The bumpy journey to efficient private lab testing

In late 2019, a new Coronavirus strain emerged around Wuhan, China, called Covid-19. Covid-19 was officially declared a Pandemic by the WHO on March 11, 2020. As the world struggled to learn about this new disease, both detection and treatment became critical. The journey to effective and efficient lab testing has been a bumpy one, with several barriers to overcome.

In many cases, scientists and private labs expressed frustration as the CDC seemed to struggle with providing an accurate test. Covid-19 is the first worldwide pandemic to test our laboratory systems in the modern era. As we look in hindsight, many lessons can be learned from this experience that can translate to better preparedness and more streamlined processes in the future.

Dr. Anthony Fauci, the nation’s top infectious disease expert, testified to Congress “The system does not, is not really geared to what we need right now. Yes, it is a failure, let’s admit it.”

The First Testing Hurdle

On January 7, 2020, the CDC begins planning for COVID-19 tests, including trying to get information out of China about the virus itself. On January 10, China published the genetic sequence of the virus, and the race was on to develop a test. On January 15th, the first known infected US citizen arrives in Seattle, and the CDC announced that tests would be made available to all health departments. At the same time, a scientist at U of Washington and several others were working on designing a test. The CDC test confirms the first case on January 20th. The CDC was using the test in its Atlanta labs, but could not send it out to public health labs until FDA approval.

The First Testing Hurdle

On January 7, 2020, the CDC begins planning for COVID-19 tests, including trying to get information out of China about the virus itself. On January 10, China published the genetic sequence of the virus, and the race was on to develop a test. On January 15th, the first known infected US citizen arrives in Seattle, and the CDC announced that tests would be made available to all health departments. At the same time, a scientist at U of Washington and several others were working on designing a test. The CDC test confirms the first case on January 20th. The CDC was using the test in its Atlanta labs, but could not send it out to public health labs until FDA approval.

Declaring a Public Health Emergency

On January 31st, Health and Human Services Secretary Alex Azar announced a Public Health Emergency. This declaration was a pivotal point for private lab testing. A public health emergency did two things to the lab approval process:

  1. Gave the FDA permission to speed up approval for critical medical products, like the CDC test being used in Atlanta.
  2. Mandated FDA approval – an Emergency Use Authorization – for scientists in university and commercial labs, research centers, and hospitals. Typically, these labs are permitted to make and use their own tests without government approval.

In effect, the Public Health Emergency declaration sped up the CDC lab approval process and hindered the process for private labs.

FDA Approvals

The FDA approved the CDC test on Feb 4th, 2020. At this point it is the only accepted test for Covid-19. Several states began receiving testing kits 4 days later. Unfortunately, a problem with one of the testing chemicals made the kits useless. Meanwhile, other countries were deploying their own tests in significant numbers.

The EUA Bureaucracy

Private teams at respected programs like the Mayo Clinic and the University of Washington continued to work quickly on testing, but met obstacles in navigating the FDA Emergency Use Authorization, a process they had not previously been required to engage in. On February 24th, the Association of Public Health Laboratories officially requested a relaxation of FDA rules

Public health officials soon realized that the public health laboratories would never be able to provide enough testing to meet demand. On Feb 29, the FDA issued guidance that labs certified by CLIA to perform high-complexity testing could use Covid-19 tests while they pursued an Emergency Use Authorization with the FDA. The intent of this was to speed up testing and increase capacity.

The first private test went live on March 2 at the University of Washington.

Admitting Failure

On March 12, Dr. Anthony Fauci, the nation’s top infectious disease expert, testified to Congress “The system does not, is not really geared to what we need right now. Yes, it is a failure, let’s admit it.”

Testing Status Today

As of July 2020, Coronavirus testing in the US has made huge strides to meet demand and continues to develop. Home testing kits are now available, and testing sites are easy to find. The emergency procedures that were in place at the beginning will undoubtedly be revised to meet future demands. A good starting place would be routine collaboration between the government and the private sector to meet common goals.