MedMira Receives FDA Approval for the Reveal G4 Rapid HIV-1 Antibody Test
Oct 19 2015
Expands Proven Rapid Vertical Flow Technology™ Platform to Next Generation Whole Blood Rapid HIV Test and New Market Sectors in the U.S.
Halifax, Nova Scotia, October 19, 2015 – MedMira Inc. (MedMira) (TSXV: MIR) 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.
Reveal G4 is available through the U.S. distribution network including VWR International, LLC and Cardinal Health.
Cat. No. 815311007583 Point-of-Care Format for fingerstick whole blood testing
Cat. No. 815311007576 LAB+ Format for venipuncture whole blood, serum or plasma testing
Cat. No. 815311000591 LAB S/P Format for serum or plasma testing
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.
MedMira is the developer and owner of Rapid Vertical Flow (RVF) Technology. The Company’s rapid test applications built on RVF Technology provide hospitals, labs, clinics and individuals with instant diagnosis for diseases such as HIV and hepatitis C in just three easy steps. The Company’s tests are sold under the Reveal, Multiplo™ and Miriad™ brands in global markets. MedMira’s corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada and the Company has a sales and customer service office located in Atlanta, Georgia, United States. For more information visit medmira.com. Follow us on Twitter and LinkedIn.
This news release contains forward-looking statements, which involve risk and uncertainties and reflect the Company’s current expectation regarding future events including statements regarding possible approval and launch of new products, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Hermes Chan, Director/CEO
Andrea Young, Corporate Communications