Home 5 Lab Industry Advisor 5 Essential 5 September 2023 FDA Watch

September 2023 FDA Watch

by | Aug 31, 2023 | Essential, FDA-lir, Laboratory Industry Report

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 COVID-19 test to receive CLIA waiver
** 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.


  1. https://kaloramainformation.com/product/covid-19-testing-market-update-2023/
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231481
  3. https://www.cepheid.com/en-US/tests/respiratory/xpert-xpress-cov-2-flu-rsv-plus.html
  4. https://investors.bd.com/news-releases/news-release-details/bd-receives-510k-clearance-covid-19-influenza-ab-rsv-molecular
  5. https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223591.pdf
  6. https://www.biomerieux.com/us/en/journalists/press-releases/biofire-spotfire-respiratory-panel-mini-fda-clearance.html
  7. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-home-test-detect-both-influenza-and-covid-19-viruses
  8. https://www.fda.gov/media/165206/download
  9. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm


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
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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