U.S. FDA Approves MedMira’s Advanced Reveal G4 Rapid HIV-1/2 Antibody Test
HALIFAX, NOVA SCOTIA / ACCESSWIRE / December 13, 2023 / MedMira Inc. (MedMira) (TSXV:MIR) proudly announces today the successful attainment of 510(k) clearance for the HIV-2 claim on the Reveal® G4 Rapid HIV-1/2 antibody test in the United States. This achievement marks a significant milestone for MedMira, positioning the company as a key player in the HIV testing landscape and addressing the demand for comprehensive HIV screening mandated by various State laws across the nation.
“We are thrilled to announce the 510(k) clearance for the HIV-2 claim on the Reveal® G4 Rapid HIV-1/2 antibody test in the United States,” said Hermes Chan, CEO at MedMira. “This milestone underscores our commitment to providing high-quality diagnostic solutions that align with the dynamic landscape of HIV screening. The inclusion of the HIV-2 claim not only meets regulatory requirements but also positions us as a frontrunner in addressing the unique needs of healthcare providers and communities nationwide.”
With the expanded claim and the ongoing pursuit of CLIA waiver status, MedMira anticipates a significant increase in demand for the Reveal® G4 Rapid HIV-1/2 antibody test in the coming year. The company is optimistic about the positive impact it can make in the fight against HIV by offering a high-quality, faster, and more accessible antibody testing option to healthcare professionals and individuals across the United States.
The addition of the HIV-2 claim to the Reveal® G4 Rapid HIV-1/2 antibody test is particularly crucial, considering the diverse prevalence of HIV subtypes in the United States. This clearance not only meets the regulatory requirements but also aligns with the evolving needs of healthcare providers and public health initiatives, ensuring that individuals receive accurate and reliable results for both HIV-1 and HIV-2.
The Reveal® G4 Rapid HIV test has consistently demonstrated exceptional performance, and with the expanded claim, it is well-positioned to meet the demand for a rapid and reliable testing solution. The inclusion of the HIV-2 claim further strengthens the test’s utility and compliance with various State laws, making it an essential tool in the fight against HIV.
In light of this achievement, MedMira is actively pursuing the Clinical Laboratory Improvement Amendments (CLIA) waiver for the Reveal® G4 Rapid HIV-1/2 test. The CLIA waiver, once obtained, will streamline the accessibility of the test and empower a broader range of healthcare professionals to administer it. This strategic move is expected to enhance the reach and impact of the Reveal® G4 HIV-1/2 test, making it more readily available to communities across the United States.
About MedMira
MedMira is a leading developer and manufacturer of Rapid Vertical Flow Technology® diagnostics. The Company’s tests provide hospitals, labs, clinics and individuals with instant disease diagnosis, such as HIV, syphilis, hepatitis and SARS-CoV-2, in just three easy steps. The Company’s tests are sold globally under the Reveal®, REVEALCOVID-19®, Multiplo® and Miriad® brands. Based on its patented Rapid Vertical Flow Technology, MedMira’s rapid HIV test is the only one in the world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira’s corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit www.medmira.com and follow us on Twitterand 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 regulatory approval, product launch, 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.
Media Contacts:
MedMira, Inc.
Markus Meile
Chief Financial Officer
ir@medmira.com
SOURCE: MedMira, Inc.
View the original press release on accesswire.com
