FDA and NCI to Review COVID-19 Antibody Tests Marketed Under FDA Guidance Permitting Sale Without FDA Authorization

 Sign up for our Coronavirus roundup email.
Visit our Coronavirus resource page.

In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, FDA noted it would not object to the distribution and use of serological (blood) tests for antibodies to COVID-19, without review by FDA, so long as the test had been validated, notice was given to FDA, and the test included certain cautionary statements about the lack of FDA review and need for more definitive testing.

This week, the National Cancer Institute confirmed reports that it is working with FDA to evaluate antibody tests marketed without FDA review pursuant to the FDA policy as part of FDA’s response to complaints concerning ineffective antibody testing. On April 17, 2020, Dr. Norman E. Sharpless, the Director of NCI, posted on the NCI website a summary of the Institute’s response to the COVID-19 pandemic. While emphasizing the Institute’s commitment to cancer treatments and research,[1] Dr. Sharpless noted NCI’s long history of research on viruses and viral treatments, many of which lead to cancer such as HIV and HPV, and the Institute’s extensive research infrastructure and clinical testing experience. As a result, the director stated that NCI’s capabilities “make our participation in the response to this pandemic a moral obligation.”  

According to Dr. Sharpless, the NCI Frederick National Laboratory for Cancer Research, the only federal funded research and development center dedicated to biomedical research, has been “temporarily repurposed” to work on serological testing for COVID-19. The laboratory, which normally focuses on blood testing for antibodies to HPV strains that cause cancer, will review COVID-19 antibody tests that are submitted to FDA for review as well as work with medical centers and other agencies on virus response. NCI also will be assisting with screening for potential chemical compounds to combat COVID-19 and collaborating on clinical studies for patients with both cancer and COVID-19.

As the COVID-19 crisis evolves, Seyfarth Shaw attorneys are closely monitoring actions taken by FDA and other government health and research organizations. We are available to protect your interests, help you mitigate risks and liabilities, and keep you informed regarding the latest implications related to the COVID-19 crisis. Visit our Resource Center for more information.

 

[1] As explained in the post, those with cancer are at higher risk of severe illness if infected with COVID-19, and the need to curtail viral spread has led to the postponement of certain treatments for cancer patients.