Category: Lab Management

Lab Management

Siemens Healthineers Atellica Testosterone Assay Receives CDC Certification

The certification verifies that the automated immunoassay provides results equivalent to the gold standard method for measuring total testosterone.

Lab Management

Invivoscribe Launches Automated System Integrating Nucleic Acid Extraction and Quantification

Invivoscribe, in collaboration with Hitachi High-Tech, has launched the PrepQuant System, an automated platform that integrates nucleic acid extraction, concentration, and quantification to streamline molecular testing workflows.

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FDA Issues Draft Guidance for Gene Therapy Genome Editing Safety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

Blue Shield of California Expands Coverage for Metastatic CNS Cancer Assay

Blue Shield of California will cover Plus Therapeutics’ CNSide CSF assay for metastatic CNS cancers starting April 2026, expanding total covered lives to 81 million, according to the company.

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.