Today's Clinical Lab - News, Editorial and Products for the Clinical Laboratory

Crowdfunding Solutions for CAP/COLA Labs to Overcome FDA LDT Rule Costs

LISAbio

Learn how clinical labs can leverage crowdfunding to reduce diagnostic test development costs and meet FDA LDT compliance requirements

Photo of an ovarian cancer patient in the hospital undergoing treatment for ovarian cancer.

AI ‘Liquid Biopsies’ Using Cell-Free DNA, Protein Biomarkers, Could Aid Early Detection of Ovarian Cancer

Johns Hopkins Medicine

The blood test that uses artificial intelligence (AI) to detect cancer-related genetic changes and protein biomarkers could help screen women for early signs of ovarian cancer

: Image of Congress with a backdrop of a hundred-dollar bill. PAMA cuts to clinical lab services were avoided by a recent vote in Congress.

PAMA Cuts Averted Again for Clinical Lab Services

Scott Wallask, BA

ACLA applauds congressional action to delay Medicare decreases and urges long-term reform

Illustration of a DNA base pairs helix against a dark blue background.

QIAGEN Launches QIAcuityDx Digital PCR System for Clinical Testing in Oncology

QIAGEN

Enhances efficiency and reduces costs with all-in-one instrument for either IVD assays or tests designed and used by laboratories, user-friendly software and flexible scheduling features

Photo of a clinical laboratory scientist wearing PPE pipetting a DNA sample dyed with dark blue nucleic acid dye into a 96-well plate for forensic DNA testing inside of a biological safety cabinet.

AI Promises to Ramp Up PCR Tests for Faster DNA Diagnostics and Forensics

Flinders University

Promising new inroads into critical DNA testing forecast by experts applying machine learning to DNA profiling

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

Photo of several different blister packs of different-colored medications.

Enterprise Therapeutics Granted ‘Rare Pediatric Disease Designation’ in the US for Novel Cystic Fibrosis Investigational Therapy ETD001

Enterprise Therapeutics

ETD001 commenced Phase 2 clinical trials in July 2024, expected to complete in 2025

Photo of a woman sitting in a hospital chair with an IV and undergoing treatment for ovarian cancer.

Ovarian Cancer Test Receives CPT Code and Preliminary Payment Determination from CMS

ClearNote Health

The new CPT code establishes a reimbursement pathway for increased access and broader test adoption for patients at high risk for ovarian cancer

Illustration of a network of different health care and laboratory symbols against a blue background to represent data management and data analysis in clinical research.

CRDSA Announces New Standards for Clinical Trial Data Reuse

Clinical Research Data Sharing Alliance

The new standards aim to facilitate responsible sharing and use of anonymized individual patient data from clinical studies to support research and accelerate the discovery and delivery of new therapies

Illustration of red bacterial pathogens on a black background.

QIAGEN Receives EU IVDR Certification for QIAstat-Dx Syndromic Testing Instruments and Assays

QIAGEN

Product line earns CE-marking under new EU IVDR framework—including QIAstat-Dx Analyzer, QIAstat-Dx Rise and panels for detection of gastrointestinal and respiratory infections

Photo of a Black woman in the background holding up a pink ribbon to represent breast cancer awareness.

Fibrosis Identified as a Prognostic Indicator in the Most Common Breast Cancer, Paving the Way for Antifibrotic Drug Treatments

Spanish National Cancer Research Centre

For the first time, researchers have shown that the presence of fibrosis in HER2-negative breast tumors is associated with an adverse prognosis

Illustration of abstract circles inside circles in different colors against a black background representing the concept of genomics networks.

NIH Awards $27M to Establish New Network of Genomics-Enabled Learning Health Systems

National Human Genome Research Institute

Network will analyze and improve how genomic information is integrated into patient care

Microscope image of 3D organoids cultured from esophageal cancer.

Unlocking the Potential of Patient-Derived Organoids for Personalized Sarcoma Treatment

UCLA Health

By using 3D mini tumor models that closely resemble a patient's tumor, treatments could be tailored more effectively, paving the way for more personalized cancer treatments

Image of Tosoh Bioscience’s G8 analyzer, one option for medical labs in the clinical chemistry analyzer market.

Clinical Chemistry Analyzer Market on the Rise: What’s Driving Demand?

Scott Wallask, BA

To capture new demand, clinical labs should note advancing technology and rising disease mortality

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