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Revvity broadens work in newborn testing for NHS England
November 20, 2024
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Roche gets CE Mark for ovarian cancer CDx test
November 19, 2024
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September 20, 2024
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FDA fall IVD roundtable avoids LDT questions
November 12, 2024
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WHO grants 1st prequalification to Cepheid TB test
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Amgen to open second N.C. manufacturing facility
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FDA grants breakthrough device designation to DeepUll's bloodstream infection test
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COUR Pharmaceuticals, Genentech sign agreement on autoimmune therapeutics development
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VA to offer no-cost pharmacogenomic testing program
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GeneDx expands exome testing program for pediatric epilepsy patients
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Oncocyte releases data on transplant rejection assay
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Devyser gets IVDR approval for fetal RHD test
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FDA grants breakthrough device designation to DeepUll's bloodstream infection test
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GeneDx expands exome testing program for pediatric epilepsy patients
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Gilead, Tubulis to collaborate on ADC program
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COUR Pharmaceuticals, Genentech sign agreement on autoimmune therapeutics development
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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.
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Amgen to open second N.C. manufacturing facility
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Biotech firm and drug manufacturer Amgen has announced a $1 billion expansion in North Carolina, with plans to establish a second manufacturing facility in the state.
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VA to offer no-cost pharmacogenomic testing program
By LabPulse.com staff writers
The U.S. Department of Veterans Affairs (VA) is offering no-cost pharmacogenomic testing to veterans enrolled at Veterans Integrated Service Network 4 facilities through the end of 2025.
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FDA grants breakthrough device designation to DeepUll's bloodstream infection test
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Diagnostics developer DeepUll has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its rapid bloodstream infection test.
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GeneDx expands exome testing program for pediatric epilepsy patients
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GeneDx has expanded its patient access program for pediatric epilepsy, which provides access to whole exome sequencing to qualifying pediatric patients.
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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.
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Oncocyte releases data on transplant rejection assay
By LabPulse.com staff writers
Diagnostics developer Oncocyte has announced study data showing that its monitoring assay for kidney transplant rejection significantly reduces the time to diagnosis.
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COUR Pharmaceuticals, Genentech sign agreement on autoimmune therapeutics development
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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.
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Devyser gets IVDR approval for fetal RHD test
By LabPulse.com staff writers
Devyser Diagnostics has received In Vitro Diagnostic Regulation (IVDR) certification for its noninvasive fetal rhesus D (RHD) screening test.
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OraSure awarded BARDA contract for Marburg virus disease test
By LabPulse.com staff writers
OraSure Technologies was awarded federal funding for the development of a Marburg virus disease rapid antigen test.
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Kronos Bio announces layoffs, CEO transition
By LabPulse.com staff writers
Kronos Bio will lay off approximately 83% of its workforce as part of a previously announced cost-reduction strategy.
December 2, 2024
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Oxford Nanopore, UK Biobank to collaborate on epigenetic dataset
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Oxford Nanopore and the UK Biobank are collaborating on an initiative to create a comprehensive, large-scale epigenetic dataset, with the aim of gaining critical insights into the mechanisms of common diseases.
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