Editor’s Note: On March 21, the U.S. Food and Drug Administration updated its Emergency Use Authorization guidelines. The announcement barred private labs from collecting at-home samples from customers. As reported by TechCrunch, this means startups such as Assist Health have to discontinue their testing programs immediately.
A Farmers Branch medical startup called Assist Health Group launched a program Monday morning offering a simple oral swab test that people can use at home for the COVID-19 virus. The public quickly overwhelmed the startup with requests and by Monday afternoon, they were out.
A waitlist was put in place, but by Wednesday the effort was halted.
Assist Health Group Director Ali Poonawala told Dallas Innovates getting more swab kits had become a struggle. “It’s a pretty dire situation and I wish I had better news,” he says.
Poonwala said late Wednesday that Assist Health Group had stopped sending out kits and also stopped accepting orders.
He said that was the result of the company receiving two pieces of news. While the FDA has expanded the kind of swab kits that could be used for specimen, solving the problem of the kits being out of stock, the agency issue the guideline “not recommending” at-home specimen collection.
He said that kits already sent out are going back to the lab. On that front, he said the FDA also issued the following guidance.
“To avoid specimens being wasted, if a lab is presented with a specimen that was collected or identified in a sub-optimal manner, e.g. with a swab for which there is less evidence of effectiveness, FDA believes that it would still be appropriate for the lab to accept the specimen for analysis and note the circumstances on the report.”
The launch was the result of aggressive efforts nationwide to increase diagnostic testing and stem the virus’ spread. Assist Health is working with national labs to provide the testing.
“People need access to testing without the fear of infecting others,” Poonawala says.
Under the Assist Health program, patients could elect to have kits sent to Quest Diagnostics or Labcorp for testing at no cost.
Assist Health was able to get some swabs to peopl it has been receiving between 10 and 20 swabs back each day—and has sent them out as soon as possible.
“Even after putting up the out-of-stock note, we still continue to receive requests and calls,” he says.
Some people wanting swab kits have stories to tell—and a sense of urgency—such as one man who had a critical medical need.
“The gentleman had only one lung and had been sick for a few days now,” Poonawala says. “He was unable to get a test through his doctor. He had called the Dallas Health Department and a number of other places before calling us and was told he did not meet the criteria.”
Poonawala says the man told him: “I don’t want to wait until I have shortness of breath to get tested because with one lung I think it would be too late to do anything. I need to know now.”
Assist Health sent a kit on Monday to another Dallas resident with a similar story. The woman had lung cancer previously and had a fever, but was told she didn’t meet the criteria for testing.
Testing by certified labs made easier by government
Assist Health said once the kits were requested, the company sent them to individuals within one day of ordering and they contain everything necessary to return specimens to the lab overnight for development. A prepaid envelope and cold pack were provided to return specimens to the lab. Results were to come in three to four days, Assist Health says.
“I really think this is the best way to screen patients,” Poonawala says. “It allows us to reach individuals without risking transmission because they don’t have to leave home. It doesn’t expose our healthcare workers to unnecessary risk, and also reduces the load on our ERs and healthcare systems.”
In fact, Assist Health said home tests will help keep all types of establishments safe from the coronavirus outbreak.
Everlywell offers testing kits for sale
Last week, we told you about Dallas native Julia Cheek’s home health testing company Everlywell offering at-home tests for COVID-19.
Everywell, an Austin-based company that was originally founded in Dallas launched validated at-home testing kits for general wellness, women’s and men’s health, energy and weight, sexual health—and now, COVID-19.
But on March 21, the U.S. Food and Drug Administration updated its Emergency Use Authorization guidelines.
The announcement barred private labs from collecting at-home samples from customers. As reported by TechCrunch, this means startups like Carbon, Health Nurx, and Everlywell had to discontinue their testing programs immediately.
As of March 23, Everlywell said on Twitter it is still committed to making a COVID-19 test available to consumers. The team is “encouraged by the most recent WH briefing,” and is “actively working with the FDA on a path forward for COVID-19 sample self-collection in a home setting.”
Right now, its COVID-19 test is only available to qualifying hospitals and healthcare companies that provide the test for free to healthcare workers and symptomatic patients.
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