MedMira Inc. announced 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.

With the expanded claim and the ongoing pursuit of CLIA waiver status, MedMira anticipates a significant increase in demand for the Reveal®? G four Rapid HIV-1/2 antibodies 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®? G 4 Rapid HIV-1/2 antigen 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-1/2 antibody testing 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®? G3 HIV-1/2 test, making it more readily available to communities across the United States.