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President Biden Announces Plan to Expand SARS-CoV-2 Testing, Increase Capacity

NEW YORK – On his first full day in office Thursday, President Joseph Biden unveiled his strategy to address the COVID-19 pandemic, increasing testing availability and enhancing laboratory capacity to conduct testing.

In his National Strategy for the COVID-19 Response and Pandemic Preparedness, Biden emphasized his goal to scale and expand testing, creating a national pandemic testing board to "oversee implementation of a clear, unified approach to testing." The federal interagency board will be chaired by the COVID-19 Response Testing Coordinator. In a briefing to discuss the strategy, Biden said the board would "ensure we get testing to where it is needed and where it is needed most," such as schools and businesses.

Through an executive order creating the board, the president will also direct agencies to provide free testing for people without health insurance and clarify payors' obligations to cover testing. The American Clinical Laboratory Association released a statement commending the president for his plan. "Despite the widespread agreement that testing is a critical tool in our efforts to address the pandemic, in June, guidance from the U.S. Departments of Health and Human Services, Labor, and Treasury curtailed clear coverage mandates passed by Congress that required comprehensive health plans to cover COVID-19 testing without cost sharing or prior authorization," ACLA President Julie Khani said. "This created growing coverage gaps for many Americans." 

Under the plan, the federal government will expand the rapid testing supply, double test supplies, and increase testing capacity. In addition, the administration will increase antigen and molecular testing manufacturing in the US, fill testing supply shortfalls, enhance laboratory capacity to conduct testing, and expand surveillance for hotspots and variants of the virus. The government will invest in laboratory capacity, including "long-term regional testing capacity to improve testing timelines," and will promote research and innovation in testing, including at-home tests and instant tests.

The president will invoke the Defense Product Act (DPA) to fill supply chain issues for testing supplies and personal protective equipment (PPE), such as PCR sample collection swabs, test reagents, pipette tips, PCR instruments, high-absorbency foam swabs, nitrocellulose material for rapid antigen tests, and rapid test kits. Biden in his briefing called the scaling up of manufacturing capabilities a "full-scale wartime effort." The government will also "make a commitment toward a five-year investment in onshore manufacturing of test kits and related supplies for COVID-19 and emerging biological threats," the plan said.

The DPA authority will also be used to offer loans to manufacturers to increase their production capacity for COVID-19 tests and decrease competition for supplies, the plan said. It will also replenish depleted testing and PPE supplies in high-risk areas and populations, making those supplies more affordable and available.

Patrick Godbey, president of the College of American Pathologists, said after President Biden's announcement, "While 2 million tests are being provided every day, surveys of laboratory directors have consistently reported that more testing could be performed but their labs are constrained by several limitations. Specifically, laboratory directors have cited problems acquiring testing supplies. Having enough test kits, plastic pipette tips, and specimen acquisition swabs, as well as transport media, are the greatest barriers to increased COVID-19 testing." 

The federal government will also support school screening testing programs to help schools reopen, fund rapid test acquisition and distribution "for priority populations," spur development and manufacturing of at-home tests, and "stand up a dedicated [US Centers for Disease Control and Prevention] Testing Support Team." These teams will help schools develop plans for regular testing, assist with getting consent for testing, and help with sample collection and contact tracing.

Under-resourced colleges, such as community colleges and historically black colleges and universities, will have access to funds for COVID-19 testing, as well, the plan noted.

Testing protocols will be provided to guide the use of testing in congregate settings and other critical areas, as well as among asymptomatic individuals, and technical assistance will be available to support more widespread adoption of testing.

The CDC will offer guidance on a variety of "key issues," such as testing, contact tracing, and reopening schools and businesses. The plan also emphasized the increased use of data to guide the public health response, including data to track access to testing. The federal government will implement a set of common metrics for states to report on to track testing, contact tracing, preparedness and treatment, and hospital capacity to determine where additional resources should be directed. The plan also said the government will focus on areas with outdated data systems, particularly those that have trouble connecting testing laboratories and public health agencies.

Support will also be provided to states to increase public access to COVID-19 testing, including community-based collection locations to options for at-home testing.

Last week, Biden unveiled an economic plan that included the allotment of $50 billion to expand testing for COVID-19.