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Business Insights: Page 2
Geneoscopy receives FDA approval for CRC screening test
By
LabPulse.com staff writers
Geneoscopy announced that the U.S. Food and Drug Administration (FDA) has approved ColoSense, the firm's noninvasive multitarget stool RNA colorectal cancer (CRC) screening test.
May 7, 2024
German court rules patent invalid in 10x infringement suit against NanoString
By
LabPulse.com staff writers
The German Federal Patent Court has ruled invalid the German part of a patent at the heart of a lawsuit brought by 10x Genomics against NanoString Technologies, now a Bruker subsidiary.
May 8, 2024
Karius raises $100M in series C funding
By
LabPulse.com staff writers
Diagnostics firm Karius has secured $100 million in series C funding in a recent financing round.
May 6, 2024
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
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