In its urgent efforts to confront the novel coronavirus, the U.S. Food and Drug Administration (FDA) has tapped 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.
FNL has an adaptive cancer research infrastructure and longstanding expertise in serology and immunology, making it an excellent scientific partner for the effort.
Heading up the new mission at the FNL is Ligia Pinto, Ph.D., who directs the Vaccine, Immunity and Cancer Program, which includes the HPV Immunology Laboratory and the HPV Serology Laboratory.
FNL is sponsored by the National Cancer Institute, a part of the National Institutes of Health, and is operated by Leidos Biomedical Research Inc. 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.
A long research history
Although the serology lab has been in operation only since 2017, Dr. Pinto and her staff have a long history of research excellence for the National Institutes of Health that make her facility well-placed for key contributions to research against COVID-19.
After completing her doctorate in immunology from the University of Lisbon (while working in the Experimental Immunology Branch of NIH) in 1995, Dr. Pinto remained at NIH, investigating immunological alterations induced by the human immunodeficiency virus, or HIV, which causes AIDS.
In 2001, Dr. Pinto joined FNL, to establish the HPV Immunology Laboratory. Some strains of HPV, the human papillomavirus, can cause several cancers, including cervical cancer. Research from the HPV Immunology Laboratory has played a critical role in the understanding of immune responses induced by licensed HPV vaccines during clinical trials. The lab has provided key 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.
The HPV Serology Laboratory is working to confront a lack of standardized assays, procedures, and reagents accessible to the scientific community for the comparison of different studies evaluating immune responses induced by HPV vaccines.
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.
Dr. Pinto and her team at FNL are contributing to the broader Health and Human Services response by 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 antbodies 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 NCI’s 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 agency updated its earlier policy guidance on antibody tests for commercial test manufacturers related to emergency use authorizations and providing specific clinical performance expectations for these tests. Dr. Pinto and her team at the FNL do not make recommendations to the FDA regarding regulatory actions.
For information on tests and other COVID-19 serology testing status, email FDA or call 301-348-1956.Tagged: