NCI and FNL lead federal effort to evaluate antibody tests for COVID-19 virus
As part of a collaboration with the Food and Drug Administration (FDA) and several other government agencies and academic medical centers,the National Cancer Institute (NCI) is evaluating commercially available antibody tests for SARS-CoV-2, the novel coronavirus that causes COVID-19.
Specifically, the FDA asked the Frederick National Laboratory for Cancer Research (FNL) to scientifically inform its decision-making on potential approval of blood tests for the presence of antibodies to SARS-CoV-2.
The Intellectual Property and Strategic Agreements Office (IP/SA) at FNL quickly responded in support of this effort. Within 24 hours of determining the need for an agreement, the office developed a unique, specialized testing agreement to allow FNL to receive the SARS-CoV-2 antibody tests. The testing agreement is being provided to more than 120 manufacturers and distributors who could choose to participate in the FDA’s call for evaluation of SARS-CoV-2 antibody tests.
In creating the unique agreement, Dr. Claudia Haywood, director of the FNL (IP/SA), together with NCI’s Technology Transfer Center, focused on developing a simple and easy to comprehend technology transfer mechanism that could be quickly deployed. The (IP/SA) also facilitated Material Transfer Agreements allowing the FNL to receive COVID-19 patient samples utilized as a part of the testing process.
“When responsiveness is of the utmost importance, it’s critical to look at the tools that you have in hand and adapt them to meet the immediate need,” Dr. Haywood said. “We had to quickly understand our client’s goal (the FDA) and the risks associated with the project, and then develop something from within our toolkit that we could turn around quickly. Especially in times of crisis, you have to be creative, transparent, and ensure that all parties involved understand the goals and objectives.”
As of June 25 and since making the testing agreement available, the (IP/SA) has executed 162 agreements with test manufacturers and distributors; they are receiving more agreements each day.
A long research history
FNL is sponsored by the NCI, a part of the National Institutes of Health, and is operated by Leidos Biomedical Research, Inc., which is headquartered in Frederick, Maryland. As the only Federally Funded Research and Development Center solely dedicated to biomedical research, the FNL gives NCI flexibility to rapidly allocate expertise and resources to address urgent public health priorities.
Because of its robust research infrastructure, including expertise in developing human papillomavirus (HPV) vaccines and management of an advanced serology laboratory, the FNL has been tapped to provide independent testing and validation of SARS-CoV-2 antibody tests.
FNL has an adaptive cancer research infrastructure and longstanding expertise in serology. Heading up the new mission at the FNL is Ligia Pinto, PhD, who directs the Vaccine, Immunity and Cancer Program, which includes the HPV Immunology Laboratory and the HPV Serology Laboratory. Although the serology lab has been in operation since 2017, Pinto and her staff have a long history with NIH that makes her facility well-placed for key contributions to COVID-19 research.
After completing her doctorate in immunology from the University of Lisbon in 1995, while working in the Experimental Immunology Branch of NIH, Pinto continued her career at NIH, investigating immunological alterations induced by the human immunodeficiency virus, or HIV, which causes AIDS. In 2001, Pinto joined FNL, to establish the HPV Immunology Laboratory.
Research conducted by Pinto and her colleagues at the HPV Immunology Laboratory has played a critical role in the understanding of immune responses induced by HPV vaccines during clinical trials. The lab has provided evidence, now being tested in a randomized clinical trial, that a single dose of the HPV vaccine could provide stable immunity against two of the most common strains of HPV for more than a decade following vaccination. When first approved, the HPV vaccine required three doses; today it is, for young adolescents, down to two. Fewer doses tend to lead to increased vaccination rates. Because of its relevant research history and NCI’s ability to rapidly allocate expertise and resources to address urgent public health priorities through the FNL, the serology lab is uniquely suited to the task to evaluate serology tests. Today, the HPV Serology Laboratory is being repurposed to evaluate serology tests during the COVID-19 pandemic.
Current pressing needs
Antibody tests—also known as serology tests—are blood-based tests designed to detect serum antibodies (proteins made by the immune system), to determine if a person’s immune system has responded to a particular foreign substance or infection, for instance with a virus such as the novel coronavirus. Importantly, antibody tests do not detect the virus in someone’s blood, but they can help determine whether a person’s immune system has responded to the virus. Current research is seeking to determine whether the antibodies in an individual are associated with protection from future infection.
“With support from Congress, NCI is working with the FDA and other government agencies to rapidly and rigorously characterize the performance of serology assays,” said Douglas Lowy, MD, NCI’s principal deputy director and a leading expert on HPV. The results of serology tests, along with other relevant information, such as a person’s clinical history or other diagnostic test results, “can help determine who in the community has had a prior COVID-19 infection,” Lowy said.
SARS-CoV-2 serology
Pinto and her team at FNL are evaluating serology tests for the novel coronavirus, SARS-CoV-2, and reporting performance data on serology tests to the FDA. The team is evaluating tests for two types of antibodies (IgG and IgM) against a well-characterized panel of 110 samples, made up of 30 positive and 80 negative samples. That panel of samples was developed with the help of FDA, the Centers for Disease Control and Prevention, the National Institute of Allergy and Infectious Diseases, the Biomedical Advanced Research and Development Authority within the HHS Office of the Assistant Secretary for Preparedness and Response, and academic collaborators. Each sample in the panel was tested for the presence of SARS-CoV-2 antibodies by at least two separate labs.
On April 28, 2020, the FDA announced an “umbrella” Emergency Use Authorization process for SARS-CoV-2 antibody tests (Lateral flow or Enzyme-linked immunosorbent assay, or ELISA, tests) that have been evaluated in an independent validation study performed at the FNL. For this process, manufacturers provide sample kits to FNL, which in turn provides performance data to FDA for regulatory decision-making. On May 4, the FDA updated its earlier policy guidance on antibody tests for commercial test manufacturers related to emergency use authorizations (EUAs) and providing specific clinical performance expectations for these tests. (Pinto and her team at the FNL do not make recommendations to the FDA regarding regulatory actions.) By June 4, the FDA issued EUAs for additional tests. In addition, the FDA also made some NCI evaluation results publicly available to show the rationale for granting EUAs.
For information on tests and other COVID-19 serology testing status, email FDA or call 301-348-1956.