OPENING UP 

AMERICA AGAIN

TESTING OVERVIEW
THE CHALLENGE

This is the first time in history that the United States 

Government has ever scaled a testing regime to meet 

the massive needs of a nationwide pandemic
MOBILIZING ALL OF 

AMERICA’S RESOURCES

ROLES & RESPONSIBILITIES

FEDERAL 

GOVERNMENT

Enable Innovation, Scale Supplies, 

and Provide Strategic Guidance

STATE

GOVERNMENTS

Formulate and Implement

Testing Plans

PRIVATE 

SECTOR

Develop and Produce Supplies and 

Services to Meet Needs of States
1. Build the foundation for diagnostic testing

2. Mobilize the private sector to develop tests

3. Issue Emergency Use Authorizations (EUAs) for tests

4. Galvanize commercial and research laboratories and professional associations to 

ramp up testing capacity

5. Facilitate State efforts to access and utilize all available testing capacity

6. Identify and expand public and private-sector testing infrastructure

7. Strengthen testing supply chain

STAGE 1: LAUNCH

STAGE 2: SCALE

STAGE 3: SUPPORT OPENING UP AGAIN

8. Coordinate with governors to support testing plans and rapid response programs

8-PART 

PLAN 
OPENING UP AMERICA AGAIN 

BY ACCELERATING TESTING

The Federal Government is helping 

States ramp up testing capacity as 

outlined in the President’s Opening Up 

America Again Guidelines
Identify any newly emergent cases or clusters of COVID-19

among symptomatic and asymptomatic individuals.

TIMELY MONITORING SYSTEMS

Ensure capability to overcome barriers to efficient testing 

and inform clinical care and public health decision-making.

ROBUST DIAGNOSTIC TESTING PLANS

Develop and implement effective isolation and contact 

tracing strategies for newly diagnosed COVID-19 cases.

RAPID RESPONSE PROGRAMS

CORE ELEMENTS

OF TESTING PLANS
STAGE 1: LAUNCH

1. Build the foundation for diagnostic testing

The Centers for Disease Control and Prevention (CDC) has determined the molecular composition of the virus and 

published this information in a public database for researchers to use to develop diagnostic tests.

KEY DATES

January 10: CDC begins developing a test for public health laboratories to use to detect COVID-19.

January 18: CDC begins to test specimens for COVID-19.

January 20: CDC confirms the first case of COVID-19 in the United States.

January 24: CDC publishes the genetic sequence of the first domestic case of the virus on NCBI/GenBank.
STAGE 1: LAUNCH

2. Mobilize the private sector to develop tests

The Food and Drug Administration (FDA) has worked with more than 380 test developers who have indicated their intent 

to submit requests for EUAs for tests that detect the virus or antibodies to the virus.

The FDA has helped streamline the review process, including by: 

ü Publishing immediately-in-effect guidance for policies specific to this public health emergency

ü Providing templates to facilitate EUA submission

ü Holding weekly virtual town halls to answer questions from developers

KEY DATES

January 21: The Biomedical Advanced Research and Development Authority (BARDA) convenes leading diagnostics companies to 

encourage development of COVID-19 tests.

February 15: BARDA announces funding opportunities for developing COVID-19 diagnostic tests.

February 21: The National Institutes of Health (NIH) provides COVID-19 RNA to diagnostics companies to expedite private-sector test 

development.

February 29: FDA permits immediate use of laboratory-validated tests, rapidly expanding testing capacity.

March 4: The Vice President and senior Administration officials convene meeting with leading diagnostics companies.

March 7: FDA updates EUA template for laboratories.

March 12: FDA updates EUA template for manufacturers.
STAGE 1: LAUNCH

3. Issue EUAs for tests

FDA has facilitated scaling of testing capacity to address the public health emergency.

KEY DATES

March 13: FDA issues an EUA for Roche’s 

cobas COVID-19 test within 24 hours of 

receiving the application.

March 18: FDA issues the first emergency 

use authorization for a point-of-care COVID19 diagnostic test (Abbott).

April 21: FDA authorizes the first COVID-19 

diagnostic test with a home collection 

option (LabCorp). 

As of April 27: FDA has issued 70 EUAs (62 

for molecular tests and 8 for serological 

tests).

17

3 2

13

1

20

70

2009 H1N1 2013 H7N9

Avian

Influenza

2013 MERS

Coronavirus

2014 Ebola

Virus

2015

Enterovirus

D68

2016 Zika COVID-19

Testing EUAs for Viral Outbreaks

Source: FDA
STAGE 1: LAUNCH

4. Galvanize commercial and research laboratories and professional associations to ramp up testing capacity

The Administration has encouraged diagnostic test manufacturers, commercial laboratories, and professional societies to 

expand capacity for existing nucleic acid testing platforms. 

KEY DATES

March to Early April: The Administration, in 

consultation with large diagnostic test 

manufacturers, identifies locations of 

laboratory-based machines in the country.

April 17: The Administration convenes 

meeting with the American Society for 

Microbiology to facilitate enhanced utilization 

of existing nationwide laboratory capacity.

Ongoing: The Administration is providing 

technical assistance to all States and 

territories as they maximize utilization of 

existing laboratory capacity.

