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June 2023 FDA Watch

by | Jun 1, 2023

So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.

BioMérieux and Hologic Get Early Jump in Post-PHE US Multiplex Virus Testing Market

Even though the COVID-19 public health emergency (PHE) is over, the worldwide market for immunoassay and molecular COVID-19 testing is still expected to reach roughly as high as $25 billion in 2023,1 according to a new report from diagnostics industry consulting firm, Kalorama Information.2 At those numbers, COVID-19 would remain among the bigger single-disease categories in in vitro diagnostic (IVD) testing.

However, early indications suggest that, at least in the US, many of the post-PHE COVID-19 test products will be panels designed for simultaneous detection of and differentiation between multiple respiratory viruses. The FDA has already granted premarket authorization for four different COVID-19 combination respiratory tests in 2023, including two in May.

CLIA Waiver for BIOFIRE® SPOTFIRE® Respiratory Panel Mini

BioMérieux subsidiary BioFire Diagnostics has staked out an early claim for leadership in post-PHE COVID-19 testing. In early February, the FDA simultaneously granted 510(k) clearance for the BIOFIRE® SPOTFIRE® System—a modular platform for point-of-care molecular syndromic testing—and CLIA waiver for the SPOTFIRE® Respiratory (R) Panel for 15 respiratory pathogens, including SARS-CoV-2, to run on the newly approved SPOTFIRE® System.3 BioFire made headlines again on May 9 by announcing CLIA waiver for the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini for detecting SARS-CoV-2, respiratory syncytial virus (RSV), influenza A and B, and rhinovirus—the five most common viruses that cause upper respiratory tract infections.4

According to an earlier parent company press release, SPOTFIRE® is the first FDA-cleared PCR system to provide results in under 20 minutes “and can run both a large multiplex respiratory test in the 12-25 pathogen target range, and a small multiplex respiratory test in the three to five pathogen target range.” The new product clearances are designed to expand the company’s presence in the US outpatient market, the press release added.5

Hologic Multiplex Respiratory Panel Nabs 510(k) Clearance

On May 18, Hologic announced that its RT-PCR test for SARS-CoV-2, RSV, and influenza A and B received 510(k) clearance from the FDA. Developed with $14.8 million in funding from the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), the test is designed for use on the firm’s Panther Fusion® high-throughput instrument capable of processing more than 1,000 tests per day. Hologic also announced the simultaneous launch of a collection kit called RespDirect™ that labs can use to load samples directly into the Panther Fusion® system without the need for uncapping or specimen transfer, which may compromise accuracy.6

Despite a roughly 29 percent decline year over year, COVID-19 testing still generated $71 million in revenue in Q2 2023 for Hologic: the company is clearly in the SARS-CoV-2 testing market for the long haul.7 Last November, the firm secured a $19 million contract to align both the Panther Fusion® multiplex test and the Aptima® SARS-CoV-2 assay, which first received EUA clearance in May 2020, with FDA IVD standards.8

DiaSorin also Breaks into the US Multiplex COVID-19 Market

DiaSorin is the other company that has established a foothold in the long-term US market for COVID-19 molecular combination respiratory assays. On March 17, the Italian firm announced it had been granted FDA 510(k) premarket authorization for its Simplexa™ COVID-19 & Flu A/B Direct test, a multiplex RT-PCR assay run on the DiaSorin LIAISON® MDX instrument for detecting and differentiating between SARS-CoV-2 and influenza A and B infections.9


    1. https://kaloramainformation.com/blog/despite-declines-covid-19-still-a-large-ivd-market/

    1. https://kaloramainformation.com/product/covid-19-testing-market-update-2023/

    1. https://www.biomerieux.com/us/en/journalists/press-releases/fda-clearance-clia-waiver-biofire-spotfire-bioMerieux.html

    1. https://www.biomerieux.com/corp/en/journalists/press-releases/CLIA-waiver-BIOFIRE-SPOTFIRE-R-Panel-Mini.html

