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MedMira Gets FDA 510(k) Clearance for HIV-2 Claims for HIV-1/2 Test

NEW YORK – Canadian diagnostics firm MedMira on Wednesday said it has secured US Food and Drug Administration 510(k) clearance for the HIV-2 claim that will be used in its rapid antigen tests for HIV-1/2 detection.

The Nova Scotia-based company said marketing clearance of the claim for its Reveal G4 Rapid HIV-1/2 antigen test that will help the firm address demand for comprehensive HIV screening across the US. It added it is also seeking CLIA-waived status for the HIV assay to expand access to the product.

"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," MedMira CEO Hermes Chan said in a statement.

The firm said the HIV-2 claim is crucial because of the diversity of HIV subtypes circulating in the US. The 510(k) clearance aligns the claims for the firm's tests with the needs of healthcare providers and public health agencies, it said.

MedMira noted that the test integrates its rapid vertical flow technology, which uses gravity to move fluid down through the assay compared to the capillary reaction used to move fluid through lateral flow tests. Company officials have said that the vertical flow process hastens the test reaction time.

The recent clearance expands on the claims for MedMira's existing Reveal G4 test for HIV, which it has been selling in the US with FDA premarket approval. The firm also gained CE marking in 2017 for its Multiplo TP/HIV test that is used to screen for HIV and syphilis-causing Treponema pallidium infections.