Molecular Diagnostics

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
Helix opens genomics to 3 health systems, plugs into Komodo Healthcare Map
By LabPulse.com staff writers
Companies learning from clinical laboratory, pharmacy, and mortality data.
January 15, 2025
Dna Sequence Shadow Social
Mayo Clinic Laboratories, Lucence partner to expand access to liquid biopsy
By LabPulse.com staff writers
Mayo Clinic Laboratories and Lucence have announced a strategic collaboration to expand international access to Lucence's liquid biopsy technology.
January 13, 2025
Lab Test Tube Dna Blood Social
Oxford University team develops early-detection multicancer test
By LabPulse.com staff writers
Oxford University researchers have developed a promising liquid biopsy test that uses machine learning to detect six forms of cancer in their earliest stages.
January 9, 2025
Cancer Cell Microenvironment Social
FDA issues draft guidance for IVDs for emerging pathogens
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has released a draft guidance giving recommendations for validating in vitro diagnostic devices (IVDs) for emerging pathogens during a declared emergency.
January 8, 2025
Fda Sign Dc Social
Myriad expands scope of whole genome sequencing-based MRD projects
By LabPulse.com staff writers
The goal of the studies is to generate evidence that supports national guideline inclusion and healthcare provider adoption.
January 7, 2025
Dna Cancer Cell 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
U.S. and Europe grapple with medical device, IVD regulation decisions
By Liz Carey
Clinical and research laboratory community and medical device manufacturers await decisions in first quarter 2025.
January 2, 2025
Regulation Wheel Social
Geisinger receives $175K AWS Imagine grant for genomics data platform
By LabPulse.com staff writers
Health network Geisinger has received a $175,000 Amazon Web Services (AWS) Imagine grant to accelerate the development of a new genomics data platform.
December 30, 2024
Money Bag Grant Award Social
Quest to provide services for Mainz Biomed CRC test clinical trials
By LabPulse.com staff writers
Mainz Biomed has made an agreement with Quest Diagnostics in which Quest will support the commercialization of Mainz Biomed’s next-generation ColoAlert colorectal cancer (CRC) screening test.
December 19, 2024
Colorectal Cancer Social
Ovation.io, Illumina collaborate on genomics research data
By LabPulse.com staff writers
Genomic data firm Ovation.io has entered into a collaboration with Illumina to provide researchers with a genomics dataset for indications outside of oncology.
December 18, 2024
Science Genome Sequence Dna Map 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
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