Just as some manufacturers hasten to make tests available for the novel Wuhan coronavirus, FDA will convene with industry representatives Monday in hopes of developing a better "roadmap" for how diagnostics are evaluated during and potentially after emergencies.
The workshop was planned months before the Chinese outbreak to address the relatively few diagnostics that make the transition from emergency use authorization to full marketing status.
Collection of real-world data on safety and efficacy, still a relatively nascent concept for industry and regulators across medical devices and drugs, may be a key missing link.
"Often what happens is that you get those diagnostic tests out in the market, use them during an emergency, and then when the emergency is waning, they are not submitted for approval to FDA," said Danelle Miller, Roche Diagnostics' vice president of global regulatory policy and intelligence.
Miller is also the clinical diagnostics steering committee chair for the public-private Medical Device Innovation Consortium, which planned the meeting with FDA.
"So we started asking the question ... why does that happen?"
Regulators and manufacturers alike have recent lessons to draw from, given that HHS issued declarations authorizing emergency use of diagnostics for Ebola virus in 2014 and Zika virus in 2016. HHS issued a similar declaration for the coronavirus Friday, following the World Health Organization officially labeling the outbreak a public health emergency, the sixth such declaration since the designation was created in 2005.
FDA last year touted the first full marketing authorizations for an Ebola diagnostic, from OraSure Technologies, and a Zika diagnostic, from InBios International. Both were greenlighted via the De Novo pathway after originally being allowed under FDA's emergency use authorization (EUA) pathway, for which FDA finalized guidance in 2017.
While EUA serves a clear purpose in emergency cases with no available diagnostic alternatives, a transition to full marketing status reflects additional data to back safety and effectiveness, giving healthcare providers further assurance, FDA said. Since the InBios De Novo, two other Zika tests have upgraded from EUA via 510(k) submissions.
Roche is among the companies that came out with tests in response to both Ebola and Zika.
"Decisions regarding taking a test to commercialization depend on considerations of medical value, impact on public health, and the business case," said Angela Tucker, vice president of regulatory affairs at Roche Molecular Diagnostics, in an email to MedTech Dive.
Once an emergency is contained, the "population-based medical value assessment and the business case for commercializing a test may vanish as the epidemic resolves and as test use diminishes."
The potentially high cost of developing the clinical data for submission may be a deterrent, Miller said, which is why a clearer understanding between FDA and manufacturers on how to collect and use real-world data while an emergency is playing out could be a gamechanger.
Key questions include: how can stakeholders ensure data is collected from the outset of a crisis? And if a product is modified along the way, can earlier real-world data still be turned into viable evidence? MDIC may follow up the meeting with pilot projects tackling these issues.
It's unclear whether FDA and industry could apply any ideas that emerge Monday to the current coronavirus. "It may be too soon, but that would be my hope," Miller said.
FDA Commissioner Stephen Hahn said in a statement Monday the agency had "begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation."
As of Monday, FDA said there were no commercially available products authorized to detect the novel coronavirus, but was open to engaging with diagnostic sponsors on potential EUAs. Roche said Thursday it's trying to distribute what it believes is the first commercial test in China, and a spokesperson confirmed that the company is pursuing pre-EUA with FDA for a potential test.
FDA is working closely with other government agencies, particularly after creating a tri-agency joint task force a year ago to expedite development and deployment of diagnostics in "clinical and public health laboratories" during emergencies. CDC offers epidemiology expertise to labs involved in responding to the emergency, FDA holds authority to grant emergency use authorizations to diagnostic tests, and CMS oversees lab compliance with CLIA.
One impetus in creating the task force was that labs had expressed confusion about how to implement EUA-designated tests while maintaining CLIA compliance. If FDA ultimately issues EUAs to coronavirus diagnostics, clinical labs could become involved in the emergency response.
“In any outbreak, CDC laboratories, supported by state public health laboratories, have primary responsibility for diagnosing patients,” Julie Khani, president of the American Clinical Labs Association, said in a statement shared with MedTech Dive.
“Should the need arise to test larger numbers of patients, commercial laboratories may be called upon to provide additional testing capacity. Historically, ACLA member laboratories have provided some surge capacity for other outbreaks, such as Zika and SARS.”
Trade association AdvaMed is also preparing to jump into action, both from its U.S. and China locations. It's already in communication with group purchasing organizations on possible supply chain challenges. AdvaMed is tracking potential shortages of products listed by the Chinese government as essential to emergency response, including medical protective clothing and masks, disposable isolation gowns and gloves, and non-contact infrared thermometers.
This story was updated to reflect that HHS declared a public health emergency regarding the novel coronavirus.
