Thought Leadership | clinicallab

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

Photo of a nutrient agar plate with round colonies of orange and pink antimicrobial resistant organisms against a black background.

Combat Antimicrobial Resistance Through Diagnostic Precision

Jeanie Bach MSN, RN CCRN

PCR panels offer an effective way for clinical labs to fight the threat of AMR

Photo of a clinical laboratory professional wearing PPE pipetting prostate cancer screening samples in a laboratory biological safety cabinet.

Prostate Clarity: A New Noninvasive Biomarker for Prostate Cancer Screening

Niven R. Narain, PhD

AI-identified biomarker-based test reduces need for prostate biopsies in men with high PSA levels

Photo of a metal laboratory device in the manufacturing of reagents in the pharmaceutical and scientific assay industry.

Lyophilization Can Increase Accessibility to Point-of-Care Testing

Nathan Tanner, PhD, Gregory Patton, PhD

Lyophilized product advantages come from a specialized upfront development process

Photo of clinical laboratory professional wearing PPE and pipetting biomarker samples at a laboratory bench.

Supporting Biomarker-Driven Clinical Trials Through a Future-Ready Lab

Deborah Phippard, PhD

Steps that buttress biomarker analysis include laboratories adopting platform-agnostic technologies

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

Illustration and abstract photo of the gloved hands of a clinical researcher pipetting and culturing cells derived from patients to create patient-derived xenograft models.

Capturing the Complexity of Real Cancer Cases with Patient-Derived Xenograft Models

Michael J. Wick, PhD

Patient-derived xenograft models enable researchers to explore novel therapies and diagnostic tools within the context of specific mutational signatures, treatment histories, and more

Close up photo of a clinical laboratory technician’s hand wearing a blue glove and pipetting cytomegalovirus samples into a PCR tube and 96-well plate.

Congenital CMV Testing Paves the Way for Early Intervention and Healthier Outcomes

Samantha Thaver

1 in 5 babies infected with cCMV will have long-term health problems, making diagnosis and prompt disease management key to better outcomes

Two clinical laboratory scientists wearing PPE in the laboratory hold a clipboard and review the milestones toward the new FDA LDT Final Rule.

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know

Shannon Bennett, MS, MBA

As the first milestone of the new LDT Final Rule approaches, here are the key FDA terms laboratories need to understand

FDA Predetermined Change Control Plans May Aid LDT Modifications

Karin Hughes, PhD

A new PCCP draft guidance outlines what elements the agency expects in these plans

Image of the lobby of the OneLab VR facility.

Laboratory Training Goes Virtual

Joe Rothschild

The CDC’s OneLab VR lab environment offers an expanding suite of lab training scenarios in real-time from around the world

Medical laboratory scientists looking at test results

AI in Pathology Must Focus on the User Experience

Nathan Buchbinder, BS, MBID

It’s time to take a pathologist-centric approach to artificial intelligence

Photo of a blood test tube with a yellow cap next to a testing requisition for ANA testing for autoimmune disease.

Toward a Faster and More Accurate Psoriatic Arthritis Diagnosis

Tiffany Payne, MS

Experts discuss key challenges and advancements in diagnosing psoriatic arthritis and the importance of early diagnosis

Photo of pipette tips in the clinical laboratory with a blue background.

Steroid Hormone Analysis with Supel™ Swift HLB DPX

MilliporeSigma

Supel™ Swift HLB DPX is a valuable tool for steroid quantification in clinical settings, ensuring accurate and sensitive analysis

Lab worker in blue gloves trying to find lost tissue samples in storage

How Many Lost Tissue Samples Has Your Anatomic Pathology Lab Endured?

Denise Bland

Technology can help avoid this perennial problem for clinical laboratory managers