FDA to allow states to authorize coronavirus tests

Katie Ramirez
March 19, 2020

"FDA grants an EUA for Roche's coronavirus test". "However, we are concerned that insurance will not cover these new tests under the Families First Coronavirus Response Act as it is now written". We laboratory directors were on the spot to develop tests, and most were unprepared to say the least. "The FDA is actively reviewing and discussing the application as we speak". "We are confident in our ability to meet the growing demand for this diagnostic", Egan added.

The results of the test will then be sent by text or email, according to Time.

Efforts to tally USA testing figures have been stymied by the fragmented nature of the country's health system, split between federal, state and local efforts and the private sector. They estimated that 59,000 people in the USA have been screened for the virus since January, split roughly between government and industry labs.

In fact, health experts are also on board for home coronavirus testing in the U.S. In a recent paper published in JAMA Health Forum, two doctors laid out the possible benefits of making these at-home tests available.

Countries in Europe and Asia have been using drive-thru testing for weeks to screen thousands of people. FDA granted the authorizations within 24 hours of receiving the requests. The labs do not have to engage with the FDA nor will they need to apply for Emergency Use Authorization (EUA). The agency finally reversed course late last month after an outcry from state and local labs frustrated by the lack of testing options. "We urge state authorities and commercial developers to take all necessary steps to ensure the availability of accurate tests".

China expels U.S. journalists working for NYT, WSJ and Washington Post
The reasons cited include increasingly harsh surveillance, harassment and intimidation of American and other foreign journalists working in China.

We are taking steps to support diagnostic development considering the urgent need. For most people, the new coronavirus causes only mild or moderate symptoms. Although there are drugs in development and testing phases, there are no drugs now available that are proven effective against severe coronavirus illnesses. However, now that more labs are going to be offering tests without EUAs, it is crucial that Congress amend language in the Families First Coronavirus Response Act which, as currently drafted, does not provide coverage for COVID-19 tests without EUAs.

Every year, the FDA conducts almost 500 inspections in China, and the maximum of these inspections are for medical devices, drugs and food products. Additionally, most state systems are already struggling to respond to the outbreak. We laboratory administrators have been abruptly competing with one some other for restricted sources to expand those exams. Part of the prolong was once because of what came about throughout the Zika virus outbreak of 2015, when laboratories that advanced their very own exams have been halted by means of the FDA as a result of they didn't have approval.

Over 156,000 people have been infected globally.

Even as regulators loosened their standards for state and commercial tests, new challenges emerged.

FDA officials said they are working to find new suppliers and alternative products. Health care providers are also seeing dwindling supplies of basic equipment needed to test patients, such as swabs and protective masks. Last week, the agency set up a toll-free number for lab staff seeking help with supplies.

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