Entering the endemic: What's next for COVID testing?

Though the Biden administration is set to declare an official end to the COVID-19 public health emergency this May, that won’t necessarily bring immediate changes in the U.S. landscape of coronavirus tests, treatments and vaccines.

For many, the onset of the pandemic brought a crash course in fine regulatory distinctions: In the time since the FDA granted its first green light for a commercially developed test in March 2020—a molecular diagnostic developed by Roche, with an application that sailed through the agency in less than 24 hours—the government has largely relied on emergency use authorizations, given out under newly bestowed pandemic powers.

The agency has repeatedly said that tests granted EUAs—which have been expedited to hospital labs and pharmacies and mailed to people’s homes in the years that followed—have not been officially approved or cleared. Even today, hardly any COVID tests have received the FDA’s full regulatory blessing since a kit developed by BioFire Diagnostics first made the cut in March 2021.

So what happens when the public health emergency comes to a close May 11? According to the FDA, any transition will take time—and will rely on yet another regulatory distinction. 

Under section 319 of the Public Health Service Act, a public health emergency declaration enables the Department of Health and Human Services (HHS) to investigate a spreading disease or disorder and support research into its causes and potential treatments by issuing grants or signing contracts with private companies.

Emergency product authorizations at the FDA, however, fall under a separate category. EUA declarations are governed by Section 564 of the Federal Food, Drug and Cosmetic Act, and the FDA says the authority granted by an EUA declaration—which allows tests, treatments and vaccines to reach the public faster, especially when there are no other options—generally continues until it is terminated by the HHS secretary, and with public notice in advance.

“As we have recognized during the entire COVID-19 response, continued flexibility will be appropriate—while maintaining necessary oversight within our regulatory authorities under applicable laws—to support stakeholders during such transitions, while maintaining our high standards to protect consumers,” the FDA wrote in an FAQ on its website, updated after the White House’s Jan. 30 announcement.

The agency previously said it would begin adopting a new regulatory stance for the future of COVID tests last fall and has started nudging product developers back toward the old ways. After granting more than 430 emergency authorizations during the pandemic, the FDA said it now plans to review only a small subset of applications for EUAs—and that all companies should instead pursue de novo classifications or 510(k) clearances. 

Meanwhile, President Joe Biden reiterated in his State of the Union address this week that “soon we’ll end the public health emergency” but that the government still needs “to monitor dozens of variants and support new vaccines and treatments. And Congress needs to fund these efforts and keep America safe.”

But changes in regulatory authority aren't the only factors that may see tests stay on the market. After months of predictions that this time would come, sales of COVID diagnostics among testmakers have dropped precipitously in recent quarters. 

This month, Thermo Fisher reported a two-thirds decline in COVID-related revenues year over year, bringing in a mere $3.11 billion in 2022 sales compared to the massive $9.23 billion haul it collected over the course of 2021. 

Hologic posted $127 million in COVID assay revenue for the first quarter of its fiscal year, but the company expects total annual test sales to top out at $225 million. And Abbott, with its card-based BinaxNow antigen test, has forecast about $2 billion in COVID-related sales, less than a quarter of the previous year’s total.

While the numbers alone appear to put things in dire straits, the losses have been long planned for, and those companies also reported gains in their core, non-COVID product segments.

Still, that doesn’t mean testmakers are ready to completely abandon the field. Companies like BD are looking to expand their reach with combination tests that can screen for the coronavirus as well as diseases like the flu—including through what may end up being the FDA’s last call for EUAs.

This week, the company received an emergency authorization for its BD MAX lab test that simultaneously checks a sample for the coronavirus, influenza A and B, and respiratory syncytial virus, aimed at future flu seasons where COVID continues to linger. Even now in the U.S., weekly new COVID cases hover around 300,000 and weekly death rates around 3,000.

“Given the dynamic nature of testing trends as we enter the endemic, some COVID-19 products more than others will be relevant in the variety of care settings we serve. We continue to monitor demand for COVID-19 testing and will pursue regulatory clearances for those products that continue to command market interest, both in the antigen and molecular testing modalities,” Kamni Vijay, general manager of BD’s point-of-care integrated diagnostic segment, told Fierce Medtech. 

BD has also recently submitted information to the FDA for an EUA for its first at-home COVID-19 and influenza A and B combo test, Vijay said.

“The pandemic has demonstrated that the market has a strong appetite for conducting tests in the home, and there is ongoing opportunity to explore how to best serve this care setting with future diagnostic test products,” she added.