FDA Keeps COVID-19 EUA Pipeline Open While Working toward Transition
HHS secretary takes action to ensure that EUAs remain in effect until the “significant potential” for a COVID-19 PHE no longer exists.
As expected, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra took action to ensure that COVID-19 products that have received FDA Emergency Use Authorization (EUA) remain valid after the public health emergency (PHE) officially ends on May 11.1,2 On March 15, the secretary amended the declaration (issued under Section 564 of the Federal Food, Drug, and Cosmetic Act [FD&C Act]) giving the FDA authority to approve COVID-19 lab tests, personal protective equipment, medical devices, and drug and biological products so that it remains in effect until the “significant potential” for a COVID-19 PHE no longer exists.3,4 The circumstances that prompted HHS to issue the original 564 EUA declaration continue to exist, as does the potential for a future COVID-19 PHE, the secretary noted.
Translation: Labs and other producers that have received EUA for COVID-19 products will, in fact, get a breathing period to either make an exit or seek full regulatory approval for their products. They’ll also get ample notice when the secretary does decide to pull the plug. To terminate an EUA declaration under the FD&C Act, the secretary must first notify the public by publishing a notice in the Federal Register. The EUA declaration would then remain in effect for a reasonable period after publication of the notice to allow for “proper dispositioning,” according to the FDA.5
QuidelOrtho Premarket Approval Opens New Pathway for COVID-19 Antigen Tests
Meanwhile, the FDA has already begun the process of weaning producers away from EUA status. So far, six different molecular SARS-CoV-2 tests have received full premarketing approval, the most recent being the DiaSorin Simplexa COVID-19 & Flu A/B Direct assay which received 510(k) clearance on March 17.6
The transition process made a significant advance on March 8 when the FDA provided De Novo clearance for QuidelOrtho’s Sofia 2 SARS Antigen + FIA test, making it the first antigen test to win promotion from EUA to premarketing approval.7 The action was more than symbolic. In announcing the QuidelOrtho clearance, the FDA revealed that it was establishing a new 510(k) Class II regulatory classification covering “simple devices” that detect SARS-CoV-2 viruses at the point of care or via home use. The practical implications of this for device makers are significant. That’s because the 510(k) pathway allows for clearance of new devices that can be demonstrated as being of substantial equivalence to a “predicate” or existing device.8
The New Class II Regulatory Classification for Simple SARS-CoV-2 Detection Devices
Here’s how the FDA describes the “simple devices” that qualify under the new Class II classification:
“Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings. A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory.”9
FDA Dashes Veru’s Hopes for COVID-19 Treatment EUA
Meanwhile, one of the biggest stories of the month was a product that didn’t get EUA from the FDA, namely, Veru’s sabizabulin treatment for COVID-19. On March 2, the biopharma firm announced that the agency had declined on EUA clearance, at least temporarily, and recommended a confirmatory Phase 3 trial instead.10
For Veru, it was a bitter blow. Last April, the firm reported that sabizabulin, a novel microtubule disruptor treatment for hospitalized adult patients with moderate to severe COVID-19 at high risk for acute respiratory distress syndrome (ARDS), reduced deaths by 55 percent, compared to a placebo.11 Armed with that data, Veru decided to gamble and end its phase 3 trial early and seek FDA approval. The future looked rosy, with Veru’s stock price nearly doubling to $10 per share. Alas, Veru’s roll of the dice came up snake eyes. Word of the setback, temporary as it might be, caused Veru’s shares to slide 38 percent from $3.78 to $2.35 per share within a matter of hours.12
The FDA accompanied the bad news with encouragement for Veru. We’re committed to keep working with you in developing sabizabulin, the agency essentially said. Its advice: Do the confirmatory phase 3 clinical study but make allowance for “appropriate time frames for interim analyses so that—should a strong efficacy signal again be observed—the trial could be stopped in an efficient time frame.”10 So, it’s not completely back to the drawing board for Veru.
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Here are some of the key new FDA EUAs and clearances that were announced in March 2023:
New FDA Approvals & Emergency Use Authorizations (EUAs)
| Manufacturer(s) | Product |
| Rapid Novor | CLIA waiver for EasyM, for a blood test for monitoring minimal residual disease (MRD) activity |
| DiaSorin | 510(k) clearance for Simplexa COVID-19 & Flu A/B Direct, a molecular assay for detecting and differentiating between SARS-CoV-2 and influenza A and B infections |
| Cue Health | EUA for Cue Mpox (Monkeypox) Molecular Test for use in point-of-care (POC) setting |
| Becton Dickinson | 510(k) clearance for BD Vaginal Panel high-throughput assay to detect vaginitis run on firm’s BD Cor System |
| Becton Dickinson | Clearance for BD Onclarity human papillomavirus (HPV) test for use with Hologic ThinPrep Pap test |
| Visby Medical | 510(k) clearance and CLIA waiver for Visby Medical Sexual Health PCR test for sexually transmitted infections in women |
| Quest Diagnostics | EUA for Quest COVID-19 Nucleic Acid Test Collection Kit for self-collection of anterior nasal swab specimens for tests detecting SARS-CoV-2 nucleic acid |
| QuidelOrtho | De Novo clearance for Sofia 2 SARS Antigen+ FIA, first COVID-19 antigen test to receive traditional premarket review authorization |
| Abbott | Clearance for lab test for concussions run on firm’s Alinity i instrument |
| InBios International | De Novo clearance for Active Anthrax Detect Plus Rapid Test to diagnose inhalation anthrax at point of care |
| Biocartis | 510(k) clearance for Idylla MSI Test, a microsatellite instability (MSI) assay to screen for Lynch syndrome in colorectal cancer patients |
| Lucira Health | EUA for Lucira COVID-19 & Flu Home Test, first at-home diagnostic test to detect and differentiate among influenza A and B and SARS-CoV-2 to get EUA for over-the-counter (OTC) use |
| Roche | Clearance for Roche Ventana PD-L1 (SP263) assay as companion diagnostic with Regeneron’s Libtayo (cemiplimab) in lung cancer patients |
| Chembio Diagnostics | CLIA waiver for DPP HIV-Syphilis System single-use, dual-target test for HIV 1/2 and the syphilis-causing bacteria Treponema pallidum |
| GenBody | EUA for GenBody COVID-19 Ag Home Test for OTC use |
| Mologic | EUA for COVI-Go SARS-CoV-2 Ag Self-Test |
| Spectrum Solutions | 510(k) clearance for SDNA Saliva Collection Device for use in microbial nucleic acid storage and stabilization |
New CE Marks & Global Certifications
Notable European CE certifications announced during the period:
New Approvals in Europe
| Manufacturer(s) | Product(s) |
| Oxford Gene Technology | Eight of the firm’s CytoCell fluorescence in situ hybridization (FISH) probes |
| MGI Tech | DNBSeq-G99 sequencer platform |
Other international clearances announced during the period:
| Manufacturer(s) | Country(ies) | Product(s) |
| BGI Genomics | Australia | SARS-CoV-2, influenza A, and influenza B multiplexed test |
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