FDA Looks to Help Ramp Up Testing for COVID-19 Across the US

Regulatory NewsRegulatory News
| 16 March 2020 | By Zachary Brennan 

As the US continues to trail other countries in COVID-19 testing capacity, the US Food and Drug Administration (FDA) unleashed the private sector over the weekend, granting Emergency Use Authorizations (EUAs) to Roche and Thermo Fisher Scientific in vitro diagnostics.

Roche’s cobas 6800/8800 Systems, which the company said are widely available, are used to perform the COVID-19 test and can provide results in three and half hours. The firm noted that the highest throughput could provide up to 96 results in about three hours.

Thermo Fisher, meanwhile, says it currently has 1.5 million tests available to ship under its EUA and expects to quickly ramp up to reach 2 million tests per week. The company expects to scale production “up to 5 million tests per week during the month of April. The available tests will initially be distributed to approximately 200 labs in the U.S. and Thermo Fisher will continue to work in partnership with government agencies and private partners to expand access,” Thermo said.

Two other lab testing companies - Quest Diagnostics and LabCorp – are also pursuing EUAs and ramping up testing. Quest said on Saturday that it expects to have capacity to perform approximately 10,000 tests a day by the end of next week and approximately 20,000 tests a day by the end of the month.

The American Clinical Laboratory Association added in a statement on Friday: “Once additional FDA-approved high-throughput testing is available on large diagnostic platforms next week, the industry expects its capacity to be increased to more than 20,000 tests per day. Assuming there are no delays or shortages of necessary materials and supplies, commercial capacity is expected to exceed 280,000 tests per week by April 1.”

The new and upcoming EUAs come as, according to the Centers for Disease Control and Prevention (CDC), as of the morning of 15 March, 84 state and local public health laboratories in 50 states, the District of Columbia, and Guam have successfully verified COVID-19 diagnostic tests and are offering testing. Puerto Rico and the Virgin Islands are still working to get testing up and running.

US public health labs took over the bulk of the testing from CDC labs on 27 February, according to CDC figures.
FDA on Sunday also slightly altered the previously issued EUAs for the diagnostics from the CDC and the New York State Department of Health’s Wadsworth Center to help expand test and component availability and reduce the time to final results, FDA Commissioner Stephen Hahn said Monday morning.

“Both authorizations reduce the need for confirmatory tests for these diagnostics, thereby helping to reduce the number of tests that need to be used per patient and helping to reduce the time of final result reporting,” Hahn added.

FDA further updated its frequently asked questions document to note some of the other commercial and health care/academic laboratories that have validated their own COVID-19 tests and begun patient testing as outlined in an FDA guidance from last month. Such facilities include:
  • AdventHealth
  • ARUP Laboratories
  • Baylor Scott and White Medical Center – Temple
  • BioReference Laboratories
  • The Children's Hospital of Philadelphia
  • HMH Hackensack University Medical Center
  • Hospital of the University of Pennsylvania
  • Johns Hopkins Medical Microbiology Laboratory at Johns Hopkins Hospital
  • Laboratory Corporation of America
  • Montefiore Medical Center
  • New York Presbyterian Hospital -Weill Cornell Medicine (NYPH-WCM)
  • NYU Langone Medical Center
  • Quest Diagnostics Infectious Disease, Inc.
  • Stanford Health Care Clinical Laboratory
  • Texas Children's Hospital Department of Pathology
  • UCSF-Health
  • University of Washington
  • Viracor Eurofins Clinical Diagnostics
Qiagen, BioMerieux and Abbott Laboratories have also indicated that they are working on diagnostics.

Other Measures

FDA also became aware of some shortages of personal protective equipment (PPE) last month, such as gowns and surgical masks, and has provided conservation strategies to health providers.

In addition, the agency said it’s interested in hearing from companies that might be able to mitigate such shortages.

And as shortages of hand sanitizer continue, FDA last week also issued guidance to allow for the temporary compounding of certain alcohol-based hand sanitizers by pharmacists and registered outsourcing facilities.


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