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  • Writer's pictureMedMira

FY2023 Update

Corporate Update

Throughout the reporting period, the Company achieved significant milestones in its pursuit of FDA and Health Canada approvals for a range of products. A standout accomplishment is the progress made with MedMira’s 510(k) (FDA) approval for its Reveal G4 Rapid HIV-1/2 antibody test. MedMira has submitted a comprehensive study for the additional HIV-2 claim based on the Company’s completed study in the Ivory Coast. The study showed a sensitivity of 100% for HIV-1 and HIV-2. In addition, MedMira’s Reveal® G4 rapid HIV antibody test achieved a flawless 100% specificity and was reactive in early HIV-1 infections and seroconverts. In November 2023, MedMira received the feedback and with it the FDA acknowledged the successful substantive review completion. With this the Company will enter into the interactive review process to finalise any outstanding items such as labels and packaging inserts.

The Company anticipates this new approval within December 2023 and with it is able to significantly increase its sales in the US through its existing distribution network. The inclusion of the HIV-2 component allows CLIA laboratories, clinics or hospitals, to use MedMira’s test. The Reveal G4 Rapid HIV test has consistently demonstrated outstanding performance, and with the pending approval, it is poised to fulfil the increasing demand for a rapid and reliable testing solution. The approval of the HIV-2 claim will further bolster the test's utility, ensuring compliance with various State laws and solidifying its role as a crucial tool in the fight against HIV. This anticipated approval allows MedMira’s existing customers to expand the usage of the Reveal® G4 and provides access to new and larger customers. As a result, the Company anticipates a significant increase in sales over the coming months.

HIV-2 is an essential part in today’s HIV testing, notably , all US States have mandated HIV tests to possess the capability to detect both HIV-1 and HIV-2 antibodies. The inclusion of the HIV-2 claim in the Reveal G4 Rapid HIV 1/2 antibody test is of paramount importance, considering the diverse prevalence of HIV subtypes in the United States. This potential approval aligns not only with regulatory requirements but also with the evolving needs of healthcare providers and public health initiatives, ensuring accurate and reliable results for both HIV-1 and HIV-2.

Additionally, we are expediting the completion of the Reveal® TP (Syphilis) rapid test, which is in high demand in both Canada and the USA due to the escalating syphilis infections in these countries. An update will be provided in the coming month with regard to the Company’s submission.

Subsequent to FY2023, MedMira signed a product development agreement with a US based governmental agency. The product will be based on MedMira’s unique RVF® Medduo platform which allows the detection of up-to 8 biomarkers in one test. Details to the product development are classified and MedMira will provide further details when possible.


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