by Brian Shilhavy
Editor, Health Impact News
The CDC quietly announced last week that it was withdrawing its request to the FDA for Emergency Use Authorization (EUA) of the 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2.
Most of the public is probably unaware that similar to the current COVID-19 injections that are not yet approved by the FDA, but only given Emergency Use Authorization, so too the hundreds of diagnostic tests that supposedly detect COVID-19 are also NOT approved by the FDA, but only authorized via an EUA.
What is the reason the CDC is withdrawing its EUA request for the Real-Time RT-PCR Diagnostic Panel?
In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test.
CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. (Source.)
Caitlin McFall, writing for Fox News, is the only one in the corporate media I could find that even reported this, and the few reports I found in the Alternative media so far have been mostly inaccurate.
The Centers for Disease Control and Prevention (CDC) urged labs this week to stock clinics with kits that can test for both the coronavirus and the flu as the “influenza season” draws near.
The CDC said Wednesday it will withdrawal its request for the “Emergency Use Authorization” of real-time diagnostic testing kits, which were used starting in February 2020 to detect signs of the coronavirus, by the end of the year.
“CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives,” the agency said.
The U.S. has reported more than 34.4 million cases of the coronavirus since the pandemic began in 2020 and more than 610,000 deaths.
But while cases of COVID-19 soared nationwide, hospitalizations and deaths caused by influenza dropped.