Category: Lab Management

Lab Management

Labs Say They’re Automated. The Workflow Tells a Different Story

Many labs consider themselves automated, but manual steps persist. Here’s where automation is working, where it’s falling short, and how some labs are starting to close the gaps.

Lab Management

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.

Lab Management

Bringing Clarity to Autoimmune and Allergy Diagnostics

As autoimmune and allergy test volumes rise, labs are prioritizing workflow standardization and structured testing pathways to ensure reliable results, according to Santhosh Nair, president of immunodiagnostics at Thermo Fisher Scientific.

Accreditation

LuminoDx Earns CAP Accreditation for Diagnostic Testing Facility

The accreditation covers liver health diagnostics, including Hepatotrack, a molecular diagnostic liquid biopsy that is predictive of acute liver rejection post-liver transplant.

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FDA Issues Draft Guidance for Gene Therapy Genome Editing Safety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

FDA Grants Breakthrough Status to Liquid Biopsy for Liver Cancer Monitoring

TCM Biotech has received FDA Breakthrough Device Designation for CatCHimera, a liquid biopsy platform for monitoring minimal residual disease in hepatocellular carcinoma using HBV–host genome integration biomarkers.

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.