FDA Watch

Agency to Provide Emergency Clearance for Multi-Analyte Respiratory Panels

We are now seven months into the COVID-19 public health emergency and flu season is rapidly approaching. Several diagnostics test producers have responded to this convergence by creating new multi-analyte tests that are capable of detecting (and differentiating) not only SARS-CoV-2 but also influenza and other respiratory viral infections. And while the U.S. Food and Drug Administration (FDA) has issued emergency use authorization (EUA) for SARS-CoV-2 assays, it had previously been unclear whether it would do the same for the multi-analyte tests. But now the FDA has confirmed that, yes, it will provide EUA for these tests.

As it customarily does, the FDA initiated this new policy not via regulation but informal guidance by posting a new Q&A to its website Questions & Answers for COVID-19 testing laboratories 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.” Tests that can kill two birds with one stone (our phrase, not the FDA’s) are also an efficient use of resources during the pandemic.

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;
  • The panel’s suitability current patient testing recommendations by public health authorities; and
  • The approval or clearance status of the individual tests in the panel.
Multi-Analyte Respiratory Panel Laboratory Tests with EUA Clearance

As of Sept. 16, the FDA has awarded EUA to the following multi-analyte respiratory panel tests (in chronological order of issuance):

  • 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)

 


Here are other key new FDA EUAs and clearances announced in late August through mid-September:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
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 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

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