A report from the Government Accountability Office (GAO) catalogues the Centers for Disease Control and Prevention’s (CDC) failures that contributed to numerous problems with SARS-CoV-2 testing during the COVID-19 pandemic and makes recommendations for how the agency should overhaul its strategies.

A top recommendation is that CDC develop a plan with stakeholders to improve surge capacity for testing. This plan should cover timelines, agency and stakeholder roles and responsibilities, gaps from preparedness exercises, and more.

Key to the surge capacity plan will be a way to improve preparedness for test kit manufacturing. “Establishing contracts with test kit manufacturers in advance of a public health emergency could allow CDC to supplement the supply produced by CDC and aid in the rapid manufacturing and deployment of test kits during a future public health emergency,” the report says. It underscored that “the agency did not have manufacturing contracts in place prior to the COVID-19 pandemic that could have supported the testing response.”

While CDC did meet with public health and private laboratory organizations beginning in 2018, the report notes that CDC “has not yet developed a plan for enhancing laboratory surge testing capacity that identifies objectives and outlines agency and stakeholder roles and responsibilities for achieving these objectives within defined time frames.”

The report lists numerous ways that CDC’s response contributed to slower testing early in the pandemic. These include guidelines for who should be tested that were too narrow; poor communication with public health laboratories; selecting a testing platform for the CDC SARS-CoV-2 test that only 12 public health laboratories had available; and the critical quality control failures that led to CDC releasing a flawed test.

CDC has begun to deal with problems, however, and the report details several initiatives. Among them, CDC will require all tests it develops to have clearly defined approval criteria to avoid another flawed test, and will require CDC labs to be accredited. The agency is also promising to boost collaboration with laboratory stakeholders, survey laboratories to improve understanding of surge capacity, and work with contractors on test kits rather than doing the work in-house.

Sen. Baldwin Introduces Disease X Act

Democratic Senator Tammy Baldwin of Wisconsin introduced legislation, the Disease X Act, that would fund countermeasures to combat future pandemics. The bill would provide $500 million per year for 4 years, starting in Fiscal Year 2022, for the Biomedical Advanced Research and Development Authority (BARDA) at the Department of Health and Human Services (HHS)
The bill envisions a Disease X Medical Countermeasures Program aimed at developing responses to unknown viral threats. BARDA would work with public health agencies to leverage expertise across the government to inform a strategic approach to medical countermeasures development.

The bill calls for HHS and the Department of Defense (DOD) investment strategies to work together, with HHS leading on products needed to protect the public and DOD taking the lead on products for military personnel.

“Infectious disease outbreaks now occur three times more often than they did 40 years ago. The next pandemic, driven by an unknown Disease X, will come,” said Senator Baldwin. “We should not be waiting for the next viral threat to emerge. We must invest in the development of novel antivirals, vaccines, and diagnostics for unknown threats now so that we are better prepared to control the spread than we were at the start of the COVID-19 pandemic.”