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MedMira Submits Reveal G4 Whole Blood Rapid HIV Test For U.S. FDA Approval

MedMira Inc. has completed the submission of a supplement to their existing Premarket Approval for the United States Food and Drug Administration (FDA) approval of the next generation of its Reveal rapid HIV test. The supplement requests FDA approval of Reveal® G4 Rapid HIV-1 Antibody Test (Reveal G4), which adds the detection of HIV antibodies in fingerstick and venipuncture whole blood, to the product's current capabilities in testing serum and plasma specimens.

"Reveal G4 represents a significant milestone in our sales and marketing expansion in the United States and this submission marks the first in a series of regulatory submissions we will be making as we introduce new products in this market," said Dr. Kevin Jones, Senior Director, Global Sales & Marketing, MedMira Inc. "Reveal G4 also builds on MedMira's commitment to delivering the most innovative rapid testing solutions to our customers. The whole blood capabilities in Reveal G4 will expand product applications to physician offices, mobile testing vehicles, and convenience care clinics where much of the HIV testing is taking place as healthcare providers implement the latest guidelines for routine screening."

Built on MedMira's patented Rapid Vertical Flow Technology™ (RVF) platform, Reveal G4 offers point-of-care (POC) users a simple 3-step whole blood procedure which is completed in less than three minutes. The product will be sold in three distinct packaging formats, designed to meet the needs of a broad range of customers, including fingerstick whole blood (POC format), venipuncture whole blood/serum/plasma (LAB+ format), and serum/plasma (LAB S/P).

MedMira has successfully served customers in hospitals and laboratories with a serum/plasma version of its Reveal rapid HIV test for the past decade. Reveal is routinely ranked as a top performer in these market sectors with the highest sensitivity and specificity as well as performance comparable to complex laboratory systems.

The submission to the FDA is based on results from multi-center clinical trials conducted across the United States where Reveal G4 showed excellent results with fingerstick and whole blood specimens from a broad range of demographics. The additional whole blood capabilities of Reveal G4 will enable healthcare providers to better serve individuals 15-65 years of age and pregnant women seeking routine screening, helping to reduce the 50,000 new HIV infections in the US each year, including 100 to 200 babies born with HIV.

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