Vitagene, the precision health company, announced the immediate availability of 50,000 U.S. Food and Drug Administration (FDA)-authorized “zero contact” at-home COVID-19 test kits for use during the current public emergency. Vitagene is using the 1Health.io platform to facilitate compliance with FDA requirements for assessment of symptoms, telehealth and electronic tracking of the test kit.
Currently, consumers who are showing symptoms of COVID-19 infection are expected to drive or take mass transit to a clinic or stay for hours in a drive-through testing line. With the Zero Contact COVID-19 test, patients will get a kit at home eliminating the need to drive or be at risk going to a clinical setting.
“Our mission as a team is to help our customers improve their health and wellness,” said Mehdi Maghsoodnia, CEO at Vitagene. “Our customer’s number one need right now is access to COVID-19 testing. That is why our team, alongside our partners, have been working day and night to bring this test to market with physician approval, telehealth supervision and a clear chain of custody tracking.”
The current COVID-19 tests require that the healthcare provider be in the same room as the patient with symptoms, creating risk of infection for the healthcare provider. Once the traditional specimen collection is conducted, the provider then needs to disinfect their garments to minimize the risk of cross contamination. With Zero Contact, both patients and healthcare workers need not be in the same place while the test is being administered.
Saliva test kits are readily available today; in fact, Vitagene is committed to providing 50,000 tests in the first month of service and scaling that number to 300,000 tests per month beginning in middle of this month. Additionally, Vitagene has partnered with supply chain manufacturers to provide the kits, which are manufactured in the United States, supporting the economy and providing local employment.
“Our new, efficient, and self-contained saliva collection kits using the EUA approved SDNA-1000 device, makes not only sample collection easy but sample transport as well,“ said Stephen Fanning. CEO of Spectrum Solutions. “ The proprietary preservation solution inactivates the virus once a biosample is collected to the point that we are able to suspend and stabilize the viral RNA transcripts for sensitive and specific qPCR testing by the lab. Another incredible benefit of our process is that we can help limit undue exposure making the testing for COVID-19 safer for everyone involved.”
Today, many communities do not have convenient access to hospitals or other testing facilities. Combined with limited nasal test availability, this has led to only 1 percent of people being tested in the United States to date. In order to decrease and manage the health and economic risks of COVID-19, society needs access to widespread testing. Now, anyone who thinks that he or she might have been exposed can go to Vitagene.com and start the process of being tested.
“Our saliva-based test kit makes it possible for patients across the United States to have access to testing, not just those located near a hospital, clinic or testing facility.” said Andrew Brooks, chief operating officer and director of technology development at the university’s RUCDR Infinite Biologics lab. “Millions of Americans, who until now might have to travel hours to their nearest testing location, can be sent a test by their doctor or clinic.”