Infectious Disease Care
CUUR DIAGNOSTICS
Emergency Use Authorization (EUA)
CUUR Diagnostics
Topic: Emergency Use Authorization (EUA)
Food and Drug Administration (FDA) Granted Emergency Use Authorization (EUA) to CUUR Diagnostics

As seen on Genomeweb: NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Cuur Diagnostics’ SARS-CoV-2 Molecular Assay.

The RT-PCR-based assay is designed to detect the virus’ N, ORF1ab, and S genes in upper respiratory specimens. It is a version of Thermo Fisher Scientific’s authorized TaqPath COVID-19 Combo Kit that has been modified to run on Thermo Fisher’s Applied Biosystems QuantStudio 12K Flex instrument instead of the Applied Biosystems 7500 Fast Dx instrument and to use a 384-well plate format rather than a 96-well plate format. Nucleic acid extraction is performed using the Thermo Fisher’s KingFisher Flex system with the MagMax Viral/Pathogen Nucleic Acid Isolation Kit.

According to the FDA:

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

According to the CDC:

Formerly, U.S. diagnostic testing for 2019-nCoV was only conducted at CDC. However, with the EUA determination and the pursuant distribution of the tests, 2019-nCoV diagnostic testing can take place at laboratories designated by CDC. These U.S. labs are qualified and certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity tests. These labs include 115 U.S. state and local public health laboratories and Department of Defense (DoD) laboratories. CDC 2019-nCoV RT-PCR Diagnostic Panel will not be available in U.S. hospitals or primary care settings.

CUUR Diagnostics Laboratories

CUUR Diagnostics laboratories offer molecular qPCR diagnostic testing and utilizes industry leading equipment including the latest technologies from ThermoFisher and operates under the Emergency Use Authorization (EUA) guidance issued by the FDA and CAP and CLIA quality standards.

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FULL LIST of CUUR INFECTIOUS DISEASE PANELS

  • Respiratory w/COVID-19 Panels
  • UTI Panels
  • STI Panels
  • Gastrointestinal Panel
  • Vaginal Microbiota Panel
  • Skin & Wound Panel
  • Nail Panel
  • Antimicrobial Resistance Panel
  • Custom Panels
Infectious Disease Care
Learn More Important Information About CUUR Diagnostics by Visiting Our Main Site.

CUUR Diagnostics was founded by experienced medical scientists and healthcare professionals and utilize industry leading equipment including Thermofisher, under CAP and CLIA quality standards, to rapidly deliver high complexity qPCR molecular testing for infectious disease identification. The CUUR Diagnostics’ SARS-COV-2 assay is an Emergency Use Authorization (EUA) test awarded by the U.S. FDA.

CUUR Diagnostics is a division of Assurity Healthcare, a Medicare-certified clinical laboratory provider that offers innovative healthcare laboratory solutions to hospitals, clinics and other medical entities. Serving clients across multiple states in the U.S., our services include infectious disease testing, planning, build-out, staffing, compliance and operation of complex medical labs.

CUUR Panels:
Respiratory w/COVID-19, UTI, Skin & Wound, Vaginal Microbiota, Nail, STI, Gastrointestinal, Antimicrobial Resistance, and Custom Panels

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