Ivd News, Articles | Today's Clinical Lab

While this decision validates CLIA’s role, the history of this debate begs some practical considerations to inform both immediate decisions and long-term strategies.

Leveraging Regulatory Clarity in LDTs to Drive Laboratory Innovation

Jamie Platt, PhD

What steps should your lab take in response to shifting LDT oversight?

This marks a significant milestone for clinical laboratories in the United States.

AliveDx's MosaiQ® Platform Registered with FDA as Class II 510(k) Exempt, Enabling US Labs to Adopt High-Throughput Automated Immunoassay Testing

AliveDx

MosaiQ is a next-gen immunoassay platform delivering automated, multiplexed testing and actionable insights for complex conditions

Greener Clinical Lab Testing Now Within Reach: New Solutions from Siemens Healthineers

Siemens Healthineers

The Atellica instruments from Siemens Healthineers are now My Green Lab ACT Ecolabel certified

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Under the district court’s vacatur, the LDT final rule and its compliance deadlines are no longer in effect and cannot be enforced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

IVD