One of the hot topics concerning the COVID-19 crisis in the U.S. is that many experts feel that testing for the virus started too late and too few patients are getting tested. Testing important to guide treatment and make efficient use of stressed healthcare resources. It is also essential for epidemiologists to get a handle on how rapidly the disease is spreading, what portion of the population is infected, and what the rates of acute illness and death are. More help may be on the way.
Scanwell Health makes a home test for urinary tract infections (UTIs) that relies on your smartphone to scan a test strip. The company can also arrange for same-day prescription of antibiotics if a customer’s test returns a positive result. Scanwell recently got the rights to license and distribute a COVID-19 test designed for home tests. (To be precise, it’s a “SARS-CoV-2” serology test.
The test is cleared by the Chinese equivalent of the FDA, and is manufactured by INNOVITA, a Chinese biotech company. It works by detecting antibodies in the blood that indicate that the person has been exposed to the virus. The system will start with an online questionnaire, and if the patient qualifies, a test kit will be sent out for next-day delivery. The home test takes about 15 minutes to complete, and results will come back within a matter of hours. The FDA recently updated its guidance to include serological tests.
Scanwell is seeking an Emergency Use Authorization (EUA) from the FDA and hopes to start delivering test kits 6 to 8 weeks after that. Initially, the company plans to provide tests to the states hardest hit by the virus, including New York, Washington, and California. If this test receives clearance from the FDA, it could provide a valuable tool to test patients in their own homes, which would take some of the load off the stressed healthcare system resources.