The handheld device sends data via a mobile app to a cloud-based service, which provides a test result within a few seconds.
A Tampere-based medical devices company has received an EU-wide CE certificate for the distribution of a rapid Covid-19 breath test.
CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements.
“We are driven to provide a disruptive Covid screening solution that helps individuals, families, and communities return to normal at work, school, and play,” CEO Pekka Rissanen of Deep Sensing Algorithms, which developed the product, said in a company press release.
Speaking to Yle on Monday, Rissanen confirmed that the company now has permission to sell the device within the EU, adding that the rapid Covid breath test will be the first of its kind to enter the commercial market.
Yle first reported on the development of the device last February. It garnered significant interest at the time as it provides results quite quickly and would be especially useful for screening by border guards or at airports.
Test subjects blow into the handheld device, where nanosensors analyse their breath. The data is then sent via a mobile app to a cloud-based service which provides a test result within about 45 seconds.
“The human defence mechanisms start immediately after the infection and the metabolic byproducts of the person’s immune response start to appear in exhaled breath within the same day,” the company explained in the statement.
The device is manufactured in Turku, but the quantity produced will depend on orders.
“I can’t provide a revenue forecast at this point. The business model is in two parts, we get money for the device and from how much it is used,” Rissanen explained, but added that production is currently hampered by a global shortage of components.
“The situation is very challenging,” he said.
The breathalyser must be used by a professional as it is officially a medical device.
“Occupational health care, school health care and dental care would be good places for the device,” Rissanen said.
