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|2 min read

Mass General Brigham Validates Polygenic Risk Score Tool for Predicting 8 Cardiovascular Conditions

New integrated polygenic risk score test, now available across the US, may help identify patients at elevated inherited risk for cardiovascular disease before traditional clinical factors emerge
|3 min read

Sapio Sciences Integrates Claude AI, Aiming to Simplify Lab Data Access

Integration of Anthropic’s Claude AI assistant with Sapio Elain aims to unify data retrieval, analysis, and workflow automation across ELN and LIMS from a single conversational interface
|3 min read

New Compact Imaging Device Enables Rapid, Label-Free Cancer Tissue Analysis Without Staining

A miniaturized metasurface-based system captures full tissue imaging data in a single acquisition, supporting faster, stain-free analysis and future portable diagnostic workflows
|2 min read

CMS, FDA Launch RAPID Coverage Pathway for Breakthrough Devices

New regulatory alignment initiative aims to shorten the gap between FDA authorization and Medicare coverage decisions for eligible medical devices
|2 min read

QuidelOrtho Acquires LEX Diagnostics, Expands Ultra-Fast PCR Platform

QuidelOrtho has acquired LEX Diagnostics, adding a CLIA-waived multiplex RT-PCR system delivering respiratory results in less than 10 minutes
|2 min read

Labcorp Launches FDA-Cleared 10-Minute Rapid Fentanyl Urine Test

New point-of-care test detects fentanyl metabolite norfentanyl, extending detection up to 48 hours to support faster clinical decisions in acute care settings
|1 min read

Engineered PCR and Isothermal Enzymes Aim to Accelerate Molecular Diagnostics Workflows

Watchmaker Genomics launches new PCR and RPA enzyme systems designed to improve speed and performance in molecular diagnostics
|2 min read

Quest Expands Haystack MRD ctDNA Testing in City of Hope Cancer Trials

A multi-site study will evaluate how a ctDNA assay may support residual disease detection and treatment monitoring in solid tumors
Updated |4 min read

Closing the Diagnostic Gap in CNS Infections

mNGS supports faster diagnosis and targeted treatment in meningitis and encephalitis
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|5+ min read

7 Emerging Trends Shaping Clinical Labs in 2026

Expert perspectives on how AI, data governance, genomics, patient-centric care, and other emerging trends are shaping the future of clinical labs
|2 min read

TLDR; Our Top Stories of 2025

From regulatory shifts to breakthrough diagnostics, the stories that defined clinical labs in 2025
|5 min read

The Year of 'Regulatory Whiplash' and the AI Pivot: 2025 in Review

If 2024 was defined by the looming threat of the FDA's "Final Rule" on laboratory-developed tests (LDTs), 2025 was defined by its sudden dismantling
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