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July 9, 2021

FDA OKs direct-to-consumer COVID-19 saliva test for people age 5+

PHOTO | CONTRIBUTED
By Michelle Tuccitto Sullo

Branford-based Wren Laboratories has secured an expanded emergency-use authorization from the FDA for its COVID-19 saliva test.

The latest approval means the test will now be available directly to consumers and can be used to test for COVID in individuals ages 5 and up.

The company first garnered FDA approval to sell the COVID saliva test in the fall. 

According to the company, this latest FDA approval will expand the reach of its test kits to both consumers and schools. Its authorized use for children ages 5 and up is particularly timely as many schools are preparing to fully reopen in the fall.

Mark Kidd, laboratory director for Wren Laboratories, said the company has heard from several school districts about the need for a widely available saliva test which can be used on children as young as 5, who can’t be vaccinated yet. 

“It will help facilitate the nation’s much-needed fall reopening,” Kidd said.

According to Kidd, the test can detect all known variants in both symptomatic and asymptomatic people.

The product will also help as workers return to their jobs full-time. It is available over-the-counter and can be purchased online without a prescription. The test requires the collection of a teaspoon of saliva, and is less invasive than nasal swabbing, according to Wren.

The company said it can deliver digital results to customers within 24 hours of receiving a sample.

Contact Michelle Tuccitto Sullo at msullo@newhavenbiz.com.

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