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November 17, 2020

Branford lab gets FDA OK for COVID saliva test

PHOTO | CONTRIBUTED
By Natalie Missakian

A Branford-based lab has gotten the federal OK to sell a new saliva-based test it has developed that aims to help employers and others easily collect samples to test for COVID-19.

Cancer diagnostics company Wren Laboratories said it is marketing the test kit to businesses, schools, hospitals, nursing homes and others. 

It received emergency use authorization from the Food and Drug Administration late last month. 

Dr. Irvin M. Modlin, Wren’s medical and scientific consultant, said the test  is “simple to use in a workplace, school or home” and can be transported to the lab at room temperature.

“Testing continues to be in very high demand and we are pleased that Wren can contribute to the global fight against COVID-19,” he said in a statement.

The PCR test detects the virus’ genetic material and comes with a proprietary collection device that changes the sample’s color to reassure users that the collection was done correctly. 

Collection takes 1 to 2 minutes and can be done by the patient on their own, without a medical professional, the company said. 

The user then must mail the sample to Wren Laboratories and will usually get results within 24 hours after the lab receives it, according to the company. 

The test, including the self-collection device, costs $150, according to the company’s website. 

Saliva-based testing has been billed as a game-changer for detecting COVID-19. It is considered less invasive than traditional PCR tests, where a swab is inserted deep into the nasal cavity. 

Wren joins Yale University, which has also rolled out a saliva-based test developed by School of Public Health researchers, called SalivaDirect.  That test, which is being offered by specially certified labs around the country, does not require a special collection device.

Contact Natalie Missakian at news@newhavenbiz.com

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