Infectious

FDA 510(k), CLIA waiver may boost Roche STI tests
By LabPulse.com staff writers
Roche has been granted 510(k) clearance with a CLIA waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels.
January 22, 2025
Roche Brand Media Library Image 2024 Social
IntelliGenome accelerates CRISPR-PCR TB testing studies
By LabPulse.com staff writers
IntelliGenome's CRISPR-Tuberculosis (TB) Blood Test has received the breakthrough device designation from the U.S. Food and Drug Administration.
January 21, 2025
Blood Test Samples Lab (2)
FDA clears Inflammatix rapid sepsis test system
By LabPulse.com staff writers
Sunnyvale, CA-based Inflammatix has received marketing authorization from the U.S. Food and Drug Administration (FDA) for its TriVerity rapid sepsis test system
January 21, 2025
Bacteria Blood Sepsis Social 67576a5b0e9e8
Study targets hospital blood culture use toward stewardship
By Liz Carey
Individual hospitals should track both blood culture use and positivity rates over time and establish benchmarks to improve blood culture stewardship, suggests a study published recently in JAMA Network Open.
January 16, 2025
Culture Sample Social
NIST develops genetic material for validating H5N1 diagnostic tests
By LabPulse.com staff writers
The National Institute of Standards and Technology (NIST) has developed a nonhazardous synthetic genetic material designed to validate diagnostic tests for the H5N1 virus, commonly known as bird flu.
January 3, 2025
Avian Influenza A Virus Social
Health Canada grants approval for MedMira's HIV and syphilis test
By LabPulse.com staff writers
Regulatory body Health Canada has granted approval to MedMira's point-of-care test for HIV and syphilis.
December 27, 2024
Syphilis Treponema Bacteria Social
Labcorp launches H5N1 avian flu test in the U.S.
By LabPulse.com staff writers
Labcorp has launched its new molecular diagnostic test for patients suspected of infection with the H5N1 virus responsible for the current outbreak of H5 avian flu.
December 19, 2024
Avian Influenza A Virus Social
FDA grants breakthrough device designation to MeMed sepsis test
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to MeMed for its rapid diagnostic and risk assessment test for sepsis.
December 12, 2024
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BioMĂ©rieux's Biofire tropical fever panel gets special 510(k) clearance
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted special 510(k) clearance to BioMĂ©rieux's syndromic tropical fever panel, developed in conjunction with U.S. government agencies.
December 9, 2024
Infectious Diseases Research Social
Nationwide claims analysis questions value of multiplex molecular panels for UTI
By Liz Carey
Reimbursement for molecular syndromic panel testing for UTI may continue to face uncertainty.
December 10, 2024
2020 07 07 Clostridioides Difficile Cdc Social
T2 Biosystems to license pathogen-detection technology
By LabPulse.com staff writers
T2 Biosystems plans to license its proprietary technology for the detection of sepsis-causing pathogens from whole blood.
December 9, 2024
Bacteria Blood Sepsis Social
WHO grants 1st prequalification to Cepheid TB test
By LabPulse.com staff writers
The World Health Organization (WHO) has granted prequalification to Cepheid’s molecular diagnostic tuberculosis (TB) test.
December 6, 2024
Bacteria Mycobacterium Tuberculosis Social
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