publication date: May. 8, 2020

NCI receives $306 million in new money for COVID-19 serology test research;

Details to follow at BSA meeting May 12

By Paul Goldberg

This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.

NCI has received additional $306 million under a COVID-19 aid package “to develop, validate, improve, and implement serological testing and associated technologies applicable to COVID-19.”

The measure was signed by President Donald Trump April 24.

“The emergency appropriation will allow NCI to continue to work with the Department of Health and Human Services, the National Institute of Allergy and Infectious Diseases, and other government agencies to apply our expertise and advanced research capabilities to respond to this pandemic, including efforts to rigorously characterize the performance of serology assays,” NCI said in a statement in response to questions from The Cancer Letter.

“Additionally, NCI will leverage the experience, expertise, and breadth of the extramural research community to grow the national serologic testing capacity, develop novel assays and gain a deeper understanding of the viral infection and immune response to coronavirus, particularly among cancer patients and other vulnerable populations,” the statement reads. “We plan to outline funding opportunities at an upcoming meeting of the Board of Scientific Advisors May 12.”

Last month, at an emergency virtual meeting of the NCI Board of Scientific Advisors and the National Cancer Advisory Board, Douglas Lowy, NCI principal deputy director, described the institute’s initiatives focused on SARS-CoV-2 (The Cancer Letter, April 17, 2020).

Lowy listed three projects underway at the NCI’s Frederick National Laboratory for Cancer Research:

  • Testing and validating serologic assays for SARS-CoV-2 in the Serology laboratory of the Vaccine, Immunity, and Cancer Program,

  • Identifying genetic determinants of SARS-CoV-2 susceptibility and outcomes at the Cancer Genomics Research Laboratory, and

  • High-throughput screening for small molecule inhibitors of SARS-CoV-2 proteins, with technology developed by the RAS Initiative.

On May 6, FDA released the first test report and published data from an independent validation study performed to assess the sensitivity and specificity of 12 serology tests.

The assessment was performed at FNLCR.

According fo FDA, the results come from a collaboration between the regulatory agency, NIH, Centers for Disease Control and Prevention, and Biomedical Advanced Research and Development Authority to evaluate certain serological tests.

“While the [Emergency Use Authorization] request was not granted solely based on the validation data, the data were leveraged to inform FDA’s decision-making,” FDA said. “The NCI FNLCR test report provides new details on the testing that is being performed by NCI. Essential samples and materials used in the evaluation were provided by the NIH National Institute of Allergy and Infectious Diseases, the Mount Sinai Health System, the Icahn School of Medicine at Mount Sinai, including members of the Departments of Microbiology and Pathology, and the Vitalant Research Institute.”

Altogether, 12 tests have been given EUAs, the agency said in a recent blog post describing evolution of it criteria for authorization of serology tests for SARS-CoV-2.

The $306 million in new funds given to NCI are larger initiative to fund development of diagnostic, serologic, antigen, and other tests by federal agencies:

  • That of the amount appropriated under this paragraph in this Act, not less than $306,000,000 shall be transferred to the ‘‘National Institutes of Health—National Cancer Institute’’ to develop, validate, improve, and implement serological testing and associated technologies for the purposes specified under this paragraph in this Act.

  • That of the amount appropriated under this paragraph in this Act, not less than $500,000,000 shall be transferred to the ‘‘National Institutes of Health—National Institute of Biomedical Imaging and Bioengineering’’ to accelerate research, development, and implementation of point of care and other rapid testing related to coronavirus.

  • That of the amount appropriated under this paragraph in this Act, not less than $1,000,000,000 shall be transferred to the ‘‘National Institutes of Health—Office of the Director’’ to develop, validate, improve, and implement testing and associated technologies; to accelerate research, development, and implementation of point of care and other rapid testing; and for partnerships with governmental and non-governmental entities to research, develop, and implement the activities outlined in this proviso.

  • That of the amount appropriated under this paragraph in this Act, not less than $1,000,000,000 shall be available to the Biomedical Advanced Research and Development Authority for necessary expenses of advanced research, development, manufacturing, production, and purchase of diagnostic, serologic, or other COVID–19 tests or related supplies, and other activities related to COVID–19 testing at the discretion of the Secretary.

  • That of the amount appropriated under this paragraph in this Act, $22,000,000, shall be transferred to the ‘‘Department of Health and Human Services—Food and Drug Administration—Salaries and Expenses’’ to support activities associated with diagnostic, serological, antigen, and other tests, and related administrative activities.

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