Special Report: The 5 Things Labs Need to Know About the Biden COVID-19 Testing Plan

Testing labs on the front lines of the COVID-19 battlefield are getting federal reinforcements. And it’s not just money. The new administration is taking an entirely new line of attack that differs from the approach of its predecessor in almost every conceivable way. Perhaps the most stark contrast is with regard to urgency, with the new president unveiling his COVID-19 testing strategy on his very first day in office. Here’s a quick overview of the five key elements of the Biden plan, aka, National Strategy for COVID-19 Response and Pandemic Preparedness.

1. Provide More Money

Let’s start with money. The administration’s proposed $1.9 trillion American Rescue Plan includes $50 billion to expand COVID-19 testing by providing funding to purchase rapid tests, expand lab capacity and support regular testing efforts of schools and local governments.

2. Ensure Free COVID-19 Testing

The new administration is continuing the free testing policy of its predecessor but in a much more direct and hands-on fashion. A new Executive Order establishes the COVID-19 Pandemic Testing Board to oversee implementation of a clear, unified approach to testing and directs agencies to facilitate testing free of charge for those who lack health insurance and to clarify insurers’ obligation to cover testing. The federal government will also provide testing protocols to inform the use of testing in congregate settings, schools, and other critical areas and among asymptomatic individuals. Further, technical assistance will support more widespread adoption of testing to improve timely diagnosis and public confidence in the safety of settings like schools.

3. Step Up Production of COVID-19 Tests

On February 17, the White House COVID-19 Response Team announced that the administration will provide $1.6 billion to expand and improve COVID-19 testing and genomic sequencing. The U.S. Centers for Disease Control and Prevention (CDC) will invest almost $200 million to finance a threefold expansion of sequencing for the virus and its variants from 7,000 to about 25,000 samples per week. It’s not as much money as some experts believe is necessary to achieve maximum COVID-19 sequencing capacity, but it’s a nice start.

The sequencing initiative comes about two weeks after the Response Team announced that the administration is finalizing contracts with six undisclosed companies to increase domestic testing capability for at-home SARS-CoV-2 tests, which would lead to 61 million point-of-care or at-home tests by the end of the summer.

4. Step Up Production of Testing Supplies

Another cornerstone of the Biden Plan is to promote production of vaccines, tests, PPE, reagents and other critical testing materials that have been in short supply. As with free testing, the most dramatic change is not in the policy but its execution, specifically the administration’s willingness to invoke federal government control over industry under a law called the Defense Production Act (DPA). A new Executive Order directs federal agencies to exercise the DPA and other applicable legal powers to get industry to accelerate the manufacturing, delivery and distribution of 12 categories of critical supplies, including taking action to increase the availability of supplies including:

• N95 masks, isolation gowns, nitrile gloves and other PPE;
• PCR sample collection swabs;
• Test reagents;
• Pipette tips;
• Lab analysis machines for PCR tests;
• High-absorbency foam swabs and nitrocellulose material for rapid antigen tests;
• Rapid test kits; 
• Low dead-space needles and syringes; and
• Necessary equipment and material to accelerate the manufacture, delivery, and administration of COVID-19 vaccine.

Meanwhile, the new Pandemic Testing Board is establishing regional coordinating centers to identify lab testing capacity and match it to specific areas of need. The coordinating centers will partner with labs, including academic and commercial labs, to collect specimens, perform tests, and report results.

5. Fix the COVID-19 Testing Supplies Chain

In addition to hitting the gas on immediate production, the Biden plan includes measures to fix the structural and systemic supplies and logistical bottlenecks that have bedeviled COVID-19 testing efforts during all phases of the public health emergency. The $1.9 trillion rescue plan provides $30 billion to the Disaster Relief Fund to help ramp up production of supplies including items like vials, reagents, and protective gear that are essential to collecting and running clinical samples. In addition, key federal agencies have been ordered to collaborate and work alongside industry to support projects to expand and improve production and distribution of PPE and testing supplies.

Takeaway

The point of this overview is not that the Biden plan is superior to the Trump COVID-19 testing strategy but that it’s vastly different. An administration philosophically opposed to government regulation has been succeeded by a regime prepared to use any and every source of legal authority at its disposal to tackle the crisis. It’s the same approach that Lincoln and Franklin D. Roosevelt followed to confront the national emergencies they faced. Only time will tell whether it works for COVID-19.

**************

This article originally appeared in G2 Intelligence, National Intelligence Report, March 2021.