FDA approves 4 Covid-19 test kits

A close up shot of Coronavirus 2019-nCoV an infectious flu virus which causes respiratory illness. Human blood samples in a medical lab. 3d illustration concept

A close up shot of Coronavirus 2019-nCoV an infectious flu virus which causes respiratory illness. Human blood samples in a medical lab. 3d illustration concept

The U.S. Food and Drug Administration took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and LabCorp for its COVID-19 RT-PCR test. The company is also trying to see if it can provide them free of charge in partnership with government and public health partners. "Given the high demand for testing, the company will work rapidly to make more tests available as the global supply shortage for COVID-19 diagnostic kits is addressed".

The new measures, among other things, call for states to take responsibility for tests used by labs in the respective states. Thermo Scientific also received authorization to distribute its real-time PCR (RT-PCR) diagnostic kits on March 13 and plans to produce 5 million of those tests a week by April. The Guidance contains policies regarding (i) laboratories' development and use of certain tests prior to or without an Emergency Use Authorization (EUA), (ii) commercial manufacturers' development and distribution of certain tests prior to an EUA, and (iii) development, use, and distribution of serological tests without an EUA. Both tests are for the qualitative detection of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). However, if FDA, upon review of the EUA request, identifies a significant problem that can not be addressed in a timely manner, the laboratory may have to stop using the test and issue test reports indicating that prior tests may be unreliable. In addition, more than 30 laboratories have notified FDA that they are testing, or intend to begin testing soon, laboratory developed tests (LDTs) for COVID-19.

"We are taking steps to support diagnostic development considering the urgent need", Hahn said in a statement. "We urge the state authorities and commercial developers to take all necessary steps to ensure the availability of accurate tests". However, it should be noted that the manufacturer may have to suspend distribution and recall its products if, upon review of the EUA request, FDA identifies a significant problem that can not be addressed in a timely manner.

Amazon confirms the first known COVID-19 case in a U.S. warehouse
As of Thursday morning, there have been more than 222,000 reported cases of COVID-19, including at least 9,400 in the U.S. In a statement to Fox News, an Amazon spokesperson said they were providing help to the unnamed individual.

Since the end of January, the FDA has being working with more than 100 diagnostic test developers.

The changes upend the traditional regulatory pathway by which the FDA reviews medical devices and diagnostics.

Recommended News

  • New Zealand decriminalises abortion

    New Zealand decriminalises abortion

    That resulted in delays to access a procedure, and that was less safe. "The next stage is making sure it's implemented". The decriminalisation of abortion was a win for Prime Minister Jacinda Ardern and her center-left coalition party.
    Facebook Gives $100m To Small Biz To Offset Impact Of Coronavirus

    Facebook Gives $100m To Small Biz To Offset Impact Of Coronavirus

    For this crisis, all false information is down. "If it's harmful and it's fake, it's down". A politician says something, he executes it in an advertisement, he says it in a speech.
    Social Distancing Leads To Blood Shortage

    Social Distancing Leads To Blood Shortage

    Blood banks are asking healthy donors to turn out "in full force" as donations drop in the face of the spreading coronavirus . Vitalant officials said all blood types are in demand, with a significant need for platelets and Type O blood donations.
  • Katy Perry Wins Dark Horse Appeal

    Katy Perry Wins Dark Horse Appeal

    LOS ANGELES, CALIFORNIA - MAY 19: Katy Perry attends ABC's " American Idol " Finale on May 19, 2019 in Los Angeles, California. Yesterday (March 17), a federal judge in Los Angeles overturned a ruling that Perry and stable of collaborators - including Dr.
    Giants agree to terms with S Nate Ebner

    Giants agree to terms with S Nate Ebner

    The 31-year-old also is a star rugby player who competed for Team USA's rugby sevens squad at the 2016 Summer Olympics in Rio. It's a natural fit for Ebner, as Giants head coach Joe Judge was his special teams coach for eight seasons in New England.
    Who's using Google and Facebook data in coronavirus fight?

    Who's using Google and Facebook data in coronavirus fight?

    But it is unclear whether the Trump administration has asked them to provide that data, and if so, how granular it might be. Since then, it has been used to track the spread of cholera in Mozambique and to help improve vaccination rates in Malawi.
  • Microsoft closes all of its stores due to coronavirus risk

    Microsoft closes all of its stores due to coronavirus risk

    Other platforms have also pledged to work quickly to remove any misinformation flagged to or spotted by them which is linked to the virus.
    Organizers Cancel 2020 Eurovision Song Contest In Rotterdam Due To Coronavirus

    Organizers Cancel 2020 Eurovision Song Contest In Rotterdam Due To Coronavirus

    Earlier on Wednesday, the organizers of the Glastonbury music festival said they were calling the event off this year. For the first time ever, the annual global singing competition Eurovision has been canceled.
    Monaco’s head of state Prince Albert II tests positive for coronavirus

    Monaco’s head of state Prince Albert II tests positive for coronavirus

    The palace said Albert's health "does not inspire any concern", saying he was continuing to work from his private apartments. He will be monitored by his doctor and specialists from the Centre Hospitalier Princesse Grace, but is not in hospital.
  • Darius Slay becomes Eagles' $50 million splash after Lions trade

    Darius Slay becomes Eagles' $50 million splash after Lions trade

    Jim Schwartz has been hesitant to do that in Philly, but that's likely because he hasn't had a cornerback of Slay's caliber. The Detroit Lions have reportedly traded Pro Bowl defensive back Darius Slay to the Philadelphia Eagles .
    Christmas lights go back up, offer hope and solidarity

    Christmas lights go back up, offer hope and solidarity

    The airport worker says it was reading about social isolation on Facebook that sparked the idea to have a second Christmas. You don't need to be right about your feelings on this whole thing.
    Campaign follows Trump's lead, hitting China and Biden amid coronavirus crisis

    Campaign follows Trump's lead, hitting China and Biden amid coronavirus crisis

    Abe hasn't decide whether to cancel the games, Trump said, but "we'd live with his decision if he does". Trade Representative's office has recently granted seems to be a recognition of that fact.

We are pleased to provide this opportunity to share information, experiences and observations about what's in the news.
Some of the comments may be reprinted elsewhere in the site or in the newspaper.
Thank you for taking the time to offer your thoughts.