September 2023 FDA Watch
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
While demand has shrunk, COVID-19 lab testing isn’t going away any time soon. The global market for SARS-CoV-2 molecular and immunoassay tests may be approximately $25 billion in 2023, according to a report from diagnostics industry consulting firm Kalorama Information, making COVID-19 one of the largest single-disease in vitro diagnostic testing categories.1 Multiplex assays capable of simultaneously identifying and distinguishing COVID-19 from other respiratory viruses will likely command a large chunk of those future revenues, especially as we draw closer to flu season and the continued threat of a “tripledemic” from COVID-19, respiratory syncytial virus (RSV), and influenza.
Cepheid, BD, and Roche Nab 510(k) Clearances for COVID-19 Multiplex Tests
Three more COVID-19 combination tests recently obtained premarketing authorization from the FDA. On August 17, Cepheid received 510(k) clearance for its Xpert Xpress CoV-2/Flu/RSV plus assay that detects and differentiates between SARS-CoV-2, influenza A/B, and RSV, providing results for all four pathogens in 36 minutes, and results for SARS-CoV-2 alone in about 25 minutes. The assay was originally granted Emergency Use Authorization (EUA) in September 2021.2,3
On August 1, Becton Dickinson (BD) announced that the agency granted 510(k) clearance to its BD Respiratory Viral Panel for BD MAX™, a molecular RT-PCR assay capable of detecting and distinguishing between COVID-19, RSV, and influenza A/B in about two hours. The product has been on the US market since receiving EUA in February. The test also received CE marking in Europe in May.4
The FDA granted 510(k) clearance to an RT-PCR multiplex respiratory assay from Roche at the end of July, the cobas SARS-CoV-2 & Influenza A/B test designed to run on the firm’s cobas Liat PCR System.5
Long-Term Trends
The FDA has now granted premarket authorization to seven different multiplex COVID-19 respiratory tests, all in 2023. bioMérieux subsidiary BioFire Diagnostics has the distinction of securing the first clearance and becoming the only firm with 510(k) clearance for multiple test products.6 Two other multiplex tests have received EUA—the Lucira COVID-19 & Flu Home Test from now-bankrupt Lucira and LumiraDx’s RT-PCR test for SARS-CoV-2 and influenza A/B. Lucira’s offering, an at-home test kit that can be used without a prescription, was the first at-home COVID-19 multiplex test to gain EUA.7,8
All nine of the COVID-19 multiplex tests now on the US market are RT-PCR assays, with result turnaround times ranging from 15 minutes to three hours. The tests from DiaSorin, LumiraDx, Lucira, and Roche are limited to three pathogens—SARS-CoV-2, Influenza A, and Influenza B. Tests from bioMérieux, BD, Cepheid, and Hologic are also capable of detecting RSV. The bioMérieux BIOFIRE® SPOTFIRE® R test has the widest scope, with 15 pathogens targeted.
Multiplex Combination COVID-19 Tests Cleared by the FDA in 2023
| Company | Test | Modality | Pathogens Detected | Turnaround Time | Clearance Type |
|---|---|---|---|---|---|
| bioMérieux | BIOFIRE® SPOTFIRE® Respiratory Panel (SPOTFIRE® R) and System | RT-PCR | 15 different viral and bacterial pathogens | 15 minutes | 510(k) + CLIA waiver* |
| LumiraDx | LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete test | RT-PCR | SARS-CoV-2, Influenza A/B | 20 minutes | EUA |
| Becton Dickinson | BD Respiratory Viral Panel for BD MAX™ | RT-PCR | SARS-CoV-2, Influenza A/B, RSV | 2 hours | 510(k) |
| Lucira | Lucira COVID-19 & Flu Home Test | At-home, OTC, RT-PCR | SARS-CoV-2, Influenza A/B | 30 minutes | EUA** |
| DiaSorin | Simplexa COVID-19 & Flu A/B Direct | RT-PCR | SARS-CoV-2, Influenza A/B | 1 hour | 510(k) |
| bioMérieux | BIOFIRE® SPOTFIRE® R Panel Mini (SPOTFIRE® Mini) | RT-PCR | SARS-CoV-2, Influenza A/B, RSV, Rhinovirus | 15 minutes | 510(k) |
| Hologic | Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay | High-throughput RT-PCR | SARS-CoV-2, Influenza A/B, RSV | 3 hours | 510(k) |
| Roche | cobas SARS-CoV-2 & Influenza A/B | RT-PCR | SARS-CoV-2, Influenza A/B | 20 minutes | 510(k) |
| Cepheid | Xpert Xpress CoV-2/Flu/RSV plus | RT-PCR | SARS-CoV-2, Influenza A/B, RSV | 36 minutes | 510(k) |
** First multiplex COVID/Influenza A & B home test to get clearance for OTC use
Source: FDA 510(k) Premarket Notification database and company press releases.9
The Next Wave
Premarket authorization of multiplex tests represents the future of the COVID-19 market, particularly rapid at-home and point-of-care tests that can be sold over the counter. Currently, no such product has received 510(k) or De Novo authorization from the FDA. Having garnered EUA, the Lucira test seems best positioned to make the breakthrough to full premarketing authorization. However, with Lucira bankrupt, that might not come to pass.
