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“Vatic COVID-19 Home Spike Test” OTC EUA Submitted to FDA
“Vatic COVID-19 Home Spike Test” OTC EUA Submitted to FDA
16 March 2022
“Vatic COVID-19 Home Spike Test” OTC EUA Submitted to FDA
Could Be Only Authorized SALIVA Rapid Test; Preferred to Nasal swabs by 4x in user testing
OTC Self-Test Detects Virus Via ACE-2 Protein Binding to Trimeric Spike with Mouth Swab
MARCH 16, 2022 – Vatic Health Limited (https://www.vatic.health/usa) today announces that it has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for a non-prescription Over The Counter (OTC) 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.
The clinical testing data submitted as part of the company’s filing documented that this novel 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.
“Vatic is excited to submit this compelling data to the FDA for its consideration. If authorized 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,” stated Dr. Mona K. Omir, Co-Founder and CTO of Vatic Health.
How does it work?
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.
“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,” said Alex Sheppard CEO, and Co-Founder of Vatic Health.
For media enquiries please contact: vatic@transatlanticent.com
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