FDA Watch

Respiratory Panel Tests Flow from EUA Pipeline Ahead of Flu Season

The robust COVID-19 testing EUA pipeline has opened up a new opportunity for companies that produce multi-analyte panels capable of detecting not only the SARS-CoV-2 virus but other respiratory viral infections. And with the approach of flu season, half a dozen of these panel tests have reached the U.S. market with more to follow.

The New FDA Multi-analyte Testing Policy

As it customarily does, the FDA signaled its new policy of granting EUA to panel tests bundling SARS-CoV-2 with other respiratory viruses via informal guidance by posting a new Q&A to its website Questions & Answers for COVID-19 testing labs and test manufacturers. The new QA, which was posted on Sept. 9, notes “the overlap in signs and symptoms between SARS-CoV-2 and other respiratory viral infections, including influenza.” Multi-analyte panels capable of detecting and sorting out different viruses “are useful when multiple respiratory pathogens are circulated at the same time, as is expected with the upcoming flu season.”

The FDA also listed the factors it would consider in deciding whether to issue an EUA for such tests, including:

  • The extent to which the test aids differential diagnosis;
  • Whether the proposed use meets the requirements for the public health emergency declaration; and
  • The approval or clearance status of the individual tests within the panel.
Multi-Analyte Respiratory Panel Laboratory Tests with EUA Clearance
As of Sept. 29, the FDA has awarded EUA to the following multi-analyte respiratory panel tests:

  • QiaStat-Dx Respiratory SARS-CoV-2 Panel (Qiagen)
  • BioFire COVID-19 Test (BioFire Defense)
  • BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics)
  • Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (U.S. Centers for Disease Control and Prevention)
  • Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on Cobas Liat System (Roche)
  • Xpert Xpress SARS-CoV-2/Flu/RSV test (Cepheid)

Here are some of the other key FDA EUAs and approvals announced in September:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Clear Labs EUA for Clear Dx SARS-CoV-2, first nanopore sequencing-based test for SARS-CoV-2 with EUA
Quadrant Biosciences EUA for Clarifi COVID-19 Test Kit
KimForest Enterprise EUA for SARS-CoV-2 Detection Kit v1
Assure Tech EUA for Assure COVID-19 IgG/IgM Rapid Test Device, first antibody point of care assay to detect previous SARS-CoV-2 infection with EUA
Vela Diagnostics EUA for ViroKey SARS-CoV-2 RT-PCR Test v2.0
GK Pharmaceuticals Contract Manufacturing Operations (GK CMO) EUA for GK Accu-Right SARS-CoV-2 RT-PCR Kit
Shenzhen New Industries Biomedical Engineering (SNIBE) EUA for Maglumi 2019-nCoV IgM/IgG test
Accelerate Diagnostics 510(k) clearance for enhancements to Accelerate Pheno system
Hologic EUA for Aptima SARS-CoV-2 assay
Abbott Laboratories EUA for BinaxNow COVID-19 Ag Card, a SARS-CoV-2 antigen test that doesn’t require an analyzer to read results
Color Genomics EUA for Color COVID-19 Self-Swab Collection Kit
Thermo Fisher Scientific Premarket approval for Oncomine Dx Target Test as companion diagnostic for pralsetinib (Gavreto) drug developed by Blueprint Medicines to identify RET fusions in metastatic non-small cell lung cancer patients
Roche Expanded clearance for CINtec Plus Cytology test for use in patients with human papillomavirus
Roche EUA for Cobas SARS-CoV-2 & Influenza A/B test
Roche 510(k) clearance for Cobas test for BK virus to run on Cobas 6800 and 8800 Systems
Roche Clearance for Cobas HIV-1/HIV-2 Qualitative Test on Cobas 6800 and 8800 Systems
BioCheck EUA for BioCheck serological SARS-CoV-2 IgM and IgG test kits
Verily Life Science EUA for Verily COVID-19 RT-PCR Test
DiaSorin Clearance for Simplexa Flu A/B and RSV Direct Gen II kit
BillionToOne EUA for qSanger-COVID-19 sequencing-based SARS-CoV-2 test
Sugentech EUA for SGTi-flex COVID-19 IgG serological test
Bioeksen R&D Technologies EUA for Bio-Speedy Direct RT-qPCR SARS-CoV-2 test
Detectachem EUA for MobileDetect Bio BCC19 Test Kit
Optolane Technologies EUA for Kaira 2019-nCoV Detection Kit
Color Genomics EUA for COVID-19 Test Unmonitored Collection Kit
Mammoth Biosciences EUA for SARS-CoV-2 DETECTR Reagent Kit, a CRISPR-based RT-LAMP test
TBG Biotechnology EUA for TBG SARS-CoV-2 IgG/IgM Rapid Test Kit
T2 Biosystems EUA for T2SARS-CoV-2 panel
HelixBind Breakthrough Device Designation for RaPID/BSI test for bloodstream infections associated with sepsis
Foundation Medicine Clearance for s FoundationOne Liquid CDx, a multi-cancer comprehensive liquid-biopsy test, for multiple companion diagnostic indications including one for prostate cancer and three for lung cancer

New CE Marks & Global Certifications
Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Manufacturer(s) Product(s)
BGI Genomics Two different multiplexed tests for SARS-CoV-2 and influenza A/B
DiaSorin Molecular Simplexa COVID-19 Direct test
Cytek Biosciences Cytek Northern Lights flow cytometer
Eurobio Scientific EBX 042 FluCoSyn test
GenMark Diagnostics ePlex Respiratory Pathogen Panel 2
ProciseDx Procise IFX and Procise ADL tests measuring infliximab and adalimumab levels
Omega Diagnostics Mologic’s COVID-19 lateral flow antibody test to be marketed under the Omega Visitect brand
Novacyt Winterplex PCR-based respiratory panel differentiating SARS-CoV-2 from common winter infections

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Yourgene Health Australia Therapeutics Goods Association approval of Iona Nx NIPT workflow as a Class 3 medical device

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