References:
- https://kaloramainformation.com/product/covid-19-testing-market-update-2023/
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231481
- https://www.cepheid.com/en-US/tests/respiratory/xpert-xpress-cov-2-flu-rsv-plus.html
- https://investors.bd.com/news-releases/news-release-details/bd-receives-510k-clearance-covid-19-influenza-ab-rsv-molecular
- https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223591.pdf
- https://www.biomerieux.com/us/en/journalists/press-releases/biofire-spotfire-respiratory-panel-mini-fda-clearance.html
- https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-home-test-detect-both-influenza-and-covid-19-viruses
- https://www.fda.gov/media/165206/download
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
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Here are the other key new FDA clearances that were announced in the period from July to August 2023:
New FDA Approvals & Emergency Use Authorizations (EUAs)
| Manufacturer(s) | Product |
|---|---|
| Roche | 510(k) clearance for cobas SARS-CoV-2 & Influenza A/B point-of-care RT-PCR test for COVID-19 and influenza A/B |
| Foundation Medicine (Roche subsidiary) | FoundationOne®CDx test approved for use as a companion diagnostic for Janssen Biotech’s AKEEGA™ (niraparib and abiraterone acetate) |
| MiRXES | Breakthrough device designation for GASTROClearTM PCR test for early detection of gastric cancer |
| Abbott | 510(k) clearance for Alinity® h-Series hematology system |
| Abbott | 510(k) clearance for i-STATPTplus Cartridge prothrombin time test to quantify clot time of extrinsic coagulation pathway when activated by thromboplastin in non-anticoagulated whole blood for use with Abbott’s handheld i-STAT 1 analyzer |
| Abbott | 510(k) clearance for i-STAT CG8+ cartridge point-of-care glucose test system for the i-STAT 1 System for quantification of glucose in whole blood for diagnosis, monitoring, and treatment of carbohydrate metabolism disorders |
| Abbott | 510(k) clearance for Alkaline Phosphatase2 assay for quantitation of alkaline phosphatase in serum or plasma on ARCHITECT c System analyzers |
| QIAGEN | Clearance for therascreen PDGFRA RGQ PCR kit for use as companion diagnostic to detect mutation in platelet-derived growth factor receptor alpha (PDGFRA) gene associated with primary resistance to other drugs in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) |
| Trinity Biotech | 510(k) clearance for Premier Resolution System automated analyzer |
| Laboratory Corporation of America | Clearance for Clear Dx SARS-CoV-2 WGS v3.0 Test nanopore sequencing assay to detect SARS-CoV-2 |
| Beckman Coulter (Danaher subsidiary) | 510(k) clearance for DxC 500 AU Chemistry Analyzer |
| Becton Dickinson | 510(k) clearance for BD Respiratory Viral Panel for BD MAX™ combination COVID-19, influenza A/B, and RSV molecular test |
| Meridian Bioscience | Clearance for Premier® HpSA® FLEX™ assay for Helicobacter pylori in preserved and unpreserved stools |
| Numares Health | Clearance for AXINON® LDL-p Test System for measuring lipoproteins and identifying patients at risk for cardiovascular disease |
| AlphaDERA Labs | EUA for ALPHADx SARS-CoV-2 RT-PCR Test |
| Immunostics | EUA for Swab-N-Go Home Test COVID-19 Ag test |
| Siemens Healthineers | Breakthrough device designation for Enhanced Liver Fibrosis Test (ELF™) to aid diagnosis of advanced fibrosis in patients with nonalcoholic fatty liver disease |
| Siemens Healthineers | Clearance for Atellica CI Analyzer |
| Gradientech | Breakthrough Device designation for QuickMIC® rapid antibiotic susceptibility test system |
| Invivoscribe | Clearance for LeukoStrat® CDx FLT3 Mutation Assay for selecting patients with FLT3-ITD positive acute myeloid leukemia eligible for treatment with Daiichi Sankyo’s VANFLYTA® (quizartinib) |
| MeMed | Clearance for BV® test on whole blood samples for distinguishing between viral and bacterial cases |
New CE Marks & Global Certifications
Notable European CE certifications announced during the period:
New Approvals in Europe
| Manufacturer(s) | Product(s) |
|---|---|
| Theranica | Expansion of existing CE mark for Nerivio® system to include neuromodulation armband for migraine treatment |
| Palliare | Expanded approval of EVA15 insufflator and smoke evacuation system |
Other international clearances announced during the period:
| Manufacturer(s) | Country | Product(s) |
|---|---|---|
| Motus GI Holdings | Israel | Pure-Vu® EVS System to enhance visualization during colonoscopy |
| Roche | South Korea | Approval of Elecsys® β-Amyloid (1-42) CSF II (A β 42) and Elecsys® Phospho-Tau (181P) CSF (pTau181) CSF assays for Alzheimer’s disease |
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