“The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we have been asked to pause testing until we receive that additional authorization,” SCAN said. Bill Gates has also privately funded SCAN, according to the foundation. “We have been notified that a separate federal emergency use authorization is required to return results for self-collected tests,” SCAN said. SCAN said it did not have an update on specific timing for when testing would restart. Separately, the FDA on Saturday approved a standalone at-home sample collection kit for Everlywell Inc, a health and wellness company, which launched its kit in March.

Source: Dhaka Tribune May 16, 2020 19:52 UTC