MedMira Inc., a leading developer and manufacturer of Rapid Vertical Flow Technology diagnostics, has made significant progress in obtaining regulatory approvals for its infectious disease rapid tests. The company has submitted two product applications to Health Canada and one submission to the US Food and Drug Administration (FDA). This progress comes in response to the increased demand for quick and affordable testing methods due to the COVID-19 pandemic.
In Canada, MedMira aims to combat the rising prevalence of infectious diseases and meet the growing demand for testing solutions. The company has received valuable feedback from Health Canada regarding its submissions made in June 2023. MedMira’s regulatory and compliance team promptly responded with comprehensive answers within the required timeframe.
In the US, MedMira is focused on achieving a Clinical Laboratory Improvement Amendments (CLIA) waiver for its HIV rapid test, which has already received FDA pre-market approval. The CLIA waiver designation would allow the company to expand its sales to screening programs supported by various state-funded agencies and non-CLIA waived laboratories. This would significantly increase the potential market from the current USD$2 million to a substantial USD$350 million per annum.
To obtain the CLIA waiver, MedMira has submitted the first label claim through the 510(k) process for its HIV-2 component. The company has completed a clinical trial study in the Ivory Coast demonstrating a sensitivity of 100% for HIV-1 and an outstanding 98.18% for HIV-2. The Reveal® G4 rapid HIV antibody test achieved a flawless 100% specificity and was reactive in early HIV-1 infections and seroconverts.
Hermes Chan, CEO of MedMira Inc., expressed enthusiasm for continued collaboration with Health Canada and the FDA. He highlighted that the high sensitivity and specificity of MedMira’s tests have been confirmed independently over the years. While the timeline for regulatory review cannot be guaranteed, the company is dedicated to responding to inquiries as quickly as possible to achieve the necessary approvals.
MedMira’s tests, based on patented Rapid Vertical Flow Technology, provide instant disease diagnosis, including HIV, syphilis, hepatitis, and SARS-CoV-2, in just three easy steps. These tests are sold globally under the Reveal, REVEALCOVID-19, Multiplo, and Miriad brands. MedMira’s corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada.
In conclusion, MedMira Inc. has made significant progress in obtaining regulatory approvals for its infectious disease rapid tests in both Canada and the US. The company’s goal is to combat the increasing prevalence of infectious diseases and meet the rising demand for testing solutions. By receiving valuable feedback and successfully completing clinical trials, MedMira is getting closer to achieving its objectives and providing cost-effective and rapid testing options to alleviate the strain on healthcare systems.
