Business Insights: Page 12

C2N, Unilabs sign global agreement on early Alzheimer's diagnostics
By LabPulse.com staff writers
C2N and Unilabs have signed a multiyear agreement that will increase access to C2N's Precivity blood tests for the early diagnosis of Alzheimer's disease to Unilabs' testing network on an exclusive basis.
August 8, 2024
Alzheimers Phases Amyloid Social
TCET reinforces MAC, MolDx reviews of IVD products, diagnostic laboratory tests
By Liz Carey
Anticipated result of new coverage pathway would be faster access to technologies within a predictable coverage framework that generates clinical evidence for the Medicare population.
August 8, 2024
Research Money Social
Thermo Fisher gets FDA 510(k) clearance for HLA typing CDx
By LabPulse.com staff writers
Thermo Fisher's SeCore CDx HLA A Sequencing System has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use as a companion diagnostic (CDx) with Adaptimmune's T-cell receptor therapy Tecelra for synovial sarcoma.
August 7, 2024
Fda Sign Dc Social
Cepheid lays off over 600 employees in Calif.
By LabPulse.com staff writers
Molecular diagnostics firm Cepheid is laying off 626 employees at its Sunnyvale, CA, headquarters and 11 employees at its Fremont, CA, logistics center, according to a Worker Adjustment and Retraining Notification filed with the state of California.
August 7, 2024
Layoff Form Sign Social
Inpeco introduces FlexLabX total lab automation at ADLM 2024
By LabPulse.com staff writers
Company highlighted system's graphical user interfaces, data analytics functionality, and full sample traceability.
August 2, 2024
Inpeco Flex Lab X Input Output Module
Labcorp gets FDA de novo authorization for solid tumor mutation liquid biopsy test
By LabPulse.com staff writers
Labcorp has received de novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its PGDx Elio Plasma Focus Dx kitted assay, a pan-solid tumor liquid biopsy test that enables tumor mutation profiling.
August 5, 2024
Fda Button Social
Paige releases open-source million-slide foundation model suite
By LabPulse.com staff writers
Company anticipates the development of clinical-grade products for less-common cancers.
August 1, 2024
Pathology Digital Workstation Microscope Social
New laboratory developed tests for colorectal cancer screening get boost from CMS
By Liz Carey
Clinical laboratory test manufacturers aim for estimated 60 million unscreened Americans as CMS meets them with a broad CRC screening test definition and proposed coverage changes in 2025.
July 31, 2024
Colorectal Cancer Social
ADLM 2024: Effects of FDA's final rule on LDTs discussed in special session
By LabPulse.com staff writers
The effects of the U.S. Food and Drug Administration's (FDA) final rule on laboratory-developed tests (LDTs) were the topic of a special session held on June 30 at the Association for Diagnostics & Laboratory Medicine (ADLM) annual meeting in Chicago.
August 2, 2024
Lab Tubes Pipette Social
BURL Concepts, Bracco partner on ischemic stroke detection
By LabPulse.com staff writers
San Diego medical device firm BURL Concepts is collaborating with Bracco Imaging to produce BURL's SONAS device, a portable system for assessing ischemic strokes.
August 1, 2024
Brain Stroke Stroke Social
Cyberattack delays blood deliveries to hospitals in Southeast
By LabPulse.com staff writers
More than 250 hospitals in the Southeast may be switching to critical blood shortage protocols due to a ransomware attack on provider OneBlood. Manual processes are keeping the center operational.
August 1, 2024
Cyberattack Hacker Social
Thermo Fisher Scientific gets FDA 510(k) clearance for multiple myeloma precursor assays
By LabPulse.com staff writers
Thermo Fisher Scientific received an extended 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Optilite Freelite assays for evaluating monoclonal gammopathy of undetermined significance, a precursor to multiple myeloma.
July 29, 2024
Multiple Myeloma Social
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