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Scanwell Health Licenses At-Home SARS-CoV-2 Rapid Test, Prepares Launch

NEW YORK – Scanwell Health announced Thursday it has secured exclusive rights to license and distribute a SARS-CoV-2 rapid serology at-home test from Chinese biotechnology firm Innovita.

Financial and other terms of the deal were not disclosed.

The test detects IgM and IgG antibodies against SARS-CoV-2 in the blood, which indicates a patient has been exposed to the virus and developed antibodies against it. It can identify infected patients as well as asymptomatic carriers and is the only rapid serology test cleared by China's National Medical Products Administration that detects and displays both IgM and IgG antibodies in blood, the Los Angeles-based company said.

Innovita's test has been used extensively in China to diagnose the virus, and clinical trials found 87.3 percent sensitivity and 100 percent specificity when compared to traditional tests, the company added.

The 15-minute test can be completed using the Scanwell Health app, with a healthcare provider reaching out to the patient within hours to discuss results and follow-up care. Scanwell said it will use its existing partnership with telehealth app Lemonaid Health to distribute the test.

Scanwell's announcement comes after guidance from the US Food and Drug Administration earlier this week expanding protocols for SARS-CoV-2 testing to serological tests. 

“While the gold standard for diagnosis is still the PCR test, given the growing shortage of swabs and reagents, a rapid serology test is beneficial in that it allows for wide-scale testing,” Scanwell Health CEO Stephen Chen said in a statement. “We hope that these home-use test kits will ease the burden on healthcare centers, so that they can focus on the highest severity cases." 

The company said it anticipates the kits will be available in six to eight weeks after Scanwell receives Emergency Use Authorization from the FDA, and the test will cost $70 with no insurance required. Scanwell also said it is looking at options for patients who can't afford to pay. The test will roll out in severely affected states first, such as Washington, California, and New York, the company said.