Georgia CTSA Leaders to Begin Phase 1 Validation for National COVID-19 Tests

Two of Georgia CTSA's leaders head up the NIBIB-funded Atlanta Center Microsystems Engineered Point of Care Technologies (ACME POCT) which has been selected by the NIH, along with their institutions - Emory, Georgia Tech, and Children’s Healthcare of Atlanta - to test and validate some of the most promising technologies for COVID-19 diagnostic testing.

Wilbur Lam, MD, PhD is the Principal Investigator of ACME POCT, clinical hematologist at Children’s, and Georgia Clinical & Translational Science Alliance (Georgia CTSA) Innovation Catalyst Program Director. Lam is working alongside Co-Principal Investigators Greg Martin, MD, MSc Professor of Medicine at Emory University, Chair of Critical Care for Grady Health System, and Georgia CTSA Clinical Research Centers (GCRCs) Program Director from 2015 through March 2020 and Oliver Brand, PhD, Professor at Georgia Tech and Executive Director of their Institute for Electronics and Nanotechnology.

On April 29, 2020, the NIH launched the Rapid Acceleration of Diagnostics (RADx) Initiative to fund projects that will speed the delivery of accurate, easy-to-use, scalable tests to all Americans. A National Call for Innovative Technologies was announced with rolling submissions. The proposals are initially assessed for technical, clinical, commercial and regulatory issues. Proposals that pass this assessment are then sent to ACME POCT for Phase 1 Validation and Risk Review which is set to begin.

Dr. Lam explains, “Anyone can apply. Committees form to review the proposals in a ‘Shark Tank’-like rapid selection process. These committees comprise many people with expertise in different areas. They spend about a week with the team, which could be a company, a startup, or a university investigator. Once the vetting committee makes a decision, they pitch it to the entire Point-of-Care Technologies Research Network and RADx leadership that includes ACME POCT. This steering committee includes me, Greg Martin and our colleagues at Georgia Tech. We vote whether the testing technology goes to Phase 1. Since we're part of the voting steering committee, we get a sense of what's coming around the corner for our Phase 1 Validation and Risk Review.”

Dr. Martin agrees, “There have been thousands of submissions, and we’re working through them in the ‘Shark Tank’ national committee selection process as fast as we can. Ones that have been approved will arrive very soon at the Phase 1 center here at Emory, Children’s, and Georgia Tech so we can conduct the Test Validation and Risk Review phase. Several more will be coming our way to determine which ones could be an effective diagnostic test to help the country.”

“The key to this is to deliver a highly accurate test as rapidly as possible. To do that, in Phase 1 we will confirm if the test performs at a high level of accuracy and reliability. We will also review the technical capabilities of the test – how rapidly can you conduct the test, how many reagents are required, and what type of technical skill is required to do the test - for simple, fast and efficient tests. Also, we want to confirm the test can be used in the designated environment and perform as expected, whether at home or in a hospital laboratory,” adds Martin. “To reduce the risk, the team wants to identify any problems and move things forward that will be successful in doing the screening and testing that we need. It’s a matter of doing this as rapidly as possible for the country. To quickly determine which tests will perform well in any setting is what we need to do.”

All of the test validation is being done at Emory, Children’s, and Georgia Tech. While some clinical testing will occur in Phase 1, market testing including usability and other factors in a real-world environment will occur in Phase 2 that is being coordinated by the University of Massachusetts Medical School.

“During Phase 2, we will be providing resources to do additional clinical testing in Atlanta including the Georgia CTSA Clinical Research Centers (GCRCs). We may be using the same infrastructure and GCRC resources that have recently been used for other studies to perform testing on people who may have been exposed to COVID-19 or may have infection,” says Martin. “It’s an honor to be designated the test center for these COVID-19 diagnostic tests. We’re working with an incredible team at Emory to deliver this as quickly as we can.”

Georgia CTSA’s multi-site Georgia CTSA Clinical Research Centers (GCRCs) is a multilayered, flexible, and geographically distributed network created to meet the needs of translational and clinical investigators from Emory University, MSM, UGA, Georgia Tech, and Children’s Healthcare of Atlanta (Children’s). The GCRCs offers dedicated space and a variety of resources ranging from core laboratory services to a bionutrition unit to support the research process at a subsidized cost. Clinical sites, including nursing services, are located at Emory University Hospital, Grady Memorial Hospital, UGA, MSM, Children’s, and Emory University Midtown.

The Georgia CTSA is a statewide partnership between Emory, MSM, Georgia Tech, and UGA and is one of over 60 in a national consortium striving to improve the way biomedical research is conducted across the country. The consortium, funded through the National Center for Advancing Translational Sciences (NCATS) and the National Institutes of Health's Clinical and Translational Science Awards, shares a common vision to translate laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train the next generation of clinical investigators. For more information, click here.