Molecule Holdings issued the following announcement on June 8.
In the initial scramble to quell the impact of the COVID-19 pandemic, the rapid antibody test market was been flooded. Not all tests are created equal and the COVID-19 crisis introduced the opportunity to try unproven players in rapid diagnostic testing.
After enduring a long wait and independent evaluation process, Molecule Holdings is thrilled to announce it 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 simple finger prick, results from these tests become visible within 15 minutes. MH has the right partners with 10+ years in rapid testing. Because of this, they can assure clients they have the ability to help them find a testing solution for COVID-19. 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.
The importance of having access to these types of tests cannot be overstated. 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.
Maintaining some of the highest customer service standards in the industry, Molecule offers a web portal to educate customers and clinicians on sample collection, test administration and results reading. The training portal is tailored to fit CLIA compliance processes and can be translated into other languages.
In addition to FDA/EUA approval, these tests have received the CE mark in accordance with EU health and safety standards.
Original source can be found here.
