bioLytical Laboratories

bioLytical Laboratories

July 10, 2007 12:26 ET

bioLytical Receives FDA Clearance to Initiate Clinical Trial for 60-Second HIV Test

VANCOUVER, BRITISH COLUMBIA--(Marketwire - July 10, 2007) - bioLytical Laboratories (bioLytical) announced today the U.S. Food and Drug Administration (FDA) has accepted the Investigational Device Exemption (IDE) application for INSTI™, a 60-second rapid HIV test for point-of-care testing. The acceptance clears the way for bioLytical to immediately begin its US clinical trials.

"The acceptance of our IDE application for INSTI™ is an important first step in providing US residents unparalleled access to a very quick and highly accurate HIV test," says Richard Galli, Chief Technical Officer of bioLytical. "Both patients and healthcare providers will benefit from the simple format which boasts superior accessibility and ease of use compared to traditional testing methods."

bioLytical is a Canadian company that develops and manufactures the INSTI™ Kit: a unique, simple-to-use test kit for the diagnosis of HIV infection. At 60 seconds for a reading, it is by far the fastest HIV diagnostic kit in the world. INSTI™ is the only HIV test kit approved by Health Canada for point-of-care testing and is the fastest of those with CE Mark approval.

The 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. Currently available rapid HIV antibody tests seek to improve access to HIV testing however most must be administered in clinical setting and have longer response times which can be a deterrent for many. bioLytical's INSTI™ kit provides accurate results in 60-seconds and is ideal for point-of-care testing, thus allowing the testing to be done on a mobile, in-field basis allowing potentially all communities to be reached and social barriers to be removed.

"The success of our IDE application brings bioLytical one step closer to offering the world's fastest HIV test to US markets," says bioLytical COO Matthew Clayton. "bioLytical believes testing is the crucial first step in the fight against HIV and we are eager to work with the FDA in order to offer INSTI™ to US healthcare providers as a necessary tool in preventing the spread of the virus."


INSTI™ is a highly effective and reliable rapid HIV test that detects the presence of antibodies to HIV in whole blood, serum or plasma in 60 seconds. It has a 99.96% accuracy rate, as demonstrated in extensive clinical trials carried out in multiple centers across Canada. To further ensure INSTI™ maintains its high quality, it is manufactured in Canada under strict controls in a state-of-the-art ISO accredited facility. INSTI™ is the only HIV kit approved by Health Canada for point-of-care testing and also has CE mark approval.


bioLytical 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™ kit; the only rapid HIV test kit approved by Health Canada for use in a point-of- care setting. bioLytical is a privately owned company with headquarters and 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

This news release is not, and under no circumstancces 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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