FDA Grants CLIA Waiver to bioLytical Laboratories INSTI Rapid HIV Test

FDA Grants CLIA Waiver to bioLytical Laboratories INSTI Rapid HIV Test – Innovative Screening Assay Detects HIV Antibodies in 60 seconds or less

Richmond, B.C. – July 23, 2012. The INSTI(TM) Rapid HIV-1 Antibody Test, the world’s only proven 60-second test for HIV/AIDS, is being made more widely available to the U.S. population. Found to meet the CLIA Waived performance requirements for finger-stick blood samples, INSTI(TM) can now be used by HIV testers and healthcare providers in a significantly expanded variety of settings.

The INSTI(TM) Rapid HIV Antibody Test is the first rapid HIV test to meet the stringent requirements of the updated Clinical Laboratory Improvement Amendments (CLIA) guidelines, which pertain to the complexity of laboratory tests. A CLIA Waived test is categorized as a “simple laboratory examination or procedure that has an insignificant risk of an erroneous result,” meaning the tests can be performed by untrained users at point-of-care (POC) locations across the country.

“The increased availability of the INSTI(TM) 60-second rapid test in the U.S. is a significant advancement,” says Whitney Engeran-Cordova, Senior Director of Public Health AIDS Healthcare Foundation. “In fact, it is a game-changer and will allow for large-scale testing events and new ways for point-of-care testing in Emergency Rooms. Most importantly, it will lead to new techniques of reaching people.”

Robert Mackie, Chairman of bioLytical commented: “We are extremely excited at having achieved this key milestone in the regulatory approval estate of our flagship INSTI(TM) product. We believe INSTI(TM) to be the most accurate point-of-care HIV antibody detection tests and it is certainly the fastest. It’s also one of the best at early antibody detection. Being CLIA waived will allow INSTI(TM) to be more widely available, including in some novel settings. It will make a significant contribution to both ‘seek and treat’ and ‘treatment as prevention’ initiatives focused on bringing the HIV epidemic to a halt and improving the quality of life of those with the virus.”

While the CLIA regulations apply directly to intended-use sites in the U.S., the impact of the designation is expected to be felt globally. bioLytical Chief Technical Officer Rick Galli commented on the implications of INSTI(TM)’s unique data set for areas of the developing world with a high prevalence of HIV/AIDS: “It is important to be able to demonstrate, as we did in this clinical study, that untrained, non-laboratory users are able to use INSTI(TM) correctly and with a high degree of accuracy in obtaining the right results.” In many parts of Africa, for example, the self-contained test would be invaluable. “From a global perspective, all users can simply read the package insert and do the test without any specialized training.”

Unlike current lateral flow tests which can take between 20 and 40 minutes to yield a result, INSTI(TM) uses bioLytical’s unique flow-through technology, rendering results in less than one minute with 100% sensitivity and 99.8% specificity during the CLIA Clinical Trial. Now that the INSTI(TM) test is CLIA Waived, healthcare providers will be able to deliver reactive or non-reactive results to individuals with unparalleled speed and accuracy in all patient settings, including public health clinics, correctional facilities, and drug stores.

The announcement coincides with the 2012 International AIDS Society (IAS) Conference in Washington, D.C. beginning this week, in which 25,000 members of the AIDS community are expected to share the latest research on the virus. Last year’s IAS conference in Rome brought to the fore the groundbreaking study HIV Prevention Trials Network (HPTN)052, a randomized, phase 3 clinical trial, which shows that early antiretroviral treatment not only benefits the person with HIV, but also dramatically reduces the likelihood that he or she will transmit the virus to sexual partners With more than 60% of infected individuals worldwide unaware of their positive status, according to the 2011 UNAIDS report, rapid testing is the critical first step in this “treatment as prevention” method for curbing the spread of the virus.

“INSTI(TM) has the potential to make ‘treatment as prevention’ strategies more accessible and cost-effective in both developed and developing nation settings,” commented Dr. Christopher R. Shackleton, Executive Director of bioLytical. “The fact that HIV antibody status is conveyed immediately negates the need for a second encounter and the potential for loss to follow-up, as is the case with traditional resource intensive lab-based methodology. It also allows people who test positive to access treatment sooner.”

About bioLytical Laboratories

bioLytical Laboratories is a leading developer and manufacturer of rapid, point of care diagnostic assays. bioLytical is a privately owned, federally incorporated Canadian company based in Vancouver, British Colombia with offices in Chicago and the exclusive manufacturer of the INSTI(TM) HIV Rapid Test kit.

For more information: call 1-866-674-6784 or visit www.biolytical.com

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