Diagnostic Technologies

Backlog of unresolved medical diagnoses leads to new method for clinical exome reanalysis
By Liz Carey
The automated analysis improved the rate of accurate genetic diagnosis, doubling the number of solved cases as compared with benchmarked methods, across three distinct real-world cohorts, according to researchers.
May 16, 2024
Child Hospital Social
Northwell Health Cancer Institute opens molecular diagnostics laboratory
By LabPulse.com staff writers
The Northwell Health Cancer Institute and its Center for Genomic Medicine have opened a new $3.2 million 2,800-sq-ft molecular diagnostics laboratory in Lake Success, NY.
May 13, 2024
Cancer Therapy Targeted Social
Qiagen gets FDA clearance for respiratory syndromic testing panel
By LabPulse.com staff writers
Qiagen announced that it has received U.S. Food and Drug Administration (FDA) clearance for its QIAstat-Dx respiratory syndromic testing panel for clinical use.
May 14, 2024
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Qiagen partners with FBI on forensics assay
By LabPulse.com staff writers
Qiagen has announced a collaboration with the FBI to develop a new assay to improve DNA quantification for use in forensics and human identification.
May 8, 2024
Lab Pcr Tubes Dna Social
University of Florida researchers develop CRISPR-based assay for HPV detection
By LabPulse.com staff writers
Researchers at the University of Florida have developed a testing method that utilizes CRISPR gene-editing technology to detect HPV in blood or saliva samples that could promote earlier cervical cancer detection.
May 7, 2024
Hpv Niaid Social
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
Money Hundred Bills Social
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
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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
Pathology Digital Workstation Microscope Social
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
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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
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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
Fda Button Social
Mission Bio launches new features for Tapestri platform
By Matt Limb
Mission Bio has launched new multiplexing features for its Tapestri platform, saying they will make single-cell technology more affordable and accessible to the biomedical community.
April 24, 2024
Test Tubes Social
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