Testing & Diagnostics

Public Health Supply Chain and Industrial Base 
One-Year Report

The supply chain for testing, including diagnostics, is complex and global, requiring materials from both domestic and foreign sources, thereby risking possible disruption. Once shipped to the United States, raw materials are utilized to generate test kits and other reagents for use in both closed and open diagnostic systems. Early in the pandemic, shortages of a few common raw materials (e.g., swabs, test reagents) gave way to more widespread shortages of a variety of testing components and consumables (e.g., pipette tips, antigen test strip), secondary to resin and nitrocellulose shortages. Many companies manufacture testing instruments and consumables internationally and ship them to the United States for assembly and kitting. Shipping logistics and skilled labor challenges are exacerbating supply chain issues for testing and diagnostic materials.

When the pandemic first began, no tests for COVID-19 existed. CDC and the private sector worked quickly to meet rapidly growing demand, and as of January 2022, there are two categories of tests—diagnostic and antibody tests—produced by several different manufacturers. FDA has authorized the use of a number of tests under EUA, including individual EUAs for molecular, antigen, antibody and other adaptive immune response tests for COVID-19.xvi Different tests may be conducted in a laboratory, healthcare setting, or completed at home and may vary in accuracy and speed. As the pandemic has evolved, the demand for tests has also changed. Since the beginning of the COVID-19 pandemic, the testing and diagnostic supply chain has been stressed and some of these challenges remain with acquiring, producing, and distributing almost all components of the testing supply chain.^xvii

Current Overview

Testing supply chain limitations have largely arisen from molecular tests carried out in central laboratories. These tests are highly complex and require specialized equipment. They also involve numerous steps, including sample collection, storage, and transport; sample preparation, including extraction of nucleic acid; and sample analysis and processing. The number of end-to-end steps and actions involved with these tests illustrates the complexities and challenges associated with the testing supply chain.

In vitro diagnostic devices (IVDs), for both COVID-19 and other diseases, are made by a variety of test developers, including conventional manufacturers and laboratories. Manufacturers are in a variety of locations, including in the United States, Europe, China, India, and other countries. IVDs cover a wide range of devices spanning different diseases, conditions, and patient populations.

Despite the current challenges and limitations, HHS has achieved notable successes. As of January 2022, FDA has authorized 423 tests and sample collection devices for SARS-CoV-2 under EUA, including

• 291 molecular tests and sample collection devices;
• 87 antibody and other immune response tests;
• 45 antigen tests;
• 1 molecular and 3 antigen prescription at-home tests;
• 69 molecular and 1 antibody authorization that can be used with home-collected samples;
• 14 antigen and 3 molecular over-the-counter at-home tests;
• 25 antigen tests and 9 molecular tests for serial screening programs.

FDA has also authorized 783 revisions to SARS-CoV-2-related EUA authorizations.

Current Actions to Address Supply Chain Vulnerabilities

To stabilize test production rates and related supplies and to reduce vulnerabilities associated with import delays, increased costs, and offshore sourcing, the U.S. Government has

• funded capital purchases to build, expand, and improve production of test kits and supplies, such as swabs and reagents;¹⁷
  
• improved coordination and information sharing with test suppliers to help sync production capacity with demands;
• funded test manufacturers and their supply chain to onshore production of tests, test kit components, and reagents from non-domestic manufacturing plants.

HHS is working to expand U.S.-based manufacturing of point-of-care molecular tests to avoid importing the supplies and materials used in the tests. This work supports jobs for American workers, boosts the U.S. economy, and increases access to point-of-care molecular tests.

Modeling Testing Demand: As of March 2021, the Pandemic Testing Board’s Work Group on Supply and Distribution has been defining principles and strategies to achieve sufficient testing and upstream supply production. Since then, their demand model has been enhanced to explore simultaneous scenarios, such as high and low vaccination rates, high and low screening, high and low transmissibility, and high and low vaccine escape. Over-the-counter testing supply and demand are explored separately from laboratory testing supply and demand.

