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The FDA is outsourcing COVID-19 testing to China
At least 10 Chinese companies have received FDA authorization for U.S. testing.
The U.S. Food and Drug Administration (FDA), which has come under fire for seemingly rubber stamping Emergency Use Authorization (EUA) for COVID-19 testing without offering virtually any data-driven or appropriate testing standards, has been delivering EUAs to China-based pharmaceutical companies at an alarming rate.
After reviewing the 161 emergency use authorizations granted by the FDA since February, I found that at least 10 Chinese companies were delivered the FDA stamp of approval to deliver diagnostic tests in the United States for SARS-CoV-2, which causes COVID-19.
These China-based companies have received FDA EUAs that grants them the ability to test for the coronavirus in America (including date of approval and link to FDA approval document):
China is the United States’ greatest adversary, and Beijing has not been forthcoming about the role it played in potentially negligently unleashing the novel coronavirus. These factors may cause many to raise concerns about the FDA’s decision to continue to authorize Chinese labs and companies to deliver U.S. coronavirus testing. Moreover, China’s one-party, top-down totalitarian system demands that corporations based in China are completely subservient to the state. There are no truly independent companies in China. All are ultimately beholden to the needs of the Chinese Community Party (CCP).
The U.S. and global coronavirus testing regimes have recently come under intense scrutiny, after it became clear that the most common testing method, known as a PCR (polymerase chain reaction) test, has become completely unreliable in determining whether someone actually has the virus.
Almost every company authorized to do novel coronavirus testing with PCR instruments are setting a threshold that is far too high to accurately detect whether or not the patient actually has COVID-19.
Over at RationalGround.com, data analysts Jennifer Cabrera and Alex Rodriguez elaborate on this botched FDA standard:
“The FDA’s Instructions for Use for the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel currently recommends a threshold of 40 cycles for a specimen to be considered positive,” which is well above the recommendations of scientists and experts evaluating testing accuracy.
And while companies in the United States and abroad have continued to discover and research more innovative and accurate methods to determine the presence of live virus, notably, all 10 of the Chinese labs authorized by the FDA utilize PCR testing. The publicly available data on the China-based PCR tests shows a cycle threshold that is far too high to accurately determine test positivity.
When the FDA issues an EUA, it allows for these companies’ tests to continue to go out to labs and hospitals. EUAs are supposed to be granted only if a company can show that their test product is working to a high standard. But it is the FDA that is setting a poor testing standard that allows for companies to continue to produce poor data.
The FDA has been granted authority to extend EUAs for coronavirus testing since the Secretary of Health and Human Services issued a public health emergency declaration early this year in response to the pandemic.
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