A home coronavirus testing program was halted by the US Food and Drug Administration (FDA) because researchers were not allowed to give back test results to doctors or patients.
This at-home coronavirus project is supported by the Bill and Melinda Gates Foundation for the current COVID-19 problem in the US.
As an alternative to testing by official agencies, the Seattle Coronavirus Assessment Network (SCAN) was offered as home testing for residents, but until the FDA approves it, the project will be on hold for the meantime.
No problem with accuracy of SCAN
The FDA initially allowed testing done by the SCAN, but only at the discretion of the researchers. They later found out that the researchers were sharing test results to the patients, which violated the surveillance-only purpose of the home testing kits.
Maybe this was overlooked by the researchers but the FDA specifically indicated all test were for surveillance only. This violation would soon be explained in detail by the FDA.
When asked to explain why the SCAN was temporarily stopped, the official was clear that the suspension of testing was not because of safety or how accurate were the obtained results. There were about 300 people a day who were tested for COVID-19.
In a statement on why the SCAN was shutdown, the FDA was clear they had no problems with safety or accuracy of the protocols used. SCAN administrators added that testing was stopped until extra authorization was granted by the FDA for this express purpose.
Since March, all technical assistance is given by the Gates Foundation to SCAN that had additional approvals from Washington regulators.
Informing patients of SCAN results are not part of the deal
In March of this year, Seattle had the most coronavirus cases in the US, adding the terrible COVID-19 outbreak at the Life Care Center nursing home in Kirkland, a suburban part of Seattle. Money came from the Microsoft founder to fund SCAN, this is according to the foundations.
According to Microsoft Billion, a post on May 12 made it clear that scan is not to replace widespread testing, instead should the extent of the COVID-19 how it has moved through a community. It shows how much risk there is for all.
Gates explained that SCAN is an extended program of the 2018 Seattle Flu Study, a study that tracked influenza in 2018-2019.
Information came out, on Thursday that SCAN has been in touch with the FDA on March 1 and asked for emergency use authorization (EUA) in March 23, with the data to be surrendered in April 13. Special authority is needed to allow returning results to patients, if there is not then it cannot be done.
An FDA spokesman told FOX business that the FDA agrees with at-home testing for COVID-19, but the data should be along acceptable parameters.
The FDA made it clear that they thought SCAN was just a study to check the extent of the COVID-19 infection. Telling patients the result is not part of the agreement. SCAN will inform the public when the Bill Gates Home Coronavirus Testing Program will get extra authority to restart.