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MedMira Files Pre-IDE with FDA for New Rapid HIV Test to Meet Demand for Increased Routine Screening in the US

MedMira Inc., (MedMira), a developer of rapid diagnostic technology and solutions, commends the U.S. Preventive Services Task Force (USPSTF) on its new guidelines calling for routine HIV screening of all people aged 15-65 and all pregnant women in the United States during the normal course of medical care.

The new guidelines will significantly increase the number of people being screened for HIV, as previous recommendations and insurance policies only covered routine testing for individuals considered at high risk. According to the US Centers for Disease Control and Prevention (CDC), approximately 1 in 5 of the 1.2 million people in the US living with HIV do not know that they are infected. The new recommendations, which are available until December 17, 2012 for public comment, are in line with the CDC's recommendations for routine HIV testing for people 13 years of age or older.

"We believe that the USPSTF's new recommendations on routine HIV testing will have a significant influence on the early treatment of those individuals unaware of their HIV infection, as well as preventing the further spread of the disease," said Hermes Chan, CEO, MedMira Inc. "As HIV testing becomes part of routine visits to doctor's offices and convenience care clinics, we expect to see an increased demand for high quality, efficient, rapid tests designed for use at the point-of-care. With this in mind, we are bringing a whole blood version of our Reveal G3 rapid HIV test to US healthcare providers. Our technology enables a 3 minute procedure and instant results for HIV screening, and a highly cost-effective diagnostic tool for healthcare providers and their patients."

Earlier this month, MedMira submitted a pre-IDE (Investigational Device Exemption) information package to the U.S. Food and Drug Administration (FDA) for a whole blood rapid HIV test. The Company currently sells its Reveal G3 Rapid HIV-1 Antibody Test in the US for use in laboratories and hospitals. The new version will be aimed at physician offices, convenience care clinics, mobile testing, and large scale public health programs where whole blood specimens are preferred and much of the new routine HIV screening will take place.

The USPSTF is an independent group of national experts in prevention and evidence-based medicine that works to improve the health of all Americans by making evidence-based recommendations about clinical preventative services, such as screenings, counseling services, and preventative medications. USPSTF recommendations have formed the basis of the clinical standards for many professional societies, health organizations, and medical quality review groups.

MedMira is a leading developer and manufacturer of flow-through rapid diagnostics and technologies. MedMira is the only Canadian company to be awarded US Army contracts for the development of rapid tests for HIV and Hepatitis viruses. The Company's testing solutions provide hospitals, labs, clinics and individuals with reliable, rapid diagnosis for diseases such as HIV and hepatitis C in just three minutes. The Company's tests are sold under the Reveal®, Multiplo™ and Miriad brands in global markets.

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