LabPulse.com staff writers

Emerging Technology
Week in Review: Rising genomics wave | Rapid stroke diagnosis | Lab leader survey
February 8, 2025
Research Grant
AstraDx receives $30M CARB-X funding for neonatal sepsis test
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has awarded $3 million to diagnostics company AstraDx to develop a rapid test for neonatal sepsis.
February 7, 2025
Sepsis Bacteria Social
Sequencing
Helix launches genomic dataset of GLP-1 agonist-treated patients
Genetic testing and population genomics firm Helix announced the launch of a research-ready clinico-genomic dataset of over 15,000 patients treated with glucagon-like-peptide-1 (GLP-1) agonists.
February 7, 2025
Dna Data Ai Social
Mergers & Acquisitions
BD to separate biosciences and diagnostics business from company
Becton Dickinson (BD) announced that its board of directors has unanimously authorized a plan to separate its biosciences and diagnostic solutions business from the rest of the company.
February 6, 2025
Business Intelligence Social
Molecular Diagnostics
ABL, Siemens Healthineers sign licensing agreement
Advanced Biological Laboratories (ABL) and Siemens Healthineers have signed a licensing and transfer agreement of know-how and intellectual property rights from Fast Track Diagnostics Luxembourg to ABL.
February 6, 2025
Test Tube Liquid Sample Social
Regulatory Approval
AliveDx gets CE Mark for multiplex autoimmune test
AliveDx has received the CE Mark for its multiplex assay for the diagnosis of systemic autoimmune rheumatic diseases.
February 5, 2025
Blood Test Samples Lab Social
Diagnostic Technologies
Study findings presented on early stroke-type detection test
A new blood test may rapidly distinguish stroke type before people with stroke symptoms reach the emergency department, according to a preliminary study being presented at the American Stroke Association's International Stroke Conference 2025.
February 5, 2025
Blood+sample+in+lab Social
Diagnostic Technologies
U.K. lab leader survey brings 3 key issues to front
Study shows goals for staff retention, upskilling lab teams, and narrowing STEM gap.
February 5, 2025
Online Survey
FDA Clearance
Vertex non-opioid analgesic gets FDA approval
The U.S. Food and Drug Administration (FDA) has approved Vertex’s Journavx, the first analgesic to be approved in a novel class of non-opioid pain medications indicated for moderate to severe acute pain relief.
February 4, 2025
Fda Sign Dc Social
Lawsuit
PTAB rules 10x Genomics patent claims invalid in Parse suit
The Patent Trial and Appeal Board (PTAB) has invalidated all claims of patent infringement in 10x Genomics' lawsuit against Parse Biosciences.
February 4, 2025
Law Books Gavel Social
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Top Stories
Judge Gavel Court 67927db09fe68
Lawsuit
Legal team highlights cautionary clinical laboratory fraud case
Clinical laboratory litigation indicates growing trend of cases filed by nontraditional whistleblowers.
Dna Sequencing Social
Emerging Technology
What's coming in clinical genomics?
Scientist Atom Molecule
Policy and Regulation
Lab leaders advised to maintain communication with regulatory agencies during blackout
Judge Gavel Court
Lawsuit
Federal judge dismisses pathology group antitrust case
Body composition in patients treated with Ozempic
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Body composition in patients treated with Ozempic
More in Home
Legal team highlights cautionary clinical laboratory fraud case
By LabPulse.com staff writers
Clinical laboratory litigation indicates growing trend of cases filed by nontraditional whistleblowers.
January 29, 2025
Judge Gavel Court 67927db09fe68
What's coming in clinical genomics?
By Liz Carey
Clinicians, geneticists, and pathologists face a bioinformatic bottleneck.
January 30, 2025
Dna Sequencing Social
Lab leaders advised to maintain communication with regulatory agencies during blackout
By LabPulse.com staff writers
Attorneys serving the clinical laboratory community said to expect regulatory agency communications in the U.S. to resume on or around February 1, but providers can maintain a record of their communications with them in the meantime.
January 24, 2025
Scientist Atom Molecule
Federal judge dismisses pathology group antitrust case
By LabPulse.com staff writers
A federal judge has dismissed an antitrust lawsuit filed last year pitting pathology groups Iowa Pathology Associates, Regional Laboratory Consultants, and Goldfinch Laboratory against one another.
January 23, 2025
Judge Gavel Court
CAP prioritizes pathologists' needs in 2025
By Liz Carey
In a letter to the Trump administration and 119th Congress, the College of American Pathologists (CAP) prioritized the top regulatory, payer, and workforce issues facing anatomic pathologists and their teams in 2025.
January 22, 2025
Washington Dc Capitol (2)
$16.5B CDMO deal unhindered by role in broader pharma supply chain
By Liz Carey
Novo Holdings greenlighted by European Commission to take control of U.S.-based CDMO.
December 11, 2024
Business Graph Money Stocks Social (1)
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
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
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
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