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MedMira Receives FDA Approval for the Reveal® G4 Rapid HIV-1 Antibody Test

MedMira Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the next generation of the Company's rapid HIV test, Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4). Reveal G4 adds new capabilities in testing fingerstick and venipuncture whole blood specimens which extends the Reveal product line into point-of-care settings and new market segments within the U.S. healthcare market.

With the approval of Reveal G4, MedMira is poised to capitalize on the rising demand for point-of-care whole blood HIV testing in the U.S., where today more than 1.2 million people are living with HIV, and as many as 168,000 remain unaware of their infection. Built on the motto of helping people know…®, MedMira has been employing its patented Rapid Vertical Flow Technology to deliver fast, accurate, high quality rapid HIV tests to healthcare providers and their patients in the U.S. since 2003, when the first generation of the Reveal rapid HIV test received FDA approval. With an initial focus on laboratories and hospitals where most of the HIV testing uses serum and plasma specimens, MedMira now moves to the front lines of healthcare with Reveal G4. Rapid tests are routinely being conducted in community based, point-of-care settings, where accessibility and convenience encourage more people to get tested during regular medical check-ups.

"With this FDA approval of Reveal G4, we are bringing the latest advancements in our Rapid Vertical Flow Technology platform to our U.S. customers. Reveal G4 delivers the same speed, performance, and quality that customers have come to know as hallmarks of our technology platform, and now we've added whole blood applications. This product is all about creating a rapid HIV testing solution that gives healthcare providers and their patients choices that make testing possible in any setting," said Hermes Chan, CEO, MedMira Inc. "Reveal G4 will make a significant contribution to increasing cost-effective, patient-focused HIV testing at the point-of-care, while continuing to serve the needs of our customers in laboratories and hospitals."

Reveal G4, like all MedMira tests, is built on the Company's patented Rapid Vertical Flow Technology platform which offers unique advantages unmatched by competitors. Users can obtain instant results from a Reveal G4 test following a simple 3-step testing procedure; add the specimen, process with the InstantGold™ cap, and read the results. This enables counselling, and if needed, initial treatment, to be delivered in a single patient visit. The streamlined testing approach and instant results that Reveal G4 facilitates translates to higher patient throughput for clinics and a reduction in the number of patients who are lost to follow-up, never returning for their results. As healthcare providers look for cost-efficient ways to integrate routine HIV testing in their practices and programs, a tool like Reveal G4 offers the speed and quality which will be critical to success.

In addition to its Reveal G4 test, MedMira is developing a broad range of rapid tests for major infectious diseases, as it continues to capitalize on the capabilities of its proprietary Rapid Vertical Flow Technology platform to create multiplex rapid tests that diagnose multiple infections on a single test with a single drop of specimen.

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