Category: Lab Management

Lab Management

Roche Receives CE Mark for Alzheimer’s Disease Blood Test

Roche has received CE mark approval for its Elecsys pTau217 blood test, designed to aid in Alzheimer’s disease diagnosis by detecting amyloid pathology in patients with cognitive decline.

Lab Management

GRAIL to Present New Data on Multi-Cancer Early Detection Test

Presentations will feature results from the NHS-Galleri and PATHFINDER 2 studies involving more than 174,000 participants.

Lab Management

FDA Grants Breakthrough Status to Blood Test to Distinguish Schizophrenia and Bipolar Disorder

The mRNA-based test aims to provide objective data to help clinicians distinguish between psychiatric conditions that often share symptoms.

Accreditation

Amplified Sciences Receives CAP Accreditation for Clinical Diagnostic Laboratory

Amplified Sciences has received CAP accreditation for its clinical laboratory, enabling broader commercial deployment of its PanCystPro assay for pancreatic cancer risk assessment, the company announced.

Compliance

FDA Issues Draft Guidance for Gene Therapy Genome Editing Safety

The recommendations focus on using next-generation sequencing to evaluate off-target editing risks and chromosomal integrity.

Proficiency Testing

Managing Reagent Variation

Lot-to-lot reagent inconsistencies can have significant effects on patient test results.

Company News

CareDx to Acquire Oncology Diagnostics Company Naveris for $160 Million

CareDx will acquire Naveris for $160 million, adding a Medicare-reimbursed liquid biopsy platform for viral-mediated cancer monitoring to its precision medicine portfolio.

Resource Center

ADLM 2026 and the Ideas Shaping the Clinical Lab

This clinical lab conference spotlight looks at why ADLM 2026 belongs on the radar for CLP readers. From the scientific program to the Clinical Lab Expo, the event offers practical ideas, fresh technology, and real conversations for people working across diagnostics and laboratory medicine. For lab professionals who want useful insight, sharper perspective, and stronger industry connections, this is a smart place to be.