One of the many ideas that cropped up to meet diagnostic demands is at-home COVID-19 tests. Currently, five companies are selling at-home tests authorized by the FDA. But can the results be trusted? And what other tests may be on the way?
Episode 22: Interviews Lotti Bluemner CEO | Joe Cotela Lead Singer of DED | Mehdi Maghsoodnia CEO of Vitagene
Mehdi Maghsoodnia is the Chairman and CEO of Vitagene. He joined the company in February 2016. Maghsoodnia brings over 20 years of experience in executive management roles at both public and private companies and has deep expertise in building technology companies in new markets. Prior to Vitagene, Maghsoodnia held a number of executive positions including CEO of Rafter, SVP of CafePress, Intellisync (Acquired by Nokia), and Actiance. Maghsoodnia is also an active angel investor and board member in several early-stage startups including SpineZone, MedCorder, Turncare, Swiftly, and StrongDM. Maghsoodnia received his Bachelor of Science degree in Electrical Engineering and Computer Science from the University of California, Berkeley, and has done graduate-level studies in computer science at Stanford University.
A handful of U.S. health care companies are banking on massive demand for coronavirus tests and an easing of federal rules as they prepare for a major production blitz that could bring at-home saliva test kits to millions of Americans in the coming months.
Andrew Brooks, a Rutgers University molecular neuroscientist, remembers clearly having a long nasopharyngeal swab stuck up his nose in search of evidence of a virus. “It was terrible,” he recalls. “It felt like someone was poking the front of my brain.”
Vitagene has launched ‘Zero Contact’ Covid-19 home test kits authorised by the Food and Drug Administration (FDA). The company is using the 1Health.io platform to facilitate compliance with FDA requirements for assessment of symptoms, telehealth and electronic tracking of the test kit.
With the much-heralded Rutgers University saliva test for the coronavirus garnering the Food and Drug Administration’s blessing late Thursday, people can now collect their own test samples at home and send them out to be processed.
Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens
Today, the U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT), which had been previously added to the high complexity molecular-based LDT “umbrella” EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. This announcement builds on last month’s EUA for the first diagnostic test with a home-collection option, which uses a sample collected from the patient’s nose with a nasal swab and saline.