FDA Watch: Two More Zika Tests Get Emergency Use Authorization

Zika made the FDA headlines this month, with two more tests receiving emergency use authorization:

  • Thermo Fisher Scientific’s TaqPath Zika Virus Kit for the qualitative detection of Zika virus RNA in human serum and urine; and
  • Columbia University’s Mailman School of Public Health’s CII-ArboViroPlex rRT-PCR test for simultaneous detection of the Zika virus and other similar Flaviviruses.

FDA Steps Up on Serological Zika Testing

In August, the FDA also announced that it’s offering a panel of human plasma samples to assist in its evaluation of serological tests detecting recent Zika virus infection. The panel contains plasma samples from individuals infected with Zika, West Nile or dengue viruses. While the panel is not for research purposes, developers can take use them to determine whether their tests can help identify recent Zika virus infection from fellow viruses.

Currently, there are two

 primary blood diagnostic tests for Zika: nucleic acid tests that detect infection by confirming presence of a virus’ RNA, and serological tests that identify antibodies that the body’s immune system produces when it senses harmful organisms like Zika in the blood. Serological tests are crucial given the small window when the virus’ genetic material is noticeable in the bloodstream.

Here’s a look at key FDA diagnostics approvals in late July through mid-August:


Manufacturer(s) Product(s)

Roche Diagnostics

Approval of Cobas b 101 instrument that uses a single-use reagent disc to measure HbA1c from capillary and venous whole-blood samples
Roche Diagnostics Approval of Cobas HbA1c test for quantitative measurement of glycate hemoglobin
Thermo Fisher Scientific Emergency use authorization of TaqPath Zika Virus Kit for qualitative detection of RNA from Zika virus and diagnosis of Zika virus infection in human serum and urine collected alongside patient-matched serum specimen
Columbia University’s Mailman School of Public Health Emergency use authorization of CII-ArboViroPlex rRT-PCR test for simultaneous detection of Zika virus and similar Flaviviruses
iCubate Approval of iC-System and iC-GPC assay for rapid detection of pathogenic bacteria associated with bloodstream infections—first iCubate product cleared by FDA
ImpediMed Approval of Sozo bioimpedance spectroscopy platform which uses the ImpediMed  L-Dex lateral lymphedema assessment system for measuring and monitoring fluid status and body composition
Abbott Laboratories Approval of RealTime IDH2 Assay, a companion diagnostic run on Abbott’s m2000 RealTime PCR instrument, for identifying acute myeloid leukemia patients  with IDH2 gene mutations that may  benefit from new Celgene therapy called Idhifa
Bruker Expanded approval of MALDI Biotyper system to include third version that adds 144 microbial species to database of anaerobes, gram-positive and gram-negative bacteria, and yeasts
BioMérieux Expanded approval of Vitek MS MALDI-TOF Mass Spectrometry System for rapid pathogen identification to include identification of mycobacteria, Nocardia and molds
Becton Dickinson Approval of BD FACSLyric flow cytometer system
Immco Diagnostics Approval of ELISA test for celiac disease performed as a solid phase immunoassay
Luminex Approval of Aries C. difficile assay for rapid detection of Clostridium difficile
Shenzhen New Industries Biomedical Approval of Maglumi 2000 automated immunoassay analyzer for running IVD tests on clinical serum samples
Shenzhen New Industries Biomedical Approval of Maglumi 2000 TSH assay for identifying thyroid disorder via quantitative analysis of thyroid-stimulating hormone in human serum

In addition, DxNA announced that it has applied for 510(k) clearance of GeneSTAT, its real-time PCR system and test for Valley Fever.

New CE Marks & Global Certifications

Here’s a summary of notable European CE certifications:

Manufacturer(s) Product(s)

Thermo Fisher Scientific

Approval of QuantStudio 5 Dx Real-Time PCR system
Biomatrica Approval of RNAgard Blood for preserving total nucleic acids in blood for evaluating gene expression and methylation biomarkers
Biomatrica Approval of SalivaGard HT DNA sample collection tube to provide DNA yield for carrier screening, oncology and other NGS applications
Biomatrica Approval of LBgard Blood sample collection tube for preserving cfDNA for liquid biopsy and noninvasive prenatal testing;.
T2 Biosystems Approval of T2Bacteria Panel which will be sold as part of T2Sepsis Solution in Europe in 3Q of 2017

On July 21, OraSure Technololgies announced that it had secured World Health Organization backing for its OraQuick HIV-Self Test for detecting HIV with an oral swab in 20 minutes.


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