LEHI — A Utah-based diagnostic testing company says its continuing its pursuit of authorization from the U.S. Food and Drug Administration to issue emergency approval for a COVID-19 test that’s already in use in Europe and could markedly amp up testing capacity in Utah and other areas of the Intermountain West.
The company says it has the resources to produce 50,000 or more of the tests daily from its Salt Lake facility. Each test, according to the company, costs about $10 per patient, delivers results in about 90 minutes and can be processed at most medical labs.
During a community leaders call hosted Monday by Utah tech sector advocacy group Silicon Slopes, Co-Diagnostics communication director Seth Egan said his company has already earned approval from the European Union for its test, which uses a sputum sample to look for evidence of COVID-19, but continues to await action from the FDA under the agency’s expedited emergency use protocol for COVID-19 testing.
“With FDA approval through emergency use authorization we could supply all of the testing needs in Utah and around us easily,” Egan said. “We sit here a little bit amazed that we have a test available in European nations but we can’t sell it as a clinical diagnostic in our own home state.
“We do have the ability to make 50,000-plus tests a day and get them out to our community.”
The FDA did not immediately respond to a Deseret News request for a status report on the agency’s assessment of the Co-Diagnostics test.
A lack of testing capacity is being repeatedly cited by public health experts as one of the biggest hindrances to getting a clear view, from the local to global level, on exactly how far and wide COVID-19 has spread.
Silicon Slopes Executive Director Clint Betts said the call was part of his group’s ongoing efforts to bring the expertise and resources of Utah’s expansive tech community together with elected officials and community leaders to help stem the tide of the pandemic, while ensuring that the state’s most vulnerable residents are getting the help they need.
Other efforts brought up on the call include a website currently under development by the University of Utah that would act as a digital screening mechanism to assess an individual’s relative need for COVID-19 testing, based on an online questionnaire, and automatically connect the user with appropriate resources, like testing opportunities, based on their needs.
Silicon Slopes tech experts are pitching in to help ensure tools like this online portal have the development support they need to get completed as quickly as possible.
Nomi Health founder and CEO Mark Newman said he and his colleagues have already jumped into the work, raising over $1 million to help everyone who needs to get tested to get access to those tests while doing what they can to expedite efforts already underway.
“We can help scale to so many of these things,” Newman said. “We’re going to do what we can, whether the work needs a microphone, tech talent, process or money to help scale the efforts of the health systems who are doing a great job but have never faced anything of this scope before.”
Newman said he believes the COVID-19 online portal could be ready for initial use in the next 48 hours.
Newman is also heading up a system to put crowdsourcing strategies to work to locate and harvest health-related items that are coming up in short supply as supply chain issues continue to plague health care providers. He said items like swab kits and personal protective gear like masks and gloves are standard in many underused or unused labs, be they in schools or businesses, and believes these items could be identified with a concerted public outreach campaign and volunteer runners who can retrieve the items for use by those that most need them.
State Superintendent of Public Instruction Sydnee Dickson said Utah tech companies are playing a critical role in helping ensure students across the state, who began a two-week soft closure on Monday, have the technical resources they need to continue to engage with remote instruction efforts.
“I think the tech community has been amazing about giving free access and free services,” Dickson said. “We’re thinking about things like Wi-Fi for the kiddos and ... does everybody have access. The tech community has really stepped forward to say this is about community not about profit.”