Cancer Institute Tasks $19 Million for New Virus Antibody Tests

May 15, 2020, 5:55 PM

The National Cancer Institute is building a national network of antibody testing centers, potentially spurring more and better coronavirus tests critical to guiding states on how they can reopen.

The institute plans to use $19 million from the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139) to fund Serological Sciences Centers of Excellence tasked with improving or developing new serological tests for coronavirus antibodies, according to a Friday notice. Centers of excellence are National Institutes of Health programs that build research infrastructure to address underfunded areas or significant challenges that have been well recognized.

The centers will build on work the cancer institute has been doing to help the Food and Drug Administration validate serological tests, which can tell who’s been previously infected. That helps communities figure out how much the virus has spread, who can potentially donate plasma, and what steps to take next, according to the FDA.

The FDA tightened its oversight of the tests earlier this month over concerns about their reliability.

“Antibody tests have become a very hot topic,” Angela M. Caliendo, a Brown University professor and secretary of the Infectious Diseases Society of America Board of Directors, said during the society’s media briefing on testing. “We don’t have enough information about the performance of these tests to know ideally how to use them.”

There are several types of antibodies. Some tests measure the total antibody while others measure a type of antibody known as immunoglobulin, which tends to come up later in the infection, Caliendo said. The FDA has allowed emergency use of about a dozen antibody tests, but there are others that haven’t gone though FDA’s oversight process. “Until we fully understand the performance of these assays, we won’t understand how best to use them,” Caliendo said.

The NCI stepped in to help validate tests because it has an advanced serology laboratory in Frederick, Md., and expertise in developing HPV vaccines. The centers of excellence will be coordinated through the Frederick National Laboratory for Cancer Research, according to the notice.

The institute will establish four to eight centers across the country that will develop a comprehensive research program and provide four to six additional awards for specific projects. The official funding announcement will likely publish in June, and applications will likely be due by July, the NCI said.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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