FDA approves COVID-19 test kits from China and South Korea

Katie Ramirez
March 20, 2020

Plus, if people have the option of testing at home, they won't have to venture to the hospital and potentially expose people to COVID-19 while they're out, according to the paper.

"We ask the public and stakeholders to be analytical of COVID-19 test kits that they may encounter as we have identified some applications which appear to be suspicious and unauthorized", he said.

However, authorities are moving quickly to close that gap and ramp up testing capacity.

Hahn said the FDA has engaged with more than 100 test developers since the end of January and provided templates and advice about the process.

States will now be able to authorize the use of specific tests without the laboratories having to engage with Washington.

Earlier this week, the FDA updated its guidance on testing for the novel coronavirus (COVID-19), allowing clinical laboratories to create and perform COVID-19 tests without pursuing FDA emergency use authorization (EUA).

Coronavirus Shows Signs of Slowing in China
The report also stated that there have been just 34 new cases of COVID-19 across all of China - all of whom came from overseas . There were 0 new suspected cases (0 in Wuhan) and 0 existing suspected cases (0 in Wuhan).

In a statement, FDA Director General Eric Domingo said that the companies have complied with the requirements as stated in the FDA Memorandum 2020006 entitled, "Issuance of Special Certification for Imported Test Kits of Covid-19".

With respect to allowing states to regulate diagnostics, Hahn said that the policy would only extend to those states that wish to take on oversight themselves, like NY.

It is the third EUA granted by the USA regulator during the current outbreak of the COVID-19 virus. "This clearly runs counter to the FDA's new guidance, and we at AACC are working intently with legislators to fix this and to ensure that all patients have access to COVID-19 testing". Thermo Fisher Scientific and Roche Molecular Diagnostics were the first commercial developers to receive the go-ahead late last week. As of Monday March 23, it'll also offer a COVID-19 sample collection kit for home use. The FDA said the change extends to other states the authority the FDA gave last week to the New York State Department of Public Health to approve diagnostic tests within the state.

In an advisory, they clarified that the four are "PCR kits used in laboratories, and not point-of-care-kits". Though manufacturers now have the go-ahead to develop serological tests, which measure the amount of proteins or antibodies responding to infection in a patient's blood, it's unclear how many developers will choose to do so.

The new changes demonstrate the extent to which the FDA is willing to sweep away barriers to getting more tests into the field, while still maintaining some of its oversight responsibilities.

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