Framingham company hopes FDA will approve its at-home test for kids

FRAMINGHAM, Mass. — A Framingham-based company is seeking FDA approval for its at-home coronavirus test to be used on children six and older.

EmpowerDX has been selling large numbers of its at-home PCR test since the fall and processing tens of thousands of samples every day.

The PCR test, rated by the FDA as one of the most accurate on the market, picks up symptomatic and asymptomatic cases.

The test – sold on the company’s website and Amazon - comes with a swab, special packaging and prepaid overnight return postage.

“It is very simple. You swab both of your nostrils a couple of times and then you put it in a saline tube and send it back to our lab,” said Delia Vallejo, Vice President and General Manager of empowerDX.

The test offers results in 24 to 48 hours.

According to Vallejo, it’s one of two at-home tests that processes insurance if purchased on the company’s website.

“You either need to have known exposure, mild symptoms or live in an area of community spread,” said Vallejo. “Since the virus is so spread out, essentially everyone in the country is living in an area of community spread.”

At the moment, the test is only covered by insurance for people 18 and older.

Vallejo said the company is hopeful that the FDA will approve it for children in the “very near future”.

She believes the test could be a helpful tool as more kids return to school.

“Children are still not qualified for the vaccine so we will need to continue to test children. That is very important to keep the schools open,” she said.

Only about 10 percent of the total U.S. population is currently vaccinated.

Some health experts say at-home testing is one of the easiest ways to slow the spread of coronavirus.

“I think it’s going to be something we are going to need in the foreseeable future,” said Dr. Brian Cruz, Regional Medical Director for PhysicianOne Urgent Care.

Dr. Cruz said at-home testing could prove to be important in returning to some sense of normalcy and keeping people at ease.

“At lot of people are going to wonder, if I have the sniffles or congestion… is that coronavirus?,” added Cruz. “A lot of these testing centers aren’t open 24/7. This allows people to do it right away without having to travel or make an appointment.”

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