Source: The COVID Tracking Project

0

100,000

200,000

300,000

3/15/20 3/25/20 4/4/20 4/14/20 4/24/20

United States Daily Tests
STAGE 1: LAUNCH

5. Facilitate State efforts to access and utilize all available testing capacity

The Administration has reached out to governors to help them better utilize the testing capacity within their States.

KEY DATES

January to Present: The President, Vice President, and senior Administration officials hold more than a dozen governors-only briefings, 

many of which have focused on joint Federal-State efforts to expand testing throughout the country. In addition, the White House 

organizes numerous calls to enhance testing coordination efforts at the State, local, and tribal levels. 

April 21: The White House organizes a briefing call between key senior Administration officials and large diagnostic test manufacturers

(Abbott, Roche, and Thermo Fischer Scientific) with governors’ senior staff, state health officers, state lab officials, state 

epidemiologists, and state emergency managers on near-term COVID-19 testing priorities.

By April 25: The Administration finalizes a database of nationwide laboratory capacity and publishes maps displaying their locations. 

The Administration also conducts at least one individual working session with every State to provide advice about testing capacity, 

including the location of specific testing platforms.
6. Identify and expand public and private-sector testing infrastructure

The Administration has supported and expanded the public and private-sector testing infrastructure to accelerate 

testing in communities across the country. 

STAGE 2: SCALE

KEY DATES

February 29: FDA authorizes New York state laboratory diagnostic test (first non-CDC COVID-19 diagnostic test).

Early March to Present: Millions of new tests, including Point-of-Care (POC) tests, are surged to hospitals and other testing locations. 

March 19: CVS launches the first retail-based testing site in Massachusetts.

As of April 25: United States retailers are operating 80 federally supported testing sites in 24 States.

By May 1: United States retailers will be operating a total of 100 federally supported testing sites in 33 States.
STAGE 2: SCALE

7. Strengthen testing supply chain

The Administration has increased the availability of testing and laboratory supplies by working directly with 

manufacturers and distributors to increase production capacity through direct procurement, application of Titles I and 

III of the Defense Production Act, formation of public-private partnerships, and improved allocation criteria that help 

ensure supplies reach the locations where they are needed the most.

KEY ACTIONS (Ongoing)

ü More than 5.2 million tests have been performed in the United States.

ü Private laboratory testing supply companies ramp up manufacturing capacity of extraction kits, PCR kits, and reagents.

ü The Federal Government partners with multiple companies to expand domestic production of critical specimen collection supplies 

such as swabs and collection tubes.

ü The Federal Government has directly procured 6.7 million swabs, 3.3 million transport media, 15 million lancets, and 15 million 

alcohol pads.

ü Project AirBridge has completed 86 flights, with 26 more scheduled for the near future, which have transported 71.3 million masks, 

8.5 million gowns, and 724.8 million gloves to the United States from countries around the world. In total, the Federal Government 

has facilitated the nationwide delivery of 175.2 million masks, 14.7 million gowns, and 793.8 million gloves.
TOTAL TESTS CONDUCTED 

BY COUNTRY

United States

Canada

Italy

Japan

South Korea

United Kingdom

0

1

2

3

4

5

3/15/20 3/22/20 3/29/20 4/5/20 4/12/20 4/19/20 4/26/20

Source: University of Oxford, Our World in Data. CUMULATIVE TESTS (Millions)

USA

ITALY

CANADA

SOUTH KOREA

UNITED KINGDOM

JAPAN

The United States has 

conducted more tests than 

Australia, Austria, Canada, 

France, India, Italy, Japan, 

Singapore, Sweden, South 

Korea, and the United 

Kingdom combined.
COVID-19 

LABORATORY 

TESTING 

CAPACITY

Source: Based on data provided to the Department of Health and Human Services (HHS) from select diagnostics companies 
MONTHLY 

TESTING 

CAPACITY PER 

1,000 PEOPLE

Source: Based on data provided to HHS from select diagnostics companies 

COVID-19 Testing Capacity per 1,000 People by State, April 26, 2020

300 to 400

400 to 500

500 to 600

600 to 700

700 to 800

800 to 900

Over 900
STAGE 3: SUPPORT OPENING UP AGAIN

8. Coordinate with governors to support testing plans and rapid response programs

The Administration has provided a Blueprint that describes roles and responsibilities, as well as principles and 

elements of the robust testing plans and rapid response programs called for in the President’s Guidelines. 

CONTINUED FEDERAL GOVERNMENT SUPPORT WILL INCLUDE:

• Providing expedited regulatory approvals for tests and testing equipment.

• Publishing and updating procedural guidance for administering diagnostic tests (i.e., prioritization algorithms and protocols). 

• In partnership with the private sector, accelerating research and development of innovative diagnostic tests, such as:

o Highly specific and sensitive antibody tests.

o An antigen test to detect active infection quickly and accurately. 

o Advancing simplified, rapid POC nucleic acid testing.

o Genomic sequencing technology.

• Identifying and sharing best practices and providing technical assistance to State, local, and tribal governments to improve their 

testing, surveillance, and contact tracing programs.

• Acting as supplier of last resort.
PATH FORWARD

The Federal Government will continue to support State 

efforts to accelerate testing plans and programs that 

help enable America to Open Up Again