LabPulse.com staff writers

Sequencing
Myriad expands scope of whole genome sequencing-based MRD projects
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
Fraud
Labcorp, UHS settle False Claims Act testing allegations
Labcorp and University Health System (UHS) have collectively agreed to pay nearly $389,000 to settle allegations that they violated the False Claims Act by delaying the submission of physician orders for lab tests to improperly bill Medicare.
January 6, 2025
Gavel Money Lawsuit Social
Emerging Technology
Sysmex America, DiaCarta highlight FIT CRC screening tests
Developments that may signal increased fecal immunochemical testing in colorectal cancer screening worldwide in 2025.
January 6, 2025
Colorectal Cancer Social
Emerging Technology
UC Riverside team's nanopore-based sensor shows promise for diagnostics
A research team at the University of California, Riverside (UC Riverside) has developed a nanopore-based sensor that may help diagnose illnesses with greater precision than conventional diagnostics by capturing signals from individual molecules.
January 3, 2025
Molecule Social
Molecular Diagnostics
NIST develops genetic material for validating H5N1 diagnostic tests
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
Collaboration
Versant Diagnostics reports Avero Diagnostics partnership
Versant Diagnostics has expanded its footprint in the Pacific Northwest through partnership affiliation with Avero Diagnostics in Bellingham, WA.
January 2, 2025
Business Handshake Intelligence Social
Funding
Geisinger receives $175K AWS Imagine grant for genomics data platform
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
Lawsuit
BioNTech reaches agreement with NIH, Penn on COVID-19 vaccine royalties
German company BioNTech has entered into two separate settlement agreements with the U.S. National Institutes of Health (NIH) and the University of Pennsylvania (Penn) over royalty payments for its COVID-19 vaccine.
December 27, 2024
Agreement Legal Settlement Social
Regulatory Approval
Health Canada grants approval for MedMira's HIV and syphilis test
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
Financing
GemmaBio raises $34M in seed funding
Newly-formed therapeutics firm Gemma Biotherapeutics (GemmaBio) has completed a $34 million financing round.
December 26, 2024
Research Money Social
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Top Stories
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Mergers & Acquisitions
$16.5B CDMO deal unhindered by role in broader pharma supply chain
Novo Holdings greenlighted by European Commission to take control of U.S.-based CDMO.
Handcuffs Gavel Social
Compliance and Regulation
Texas lab owner accused of $79M RPP fraud scheme
Fda Logo V2 Social
FDA Warning Letter
FDA sounds bacteria alarms over CGMP violations in Maine
Baby Infant Mom Closeup Social
Research and Development
Revvity broadens work in newborn testing for NHS England
Body composition in patients treated with Ozempic
Sponsor Content
Body composition in patients treated with Ozempic
More in Home
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
Denied Form Sign
New York State OKs NeoGenomics' pancancer solid tumor, targeted lung NGS tests
By LabPulse.com staff writers
The New York State Department of Health has granted conditional approval for two NeoGenomics' next-generation sequencing (NGS) tests.
October 22, 2024
Lab Blood Dna
CLIAC to address remote competency assessments
By Liz Carey
The next Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting will address transitioning to remote competency assessments of medical laboratory personnel.
October 21, 2024
Remote Competency Assessments Lab Thumbnail
FDA warns against use of Cue Health’s COVID-19 tests due to risk of false results
By LabPulse.com staff writers
Approximately 248,109 kits were distributed nationwide in the U.S.
October 17, 2024
Fda Logo V2 Social
GSK files mRNA technology patent lawsuits against Moderna
By LabPulse.com staff writers
GSK filed two lawsuits against Moderna claiming that Moderna infringed on GSK's patent rights in its mRNA COVID-19 and RSV vaccines.
October 17, 2024
Lawsuit Social
Swiss team develops new allergy testing approach
By LabPulse.com staff writers
A team of researchers at the University of Bern and Bern University Hospital in Switzerland have developed a test that shows promise for improving the diagnosis of food allergies.
October 16, 2024
Test Tubes Social
BD launches robotics-compatible reagent kits for single-cell research
By LabPulse.com staff writers
Becton, Dickinson and Company (BD) announced the commercial launch of a new line of high-throughput, robotics-compatible reagent kits designed for automation to ensure consistency and efficiency in single-cell research.
October 15, 2024
Single Cell Analysis Social
Magellan Diagnostics sentenced for concealing lead-testing device malfunction
By LabPulse.com staff writers
Magellan Diagnostics was sentenced in federal court for criminal charges related to concealing a device malfunction that caused inaccurately low lead test results for tens of thousands of children and other patients.
October 14, 2024
Gavel Money Lawsuit Social
FDA approves Genentech's breast cancer therapy, Foundation Medicine's CDx
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) approved the FoundationOne Liquid test as a companion diagnostic (CDx) with Genentech's Itovebi combination therapy for certain patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
October 14, 2024
Fda Sign Dc Social
Myriad Genetics enters 5 MRD test research collaborations
By LabPulse.com staff writers
Precision medicine company Myriad Genetics has entered into five ongoing research collaborations aimed at studying the use of molecular residual disease (MRD) testing in breast cancer using Myriad's Precise MRD test.
October 9, 2024
Breast Cancer2 Social
Proscia launches pathology AI model toolkit
By Liz Carey
Proscia has launched Concentriq Embeddings for experimenting with multiple pathology artificial intelligence (AI) models in parallel.
October 2, 2024
Proscia Embeddings
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