    1. https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2023/releases/PR_SPOTFIRE_R-Mini_Panel_Clearance_FDA__bioM%C3%A9rieux_20230413.pdf.coredownload.inline.pdf

    1. https://investors.hologic.com/press-releases/press-release-details/2023/Hologic-Announces-FDA-Clearance-of-Panther-Fusion-SARS-CoV-2Flu-ABRSV-Assay/default.aspx

    1. https://investors.hologic.com/press-releases/press-release-details/2023/Hologic-Announces-Financial-Results-for-Second-Quarter-of-Fiscal-2023/default.aspx

    1. https://investors.hologic.com/press-releases/press-release-details/2022/Hologic-Announces-Contract-with-BARDA-to-Support-IVD-Approval-of-COVID-Assays/default.aspx

  1. https://diasoringroup.com/sites/diasorincorp/files/allegati_pressrel/diasorin_simplexa_covid_flu_assay_received_u.s._fda_510k_clearance.pdf


Here are the key new FDA clearances announced between late April and late May 2023:

New FDA Approvals & Emergency Use Authorizations (EUAs)

Hologic510(k) clearance for a multiplex respiratory panel for SARS-CoV-2, influenza A and B
Thermo Fisher ScientificBreakthrough device designation for B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR immunoassays for preeclampsia run on firm’s B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyzer
Nano-DitechEUA for Nano-Check COVID-19 Antigen At-Home Test lateral flow assay
Becton Dickinson510(k) clearance for BD Kiestra imaging application AI test for methicillin-resistant Staphylococcus aureus (MRSA) bacterial growth
Singlera GenomicsBreakthrough device designation for PDACatch assay, a DNA methylation-based liquid biopsy test for detection of pancreatic adenocarcinoma in high-risk individuals
BioMérieuxCLIA waiver for BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini for SARS-CoV-2, influenza A and B, respiratory syncytial virus, and rhinovirus
QuidelOrthoFrom EUA to De Novo clearance for VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and Calibrator
Nucleix510(k) clearance for Bladder EpiCheck® cancer recurrence test
Access Medical LaboratoriesEUA for Global Direct RT-PCR Test for SARS-CoV-2
Drexel University College of MedicineEUA for SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay
Foundation MedicineClearance for FoundationOne® Liquid CDx assay as companion diagnostic for Takeda’s EXKIVITY® (mobocertinib) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Kurin Inc.510(k) clearance for Kurin® blood culture collection set with Kurin Lock Technology
TempusPremarket clearance for xT CDx 648-gene next-generation sequencing test for solid tumor profiling in cancer patients with solid malignant neoplasms
University of Massachusetts, AmherstEUA for ICTC SARS-CoV-2 RT-PCR Assay
Promis DiagnosticsBreakthrough device designation for EarlyTect® BCD test for bladder cancer via qualitative detection of PENK methylation
YourBio Health510(k) clearance for Touch Activated Phlebotomy (TAP)® Micro Select remote bladeless blood collection device for microcapillary blood diagnostic testing
Mawi DNA Technologies510(k) clearance for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) for collection, transport, and storage of upper respiratory tract and saliva samples at ambient temperature
MedArbor DiagnosticsEUA for MedArbor Diagnostics SARS-CoV-2 Assay
Princeton BioMeditech CorpEUA for Status COVID-19 Antigen Rapid OTC Test for Home Use

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New Approvals in Europe

Regen LabREGENKIT® preparation of platelet-rich plasma (PRP)
Regen LabCELLULAR MATRIX fig®, a combination of PRP and hyaluronic acid (HA)
Regen LabArthrovisc® comprised of syringes filled with HA
InvivoscribeLeukoStrat® CDx FLT3 Mutation Assay for acute myelogenous leukemia
SphingoTecsphingotest® penKid® assay for helping diagnose acute kidney injury

Other international clearances announced during the period:

NovaradIndonesiaVisAR augmented reality surgical navigation system

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