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BARDA Seeking Submissions for New Coronavirus Dx Funding


NEW YORK – The Office of Biomedical Advanced Research and Development Authority (BARDA) is now seeking applications from diagnostics makers to support the development of tests for novel coronavirus 2019-nCoV.

On Tuesday, under the auspices of its Division of Research, Innovation & Ventures (DRIVe), BARDA launched an Easy Broad Agency Announcement, or EZ-BAA, funding solicitation that is specifically for diagnostics, enabling diagnostics developers to submit assays for funding.

In an interview, Rick Bright, the director of BARDA, noted that the applications will be reviewed by a panel of scientific and contracting experts, with up to $749,000 available for each project.

An additional full Broad Agency Announcement, or BAA, will likely be activated in the next few weeks, he said, which would enable distribution of additional funding. The total pool of funds that BARDA has available to support test development is also likely to grow as more funds are released across government agencies in response to the global 2019-nCoV outbreak.

The EZ-BAA process is simplified compared to past submission processes, Bright said. It requires a brief abstract, which will be reviewed quickly, with a contract able to be put in place within 30 days. "It might even be faster with the emergency response," he added.

The first solicitation prioritizes diagnostics on platforms with US Food and Drug Administration approval. The technology should have made it past the point of a non-clinical trial, Bright said, and should potentially be ready for emergency use authorization within 12 weeks.

"Our strategy right now is to make diagnostics technology available as widely as possible, to make sure people have a way of knowing whether or not they've been infected as quickly as possible," Bright said.

While the CDC is working closely with the FDA to expand the use of its test, "in parallel to that, BARDA will be working with companies with proven platforms to very quickly get the data needed on their platforms so they can put it in front of the FDA for consideration for an emergency use authorization," Bright explained. This will enable additional testing in more healthcare facilities across the US, he said.

In addition to the EZ-BAA, BARDA, a division of Health and Human Services, is also hosting a government-wide portal to channel 2019-nCoV inquiries from industry.

This "unprecedented approach" creates a single point of entry for companies to submit their technologies or ideas to the government, Bright said. The process will streamline interactions compared to past outbreak situations, when companies may have solicited BARDA, the National Institutes of Health, the Centers for Disease Control and Prevention, or the Department of Defense, or DARPA, individually.

"There are many different rabbit holes that a company can go down trying to make sure that the government is aware of their technology and its potential benefit in addressing the outbreak," Bright said.

A new government-wide partnership — part of the Medical Countermeasures Task Force — includes representatives from NIH, FDA, CDC, ASPER, DoD, and BARDA, Bright said, who will triage inquiries that come through its portal.

Companies can submit a single package to the portal, and all of the agencies can access it, he said. Task force working groups focused on diagnostics, vaccines, treatments and therapeutics, and clinical trials, will then follow up with companies on how to proceed.

"We're hoping this reduces a lot of the confusion companies have when they try to work with government," Bright said.

The portal is considered market research, and Bright said any ideas and technologies are of interest. "We want companies to submit any and every idea they have, at any stage of development," he said.

As funding becomes available, then the agencies will also begin putting out solicitations for funding proposals.

So far, there have been 35 submissions to the portal, which opened late last week. "We are already scheduling some meetings with companies that have submitted, so we can get more information about potential solutions," Bright said.

In general, he also noted that the past outbreaks have led to lessons learned in terms of ramping up — and following through on — support for new technologies. Coronaviruses are emerging more frequently now, Bright said, but projects that were begun for SARS and MERS fizzled when those outbreaks ended.

"We believe now is the time to make sure we finish the job, and that we have diagnostics, drugs, and vaccines for coronaviruses in place so that when the next one emerges, we're ready."