Vatic Health has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for a non-prescription over-the-counter Vatic COVID-19 Home Spike Test, a rapid saliva test that detects the open, active trimeric spike protein on the surface of the SARS-CoV-2 virus.
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The clinical testing data submitted as part of the company’s filing documented that this approach to rapid self-testing has shown very high sensitivity (93% (40/43, 93% CI: 80.9-98.5%)), and 100% specificity (31/31, 95% CI: 88.8-100%), using saliva (mouth) swabs rather than nasal swabs, with the testing having taken place at the height of the Omicron wave in the U.S. The test showed a high level of user preference with four times as many participants reporting that they would use the saliva test again compared to the nasal alternative.
Dr. Mona K. Omir, co-founder and CTO of Vatic Health, said: “Vatic is excited to submit this compelling data to the FDA for its consideration. If authorised for Emergency Use, the Vatic COVID-19 Home Spike Test will allow consumers a simpler, more comfortable COVID-19 self-test that showed no false positives in our initial U.S. clinical testing. The Vatic COVID-19 Home Spike Test leverages the host cell entry mechanism of the virus to identify its presence in a saliva sample. It only gives a positive result if it detects the active surface conformation of coronavirus trimeric spike protein. We know of no other COVID-19 tests that uses this unique science.”
An active coronavirus is covered in spike protein 'keys' that the virus uses to bind to human cells, enter, make copies of themselves, and thereby cause an infection. Without these spike protein keys the virus is unable to infect a human cell and cause illness. The Vatic test uses a saliva sample to determine if a spike protein 'key' is present and generates results in just fifteen minutes.
Alex Sheppard CEO, and Co-Founder of Vatic Health, added: “This EUA submission is a key milestone in Vatic's growth. Our unique technology allows us to detect novel biomarkers and generate health information that has been traditionally limited to the lab. We see this as the next step on our journey to helping more people get key insights into their health at home.”
