Co-Diagnostics CEO: FDA emergency use authorization for coronavirus test allows ‘great accessibility’
Co-Diagnostics CEO Dwight Egan discusses his company’s COVID-19 tests, which have received FDA emergency use authorization.
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The United States' shortage of novel coronavirus test kits is the result of rapidly increasing demand met with a weak national supply chain and disruptive federal regulations.
The Department of Health and Human Services (HHS) Office of the Inspector General interviewed 323 hospitals across 46 States in March and issued a report Monday that found most U.S. hospitals are experiencing testing shortages and extended wait times for test results.
"Key to the success of a whole-of-America approach to combating COVID-19 is working with our state and local partners to make sure America's healthcare providers have the tools and the resources they need to take care of patients – including spurring private industry to ramp up production of needed materials," an HHS spokesperson said in a Monday statement.
A laboratory technician handles micro centrifuge tubes containing patient samples to be tested for the new coronavirus that causes COVID-19, at the Pathologists Lancet Kenya laboratory in Nairobi, Kenya. (AP Photo/Brian Inganga)
A shortage of COVID-19 test kits is similarly a direct result of rapidly growing demand for COVID-19 kits and a "shortage of physical components" needed to make the tests, The New Yorker reported on March 24.
CORONAVIRUS PUSHES CVS TO LAUNCH TWO NEW DRIVE-THROUGH TESTING SITES
The physical components in question include virtual transport media, which are used to safely transport a specimen taken from a patient to a lab; extraction kits, which isolate viral RNA from biological samples; reagents, which are substances or compounds added to a sample to determine whether it contains COVID-19; and test swabs, according to The New Yorker.
The test component shortage is the result of global demand met with factories that were shut down due to COVID-19, as well as complications with operational factories that simply cannot keep up with orders, the outlet reported.
A worker verifies a coronavirus drive-thru testing appointment at a Vehicle Emissions Inspection Program station in Curtis Bay, Md., April 1. (AP Photo/Susan Walsh)
The U.S. is also experiencing a shortage of certain potential COVID-19 treatment medications because generic drug manufacturing is dominated by China, where some factories have been closed due to COVID-19, thus slowing production, even as demand is at an all-time high.
Nearly 1.4 million people worldwide have tested positive for the virus, including 368,449 people in the U.S. Experts suggest numbers would be higher if COVID-19 tests were more widely available.
President Trump on March 4 blamed Obama-era supply-chain regulations for the country's current production issues.
WHAT IS A SUPPLY CHAIN?
"The Obama administration made a decision on testing that turned out to be very detrimental to what we're doing, and we undid that decision a few days ago so that the testing can take place in a much more accurate and rapid fashion," Trump said during a White House briefing.
The president was referring to 2004 Food and Drug Administration regulations that prevent medical laboratories from using diagnostic tests to clear their own medications. Instead, the law requires those labs to receive "Emergency Use Authorization" from the FDA, which has significantly slowed test production, according to Politifact.
While the regulations were meant to speed up the clearance process for medical labs, researchers reported long wait times between requesting applications for EUAs and receiving approval, the fact-checking website found.
WHICH SUPPLY CHAINS HAS CORONAVIRUS AFFECTED THE MOST IN THE US?
The Trump administration has rolled back these regulations in an effort to speed up test and treatment production.
The FDA has granted 28 EUAs for COVID-19 tests since February and says EUAs are not a barrier to testing.
University of Michigan Department of Industrial and Operations Engineering Professor Mark Daskin and Ph.D. candidate Emily Tucker published a study in late March on how the U.S. can prevent drug shortages and then wrote a follow-up article for global news outlet The Conversation explaining their findings.
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Daskin and Tucker note that a combination of test-kit demand and medication demand could result in overall shortages even if supply is unaffected by plant shutdowns.
To combat these shortages of test kits and medicines, people should partake in social distancing to lessen demand, and the government and pharmaceutical companies should consider extending some drug expiration dates if possible.
Additionally, the U.S. should revisit medical regulations, decentralize production facilities and consider allocating more resources to manufacturers to speed up production, the study notes.
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