FDA Grants Emergency Use Authorization for COVID-19 Rapid Antibody Fingerstick Test

Nirmidas Biotech Inc., a member of the StartX Med COVID-19 Task Force, announces its second U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), for its COVID-19 rapid antibody IgG/IgM test, now available for point-of-care (POC) settings. The MidaSpot COVID-19 Antibody Combo Detection Kit uses a fingerstick serology test for detecting antibodies against the RBD antigen on the surface of the SARS-CoV-2 virus.
 
Nirmidas is the first U.S. company to receive an FDA EUA for a COVID-19 point-of-care fingerstick antibody test. The MidaSpot COVID-19 Antibody Combo Detection Kit can now be administered widely in CLIA-waived settings for point-of-care testing (e.g., doctor’s offices, urgent cares, ERs, pharmacies, nursing home facilities, and testing sites, etc.). The high-performance test is easy to use, no instrument is needed, and yields results in 15 to 20 minutes. The test will facilitate rapid decisions in POC settings to identify individuals with recent or prior infection and perform population surveillance for communities and organizations to help guide resource deployments.
 
In point-of-care testing, the Nirmidas rapid test detects and differentiates antibody IgG and IgM post COVID-19 infection. In clinical studies of COVID-19 patients with fingerstick whole blood, the MidaSpot Antibody POC test showed 100 percent sensitivity for IgG after 14 days post symptom onset and 100 percent sensitivity for IgM after seven days post symptom onset.
 
Nirmidas’ earlier COVID-19 rapid antibody test has been deployed in more than 10 states in the United States and multiple U.S. military bases. While the earlier version received an FDA EUA for high and moderate complexity laboratories only, the MidaSpot POC authorization will significantly expand its user base. Nirmidas is well-positioned for ramping up and meeting the multi-million test level manufacturing demands at a low cost, in addition to establishing partnerships with distributors for test availability in the United States and globally.
 
“As the world is deeply impacted by the outbreak and rapid spread of the SARS-CoV-2 virus, widely available rapid detection of antibodies is becoming indispensable as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, assessing population prevalence, and potential immunity,” states Dr. Meijie Tang, co-founder and CEO of Nirmidas Biotech.
 
The Nirmidas team has a significant track record of antibody testing going back to the Zika and Dengue viruses. It has been developing COVID-19 tests since February 2020 with three COVID-19 tests now launched. Its third test for home-collection saliva antibody detection, currently for research use, is based on a nanotechnology platform pGOLD high accuracy assay. The work was a result of a collaboration between Nirmidas, Lifebridge Health, Sutter Health and the California Department of Public Health and was published recently in Nature Biomedical Engineering. In addition, the Nirmidas team is developing pGOLD assays for the neutralization antibodies to study immune response to vaccination.
 
Commenting on the pGOLD test, Professor Hongjie Dai of Stanford University, who worked on the study as a consultant and scientific advisor, stated, “The nanotechnology based platform has antibody avidity test capability to assess infection timing, and saliva testing capability for non-invasiveness without compromising performance. I am glad that our basic research in this nanotechnology area can contribute to combatting the pandemic.”
 
Another differentiator is rooted in the superior analytical sensitivity of the pGOLD nanotechnology platform enabling detection of minute amounts of antibodies in human saliva. This offers one of the first tests for non-invasive detection of SARS-CoV-2 antibodies, useful for population-based mass screening through home sample collection. The antibody content in saliva is typically in orders of magnitude lower and requires a highly-sensitive technology to be detected.
 
Tang is among more than 150 Stanford alumni and professor scientists, physicians, and engineers participating in the StartX Med COVID-19 Task Force, mobilized at the onset of the pandemic to provide critical solutions for the prevention, diagnostics, and treatment of the novel coronavirus. The highly-collaborative group has been meeting twice-weekly for the past 10 months on solutions for health systems, local governments, and communities most in need.