnostic tests for global health care markets. The company produces the highly accurate and reliable INSTI(TM) kit; the only rapid HIV test kit approved by Health Canada for use in a point of care setting, such as a doctor's office or hospital. bioLytical(TM) is a privately owned company with headquarters and manufacturing facility located in Richmond, British Columbia. For more information about bioLytical and INSTI(TM), please visit www.biolytical.com.

Media Contact: Debbie Collins Terry Foster bioLytical(TM) Laboratories James Hoggan and Associates Inc. Telephone: (604) 204-6784 ext. 236 Telephone: (604) 739-7500 Cell: (604) 716-7934 Cell: (604) 765-2488 Toll Free: 1-866-674-6784 Email: tfoster@hoggan.com Email: dcollins@biolytical.com

bioLytical Laboratories

CONTACT: Media Contact: Debbie Collins, bioLytical(TM) Laboratories,Telephone: (604) 204-6784 ext. 236, Cell: (604) 716-7934, Toll Free:1-866-674-6784, Email: dcollins@biolytical.com; Terry Foster, James Hogganand Associates Inc., Telephone: (604) 739-7500, Cell: (604) 765-2488,Email: tfoster@hoggan.com



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