Molecule Holdings (MH) has secured North American distribution for one of the first COVID-19 IgM/IgG Antibody Rapid Tests to receive FDA/EUA approval.
Conducted with a finger prick, results from these tests become visible within 15 minutes. MH has the right partners with 10+ years in rapid testing. MH's partners have been verified and pass all necessary global quality assurance and safety certifications.
Molecule is distributing a reliable test whose claims have been independently evaluated by the FDA and found to be accurate. In addition, the test was evaluated in a large population-based sero-epidemiological study, which in its final analysis, provided further validation of the test's reliability.
Antibody tests tell clinicians if the subject has been recently exposed to the virus and is still contagious (IgM), has been exposed is still contagious and but is developing an immune response (IgM and IgG), was exposed, is no longer contagious and has now developed an immune response (IgG) or has not been exposed at all (no antibodies present). This makes antibody tests a powerful tool for diagnostic screening and getting people safely back to work.
In addition to FDA/EUA approval, these tests have received the CE mark in accordance with EU health and safety standards.