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MedMira Makes Advances On HIV Point-of-Care Testing Market in the U.S.

Apr 23 2015

Today, more than 1.2 million people in the United States are living with HIV, but as many as 168,000 (or 14%) remain unaware of their infection. In the US there are 50,000 new HIV infections reported every year, in part due to those people who unintentionally spread the disease simply because they do not know they are HIV positive.  Helping people know...® has always been the inspiration driving MedMira forward, as it continues to evolve its rapid testing technology and applications.

For over 30 years, diagnostic tests and screening programs have been critical components in combatting the spread of HIV.  These years have seen tests progress from the first lab-based approved blood test which took weeks to produce a result, to rapid tests that can screen whole blood, serum or plasma specimens and deliver a result within minutes. 

Earlier this week MedMira filed a supplement seeking United States Food and Drug Administration (FDA) approval on new whole blood testing features being added to its Reveal rapid HIV test, which has been used successfully in hospitals and laboratories for more than 10 years.  The next generation in the Reveal product line, Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4), will add the detection of HIV antibodies in both fingerstick and venipuncture whole blood to the existing serum and plasma testing currently available in Reveal G3 Rapid HIV-1 Antibody Test. 

As the U.S. Preventative Task Force guidelines, which were passed in 2012, are implemented, HIV testing becomes a part of mainstream, everyday healthcare.  In those guidelines every person aged 15 to 65 and all pregnant women are recommended to have a HIV screening test as part of their routine wellness testing. The testing can take place in physician offices, mobile health vehicles, rapid care clinics, big box retail stores, airports, and other community-based settings where individuals regularly access healthcare services. 

Like all MedMira rapid tests, the Reveal G4 test is built on the Company’s patented Rapid Vertical Flow (RVF) Technology™, which has unique features not found in competing technologies.  RVF Technology enables the Reveal G4 test to deliver instant results following a simple 3-step procedure that takes less than two minutes, start-to-finish.  This speed is unmatched by other FDA-approved rapid tests, which typically take 20 to 25 minutes to produce a result. 

HIV testing is becoming more routine, however the testing experience is anything but routine for the individuals waiting to find out their HIV status. While the primary focus of rapid HIV testing is helping people know their HIV status, healthcare providers need to cost-effectively implement this service in their practices and programs.  The difference between a two minute test vs. a 20 minute test can have a huge impact on the stress level of the patient, the testing process, the number of patients tested per day, the human resources expended on each patient. The combination of these factors means that it is possible for a healthcare provider to improve the patient experience and at the same time, improve their bottom-line.

When Reveal G4 receives approval, it will offer users across every testing setting – from the laboratory to the point-of-care, a simple, cost-effective testing solution.  Reveal G4 will be available in three convenient formats including:

  • POC – an all-in-one convenience kit for testing at the point of patient care using fingerstick specimens;
  • LAB+ - maximizes flexibility for customers using venipuncture whole blood, serum or plasma specimens; and
  • LAB S/P – designed for use in laboratories and batch testing

Reveal G4 will open new market sectors in point-of-care testing for MedMira and this submission is a major milestone in the Company’s ongoing expansion in to the United States, with the opening of a U.S. office and the expansion of its product line with additional product submissions over the coming months.