Increasing Testing Capability: Since June 2020, the U.S. Government has invested in increasing the production of COVID-19 tests from 40 million per month to 257 million tests per month in September 2021 to over 400 million per month in December 2021. Demand for COVID-19 tests continued to rise in the last quarter of 2021 coinciding with the Omicron surge. U.S. Government investments in rapid antigen test production have incentivized the market to produce more tests. With COVID-19 case surges and testing mandates, HHS investments are addressing the demand for lab-based tests, point-of-care tests, and at-home tests.

Expanding At-Home Testing: Beginning in February 2021, the U.S. Government has used the DPA, industrial mobilization, and advance purchase commitments to ramp up supply of testing, including at-home, rapid tests. Advance purchase commitments allowed domestic testing manufacturers to increase production, add factory lines, increase staffing, and move up manufacturing timelines. As a result, the United States went from 24 million at-home, rapid tests on the market in August 2021, to 46 million in October, to 100 million in November, to over 300 million in December, to 375 million in January 2022. U.S. Government investments in at-home tests guarantee a specific number of tests will be bought and paid for, which provides stability to the supply chain.

In December 2021, the U.S. Government announced plans to expand free at-home testing by purchasing one billion tests to be distributed to the U.S. population. In January 2022, the U.S. Government made 500 million at-home tests available for order online at no cost to the customer. It also announced employment-based group health plans and private health insurance companies will be required to expand coverage of at-home COVID-19 tests without cost sharing. In February 2022, the Administration announced Medicare will cover over-the-counter tests. The U.S. Government also plans to distribute 50 million at-home tests through neighborhood sites, community providers, and rural clinics. These actions provide much needed assistance to those who lack the financial means to pay for testing or for whom accessing testing sites is difficult. The United States is on track to quadruple the supply of rapid at-home tests as compared to Summer 2021 levels.^xviii

Accelerating Diagnostics: The National Institutes of Health (NIH), in conjunction with other U.S. Government agencies, established the Rapid Acceleration of Diagnostics (RADx^®)/Advanced Technology Platforms. The purpose of this program is to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing.^xix The program funds the development and maturity of COVID-19 diagnostic technology up to the point when it is ready to be accelerated to market and supports the validation and scale-up of manufacturing capacity.

Planned Actions to Address Supply Chain Vulnerabilities

The United States needs continued innovation, research, and development in testing and diagnostics. This includes advances in at-home testing and data collection and analysis, which could be leveraged now and during future large-scale infectious disease outbreaks.^xx There is a need to encourage and enable greater innovation to improve testing technology and lower the cost of testing, so tests will be available to all who want them.

Invest in Testing Kit Research and Development: Investing in test kit research and development may increase test availability. Lowering the cost of the starting components through development of new manufacturing processes could help reduce test kit costs. Research into improving the shelf-life of tests and their reagents could lead to a shelf-life extension, allowing unused tests and materials to remain on shelves longer.

Increase Test Component Interchangeability: The interchangeability of non-patented test components would assure vendors are producing interchangeable supplies, increase volume of common components, and reduce spot shortages. Improving human capital through training and education, while a difficult challenge, could improve test production, and warrants further investigation.

Ensure COVID-19 Testing Capacity: The U.S. Government will continue to invest to ensure sufficient COVID-19 testing capacity. It will accomplish this through stockpiling tests and testing supplies while simultaneously working closely with the industrial supply chain. HHS will prioritize warm-base production capacity that will allow test, component, and reagent suppliers to quickly scale up production during surges in demand. The U.S. Government is also planning investments to help reduce the costs of tests, broaden detection capabilities to include multiple viruses and pathogens, increase production, and make tests more widely available. The U.S. Government plans to invest further in training and human capital.

Fortifying a robust testing and diagnostics supply chain will ensure that tests and diagnostics are ready to be developed, deployed, and analyzed during future public health emergencies.