FDA Watch

Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification

On Oct. 13, the FDA issued new guidance on molecular diagnostic tests for influenza and respiratory syncytial virus (RSV). The upshot of the guidance is to temporarily allow makers of flu and RSV tests that the agency has already cleared to make certain modifications to those products without submitting 510(k) premarket notification in the interest of making the tests more widely available while also not using up reagents needed for SARS-CoV-2 testing.

Background

There’s significant overlap in warning signs and symptoms between SARS-CoV-2 and other
respiratory viral infections, including influenza and RSV, the guidance explains. “Increased availability of molecular influenza tests during the COVID-19 pandemic is important due to the similarity in symptoms between COVID-19 and the seasonal influenza.” The guidance also notes that because of this overlap in symptoms, molecular influenza tests are often offered as part of a panel of tests including RSV.

Diagnostic tests for SARS-CoV-2 and other respiratory viral infections generally use many of the same components. For example, the same specimen collection devices and transport media required to perform many FDA-cleared molecular influenza tests are also needed for most molecular diagnostic SARS-CoV-2 assays. And, of course, those devices and media are currently in short supply.
Accordingly, the guidance states that for the duration of the COVID-19 public health emergency, the agency “does not intend to object” to the addition of certain transport media types and sample types for previously FDA-cleared molecular flu and RSV tests. Such modifications won’t require submission of a 510(k) premarket notification so long as they don’t “create undue risk in the light of the public health emergency.” The policy doesn’t apply to tests and devices for other viruses, antigen-based tests, multiplex respiratory panels, or multiplex molecular tests that include SARS-CoV-2 targets, the guidance specifies.

Modifications Not Requiring Premarket Notification

Specifically, tests previously indicated for use with samples collected in viral transport media may now be modified to use samples collected in sterile phosphate buffered saline, “including molecular grade PBS and other similar formulations such as Dulbecco’s PBS,” as well as into sterile normal saline. Also on the agency’s “does-not-intend-to-object” list are modifications to add healthcare provider-collected anterior nares or mid-turbinate specimens, provided that the test is already cleared for use with nasopharyngeal swab samples.

Modifications Still Requiring Premarket Notification

The guidance also cites specific modifications that the agency believes would create undue risk and thus wouldn’t be subject to the temporary relaxation of premarket notification requirements, including:

  • Adding a sample type not identified in the examples cited as not creating undue risk to an FDA-cleared molecular influenza and RSV test;
  • Adding an indication for use with self-collected specimens to an FDA-cleared molecular influenza and RSV test;
  • Adding a transport media not identified in the not-creating-undue risk examples to an FDA-cleared molecular influenza and RSV test; or
  • Adding an over-the-counter (OTC) use or new patient population (e.g., pediatrics) to the indication for an FDA-cleared molecular influenza and RSV test.

The guidance also instructs developers to provide labeling information to help users understand whatever modifications have been made and to verify and validate performance of the modified test.

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

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Celltrion EUA for Sampinute COVID-19 Antigen MIA magnetic force-assisted electrochemical sandwich immunoassay
Foundation Medicine Clearance for FoundationOne Liquid CDx test as companion diagnostic for three new targeted cancer therapies, including alpelisib (Novartis’ Piqray) in advanced or metastatic breast cancer, rucaparib (Clovis Oncology’s Rubraca) in advanced ovarian cancer, and alectinib (Genentech’s Alecensa) in metastatic non-small cell lung cancer
Foundation Medicine Clearance for FoundationOne CDx test as companion diagnostic for use with larotrectinib (Bayer’s Vitrakvi) to identify cancer patients with neurotrophic receptor tyrosine kinase fusions
Scopio Labs 510(k) clearance for X100 hematology imaging and analysis system and Full Field Peripheral Blood Smear application
Abbott Laboratories EUA for SARS-CoV-2 IgM antibody test
Thermo Fisher Scientific EUA for OmniPath COVID-19 Total Antibody ELISA Test
DNA Genotek EUA for OMNIgene·ORAL OM-505 and OME-505 saliva collection devices
Clinical Enterprise EUA for EmpowerDX At-Home COVID-19 PCR Test Kit
LumiraDx EUA for SARS-CoV-2 RNA STAR Complete assay
MiR Scientific Breakthrough Device Designation for MiR Sentinel PCC4 Assay for prostate cancer
Spectrum Solutions EUA for SDNA-1000 Saliva Collection Device
Access Bio EUA for CareStart COVID-19 Antigen test
Genalyte EUA for Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2
Beckman Coulter EUA for Access SARS-CoV-2 Immunoglobulin M (IgM) assay
Beckman Coulter EUA for Access Interleukin-6 (IL-6) immunoassay
Seasun Biomaterials EUA for AQ-TOP COVID-19 Rapid Detection Kit Plus
Zeus Scientific EUA for ELISA SARS-CoV-2 IgG Test System
UCLA EUA for SwabSeq COVID-19 Diagnostic Platform
BioFire Diagnostics EUA for BioFire Respiratory Panel 2.1-EZ
Quidel EUA for Sofia 2 Flu + SARS Antigen FIA
Becton Dickinson 510(k) clearance for BD FACSLyric Flow Cytometer with integrated BD FACSDuet Sample Preparation System
LabCorp EUA for RNA extraction method for SARS-CoV-2 testing
Genetron Breakthrough Device Designation for HCCscreen, blood-based NGS test for early detection of liver cancers
Chembio Diagnostics Premarket approval for DPP HIV-Syphilis System
DiaSorin EUA for Liaison SARS-CoV-2 IgM Assay
DiaSorin Approval for six hepatitis B serology assays
Tempus EUA for iC SARS-CoV-2 test
Alimetrix EUA for SARS-CoV-2 RT-PCR Assay
NanoEntek America EUA for Frend COVID-19 total Ab test
Nirmidas Biotech EUA for Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
Centogene EUA for CentoSure-SARS-CoV-2 RT-PCR Assay

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

NEW CE MARKINGS IN EUROPE

Manufacturer(s) Product(s)
Ortho Clinical Diagnostics Vitros SARS-CoV-2 Antigen test
DiaSorin Liaison SARS-CoV-2 Ag chemiluminescence immunoassay
PerkinElmer PKamp Respiratory SARS-CoV-2 RT-PCR Panel for detecting and differentiating SARS-CoV-2, influenza A/B viruses, and RSV
Kantaro Biosciences COVID-SeroKlir and COVID-SeroIndex quantitative SARS-CoV-2 IgG antibody test kits
Becton Dickinson and CerTest Biotec Viasure SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit run on BD Max system
Becton Dickinson Clearance for BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes expanded to cover use to identify and enumerate T-cell subtypes in COVID-19 patients
Specific Diagnostics Reveal, a rapid antimicrobial susceptibility testing system
Siemens Healthineers Clinitest Rapid COVID-19 Antigen Test
Thermo Fisher Scientific EliA SARS-CoV-2-Sp1 IgG test and OmniPath COVID-19 Total Antibody ELISA Test
Oxford Nanopore Technologies LamPore SARS-CoV-2 sequencing test
Omixon AzureSeq-200 RT-PCR kit, an extraction-free viral RNA detection kit to detect SARS-CoV-2

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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