LabPulse.com staff writers

Trends and Finance
Week in Review: Kronos Bio layoffs | Marburg virus test BARDA award | Google health AI platform release
December 7, 2024
Trends and Finance
Amgen to open second N.C. manufacturing facility
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.
December 6, 2024
Manufacturing Facility Process Social
Regulatory Approval
WHO grants 1st prequalification to Cepheid TB test
The World Health Organization (WHO) has granted prequalification to Cepheid’s molecular diagnostic tuberculosis (TB) test.
December 6, 2024
Bacteria Mycobacterium Tuberculosis Social
Gene expression
VA to offer no-cost pharmacogenomic testing program
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.
December 5, 2024
Blood Test Samples Lab Social
Sequencing
GeneDx expands exome testing program for pediatric epilepsy patients
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
Regulatory Approval
FDA grants breakthrough device designation to DeepUll's bloodstream infection test
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
Validation
Oncocyte releases data on transplant rejection assay
Diagnostics developer Oncocyte has announced study data showing that its monitoring assay for kidney transplant rejection significantly reduces the time to diagnosis.
December 4, 2024
Kidneys Closeup Social
Collaboration
Gilead, Tubulis to collaborate on ADC program
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
Collaboration
COUR Pharmaceuticals, Genentech sign agreement on autoimmune therapeutics development
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
Regulatory Approval
Devyser gets IVDR approval for fetal RHD test
Devyser Diagnostics has received In Vitro Diagnostic Regulation (IVDR) certification for its noninvasive fetal rhesus D (RHD) screening test.
December 2, 2024
Patient Woman Pregnant Social
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Handcuffs Gavel Social
Business Insights
Texas lab owner accused of $79M RPP fraud scheme
The DOJ implicated a Texas clinical laboratory owner and operator in respiratory pathogen panel testing fraud scheme.
Baby Infant Mom Closeup Social
Research and Development
Revvity broadens work in newborn testing for NHS England
Ovarian Cancer2 Social
Regulatory Approval
Roche gets CE Mark for ovarian cancer CDx test
Covid Treatment Doctor Social
Sequencing
AMP reviews pitfalls of NGS testing for SARS-CoV-2
Body composition in patients treated with Ozempic
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Body composition in patients treated with Ozempic
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Texas lab owner accused of $79M RPP fraud scheme
By LabPulse.com staff writers
The DOJ implicated a Texas clinical laboratory owner and operator in respiratory pathogen panel testing fraud scheme.
November 25, 2024
Handcuffs Gavel Social
Revvity broadens work in newborn testing for NHS England
By LabPulse.com staff writers
Revvity, formerly PerkinElmer, will expand its work with Genomics England to continue the Generation Project.
November 20, 2024
Baby Infant Mom Closeup Social
Roche gets CE Mark for ovarian cancer CDx test
By LabPulse.com staff writers
Roche has received the CE Mark under the European Union's In Vitro Diagnostic Regulation for its companion diagnostic (CDx) test, which is designed to aid in identifying ovarian cancer patients eligible for targeted treatment with Abbvie's Elahere.
November 19, 2024
Ovarian Cancer2 Social
AMP reviews pitfalls of NGS testing for SARS-CoV-2
By Liz Carey
Document offers key pre-analytical, analytical, and post-analytical considerations to help improve NGS-based surveillance programs.
November 15, 2024
Covid Treatment Doctor Social
FDA fall IVD roundtable avoids LDT questions
By Liz Carey
In addition, CAP LDT webinar offers beginning guide for phase one compliance.
November 12, 2024
Diagnostic Analyzer Lab Pcr Social
Lucy Letby murder case flags immunoassays as unreliable for medical evidence
By Liz Carey
At least one pathologist has said it was wrong for scientists representing Liverpool Clinical Laboratories to insist insulin poisoning was the only explanation in a series of high-profile newborn deaths in the U.K., The Telegraph reported.
October 28, 2024
Gavel Handcuffs Proxima Studio
Digital pathology rollouts race for proof-of-concept at national level
By Liz Carey
U.K. invests in clinical trial security while Australia's health minister issues powerful ultimatum.
October 29, 2024
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Caris Life Sciences embarks on 10K-sample breast cancer biomarker analysis project
By LabPulse.com staff writers
Caris will perform comprehensive molecular characterization of TAILORx tissue samples.
October 25, 2024
Dna Sequence (1)
ASCLS seeks support for med lab personnel act
By LabPulse.com staff writers
The proposed legislation includes loan repayment provisions and requires $25 million in the first year.
October 25, 2024
Washington Dc Capitol
Pathology groups' antitrust legal fight heats up
By LabPulse.com staff writers
A lawsuit in which Iowa pathologists are suing their former colleagues is escalating, with one side accusing the other of attempting to maintain a monopoly at the expense of patients.
October 24, 2024
Lawsuit Social
Mobile lab, owners to pay $135K to settle Medicare fraud case
By LabPulse.com staff writers
A California mobile phlebotomy operation and its owners will collectively pay $135,000 to resolve alleged fraud and Anti-Kickback Statute violations.
October 23, 2024
Gavel Money Social
Payer consolidation raises red flags for diagnostic testing, pathology leaders
By Liz Carey
A new report from the U.S. Department of Health and Human Services Office of the Inspector General shows that Medicare administrative contractors do not always comply with Medicare payment policies.
October 23, 2024
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