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FDA said no to proficiency testing for LDT quality
By
Liz Carey
Inferior tests can pass through proficiency testing, among ways PT falls short for test safety and effectiveness for intended purposes.
May 2, 2024
Cue Health to cut 230 jobs in restructuring plan
By
LabPulse.com staff writers
In a filing with the U.S. Securities and Exchange Commission, Cue Health said it intends to cut 230 jobs, 49% of its workforce, as part of a cost-reduction plan the firm is implementing.
May 3, 2024
Leica Biosystems, Sectra receive FDA 510(k) clearance for digital pathology system
By
LabPulse.com staff writers
Leica Biosystems has received 510(k) clearance from the U.S Food and Drug Administration (FDA) for its Aperio GT 450 DX digital pathology system, in conjunction with Sectra's digital pathology software.
May 2, 2024
Quest Diagnostics to add digital pathology lab, AI pathology center in Tennessee
By
LabPulse.com staff writers
Quest Diagnostics said it will acquire PathAI Diagnostics in Memphis, TN, the business of PathAI that provides anatomic and digital pathology laboratory services, to accelerate the adoption of digital and AI pathology.
May 1, 2024
FDA releases LDT final rule
By
Liz Carey
The FDA announced its final rule on regulating laboratory developed tests (LDTs), also saying it will adopt targeted enforcement discretion for several categories of IVD LDTs manufactured by labs.
April 29, 2024
Variantyx raises $36M in funding
By
LabPulse.com staff writers
Precision molecular diagnostics firm Variantyx has raised $36 million in a recent funding round, bringing the total funding that Variantyx has raised to more than $125 million.
April 30, 2024
Pillar Biosciences gets FDA approval for NGS solid tumor profiling test
By
Matt Limb
Pillar Biosciences has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its OncoReveal CDx pan-cancer next-generation sequencing (NGS) test for general solid tumor profiling.
April 26, 2024
Vertex to pay $25M upfront to scale cell manufacturing technology
By
LabPulse.com staff writers
As part of the deal, Vertex was also willing to pay up to $215 million in milestones achieved in connection with the development of a scaled-up process for fully differentiated islet cells.
April 25, 2024
Labcorp buys Invitae portfolio for $239M
By
LabPulse.com staff writers
Labcorp was the winning bidder in the court-supervised auction of Invitae's assets, obtaining substantially all of the San Francisco-based company's business for $239 million in cash consideration with other noncash consideration.
April 26, 2024
Bristol Myers Squibb to reduce workforce in restructuring plan
By
LabPulse.com staff writers
As part of a restructuring plan intended to cut $1.5 billion in costs, Bristol Myers Squibb plans to cut about 6% of its workforce, according to the firm.
April 25, 2024
U.K. Patents Court rules Bio-Techne patents invalid in infringement lawsuit
By
LabPulse.com staff writers
The Patents Court of the High Court of England and Wales has ruled that two patents owned by Bio-Techne are invalid, rejecting a patent infringement lawsuit filed by Bio-Techne/ACD in the U.K. against Molecular Instruments.
April 24, 2024
Bio-Techne files EU patent infringement suit against Molecular Instruments
By
LabPulse.com staff writers
Life sciences company Bio-Techne has filed a lawsuit against Molecular Instruments in the pan-European Unified Patent Court, alleging patent infringement of its RNAscope in situ hybridization technology.
April 23, 2024
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