Scanwell tries to provide 15-minute coronavirus tests for U.S. families but still needs FDA approval

Home diagnostic start-up Scanwell is working to deliver home testing tools for the new coronavirus to U.S. residents. The technology was developed by InNOVITA, a Chinese diagnostic technology company, and has been approved by the Chinese equivalent FDA and has been used by millions of people in China, and can be used at home within 15 minutes through telemedicine under the guidance of a medical professional, with results within hours.

Scanwell’s testing will need FDA approval, but the company told me it is in the process of securing approval through the FDA’s accelerated emergency certification program. FDA guidelines say the approval process should take 6-8 weeks, and Scanwell’s goal is to be ready to ship it to U.S. users once it is approved. Although the U.S. Drug Enforcement Administration previously included ONLY PCR testing in its protocols, it updated the guidelines earlier this week to include serological testing. Scanwell further said it did not expect any problems with FDA approval.

The Scanwell test uses a “serological” technique that can look for antibodies in a patient’s blood. These will only exist after someone has been exposed to the SARS-CoV-2 virus, because so far, researchers have found no evidence that natural antibodies to this particular virus can exist without exposure. In contrast, the type of test currently used in the United States is the “PCR” test, which uses a molecular-based method to determine whether the virus is genetically present in mucus samples.

Technically, PCR type testing is more accurate than serological testing, but serological detection methods are easier to manage and produce results faster. Overall, it’s also very accurate and much cheaper than the PCR version. In addition, it can not only test the most severe cases of symptoms only, but also expand the scope of work, and better illustrate the entire virus, including those with mild illness who have recovered at home, as well as those who are asymptomatic but may be infected with the virus.

In addition, while PCR testing is already available at home, it requires round-trip test samples, increasing time, complexity and cost, and relying on test materials such as cotton swabs to make the materials in short supply worldwide. Therefore, once the test is available, people who are considered qualified through the Scanwell Health mobile app will get the test tool. They will be tested under the guidance of a licensed doctor and a licensed nurse at the telemedicine partner Lemonaid, and will receive the results and further guidance on them within hours through the mobile app. The cost of the entire testing process is $70.

Scanwell tries to provide 15-minute coronavirus tests for U.S. families but still needs FDA approval