Ivd News, Articles | Today's Clinical Lab

Photo of a medical laboratory professional wearing a white lab coat and standing in the clinical lab with their hands in their pockets.

District Court Overturns FDA’s LDT Rule: What the Ruling Means for Clinical Labs Now

Christine P. Bump

Under the district court’s vacatur, the LDT final rule and its compliance deadlines are no longer in effect and cannot be enforced

UK and European Experts Release Landmark Clinical Guidance for Breast Cancer Prevention

Antegenes

This new publication sets the standard, enabling more personalized and targeted breast cancer prevention and detection

Photo of the front of the US Capitol Building, the seat of the United States Congress, with a USA flag flying in front and blue sky and clouds in the background. ADLM hosted a congressional briefing on laboratory-developed tests there on February 20, 2025.

Ensuring Quality Pediatric Care Through Laboratory-Developed Tests

Association for Diagnostics and Laboratory Medicine

ADLM congressional briefing explains the importance of laboratory developed tests for pediatric care and the FDA rule that will limit access to these critical tests

With BD selling its diagnostics and life sciences business, clinical labs may see a new player could emerge in the IVD market.

What BD Selling Its Diagnostics Business Could Mean for Clinical Labs

Scott Wallask, BA

Becton Dickinson’s plans will shift the IVD market and possibly create a stronger contender

Photo of a document folder with the word “IVDR” on it in bold red letters and other office supplies on a desk.

EU IVDR 2017/746: Impact to Clinical Laboratories and Drug Developers

David Latto, PhD, Jill Haizlip, BS, MBA

How central labs can mitigate IVDR impact

A group of red flamingos standing in a pond—flamingos have been known to be infected and die from H5N1 bird flu infection.

Hologic to Contribute to H5N1 Bird Flu Test Development via Agreement Issued by CDC

Hologic

To prepare for if the current H5N1 outbreak worsens, Hologic will work with the CDC to develop reagents that may be used for H5N1 testing

Photo of a book open on a library table with a gavel on top of it with book stacks in the background.

What Latest EU 2024/1860 Amendment Means for IVD Manufacturers

Oliver Eikenberg, PhD

Key deadlines and questions in vitro diagnostic manufacturers need to consider to comply with IVDR Amendment EU 2024/1860

Hamilton's innovative Verso Dx is an automated postanalytical storage system that caters to different workflows thanks to its ability to load samples either manually or via lab track.

Emerging Technologies Guide: November 2024

Today's Clinical Lab

Recent new and emerging technologies in the field of laboratory medicine from the 2024 November Genetics & Genomics issue of Today's Clinical Lab

Photo of a group of clinical laboratory professionals wearing white lab coats and blue gloves in the lab and taking notes while learning about clinical lab compliance.

FDA, CLIA, and ISO—Which Regulations Apply to Your Clinical Lab?

Michael Schubert, PhD

Experts Julie Ballard and Lindsay Strotman help you navigate the complexities of FDA, CLIA, and ISO standards for the clinical lab

Image showing coins surrounding an idea lightbulb. The Laboratory Integration Strategic Association is leading an effort to crowdsource LDT development in reaction to FDA regulations.

First Ever Effort to Crowdfund Diagnostic Assays Launches in Response to FDA LDT Final Rule

LISAbio

LISA CEO explains why crowdfunding is a viable way to shoulder the new regulatory costs behind laboratory-developed tests

IVD