Diseases

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
FDA grants breakthrough device designation to DeepUll's bloodstream infection test
By LabPulse.com staff writers
Diagnostics developer DeepUll has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its rapid bloodstream infection test.
December 4, 2024
Sepsis Bacteria Social
GeneDx expands exome testing program for pediatric epilepsy patients
By LabPulse.com staff writers
GeneDx has expanded its patient access program for pediatric epilepsy, which provides access to whole exome sequencing to qualifying pediatric patients.
December 5, 2024
Dna Sequencing Data Analysis Social
Gilead, Tubulis to collaborate on ADC program
By LabPulse.com staff writers
Gilead and biotech firm Tubulis have forged an exclusive option and license agreement to discover and develop an antibody-drug conjugate (ADC) against an undisclosed solid tumor target.
December 3, 2024
Cancer Cell Microenvironment Social
COUR Pharmaceuticals, Genentech sign agreement on autoimmune therapeutics development
By LabPulse.com staff writers
Clinical-stage biotech firm COUR Pharmaceuticals announced a strategic partnership and licensing agreement with Genentech for the development and commercialization of COUR's nanoparticle treatments for an undisclosed autoimmune disorder.
December 3, 2024
Business Agreement Social
Jury awards Guardant nearly $293M in lawsuit against Natera
By LabPulse.com staff writers
A federal jury in the U.S. District Court for the Northern District of California ruled in favor of Guardant Health in a lawsuit the company filed against Natera in May 2021.
November 26, 2024
Gavel Money Lawsuit Social
BD, MD Anderson launch pilot program for cervical cancer screening access
By LabPulse.com staff writers
The study will evaluate the effectiveness of self-collected HPV testing in a real-world setting while aiming to identify challenges and solutions for cervical cancer screening in communities with limited healthcare access.
November 22, 2024
Hpv Infection Social
FDA sounds bacteria alarms over CGMP violations in Maine
By Liz Carey
Tom's troubles highlight the importance of being inspection-ready.
November 21, 2024
Fda Logo V2 Social
Lunit adds AstraZeneca for NSCLC biomarker screening AI
By LabPulse.com staff writers
Companies to integrate Scope Genotype Predictor into pathology workflows to screen for actionable mutations in non-small cell lung cancer research.
November 18, 2024
Nsclc Slides
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