Management & Careers Articles

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

: 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

Photo of a diverse group of five laboratorians wearing white lab coats in a clinical laboratory and smiling at the camera.

5 Clinical Laboratories Leading the Way in Patient Care

Michael Schubert, PhD

Trailblazing labs are among the first to adopt new tests and treatments for longstanding challenges

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

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

Maximize Lab Operations with an Efficient Water Purification System

MilliporeSigma

Improve patient care with laboratory water systems–reducing maintenance burdens, and ensuring reliable test results

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

Illustration of a human face with smoke stacks releasing polluted air into the human face, representing air quality issues.

Improving Indoor Air Quality in Clinical Laboratories: Best Practices for Safety and Compliance

Michael Schubert, PhD

A guide to indoor air quality in the clinical lab—understanding the hazards, monitoring risk, and taking action to prevent issues

Improve Experimental Efficiency with Advanced Water Purification

ELGA

Integrated high-purity water systems can enhance accuracy, reduce downtime, and optimize workflows

Photo of a multiracial team of clinical laboratory scientists wearing PPE and working in a CLIA-certified laboratory environment on companion diagnostics.

Agilent Unveils Biopharma CDx Services Lab to Accelerate Precision Medicine

Agilent Technologies

New CLIA-certified lab ensures seamless transition from early assay development and testing to full companion diagnostics commercialization

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

ISO standards shown in a schematic drawing design

A2LA Accredits First Clinical Laboratory in US to New Version of ISO 15189

A2LA

ADL Health meets requirements of ISO 15189:2022, the latest version of the standard

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

Battling Rabies and Beyond: A Molecular Epidemiologist’s Perspective of the Medical Laboratory Sciences

María Carla Rosales Gerpe, MSc, PhD

Texas State University Regents’ Professor Rodney E. Rohde, PhD, reminisces about how he found himself amid the 1990s Oral Rabies Vaccination Program as a first-generation university graduate

Webinar Recap: LDT Compliance Requirements for FDA Final Rule

Christine P. Bump

Christine P. Bump shares key insights from the FDA’s August 22 webinar on LDTs compliance

Photo of the entrance of the 2024 ADLM Lab Expo.

ADLM 2024 Highlights Point-of-Care and Sepsis Innovations

Tyler Radke, MLS(ASCP)CM

First-time attendee explores new technologies and future solutions at the Association for Diagnostics in Laboratory Medicine Annual Lab Expo

Photo of the letters F, D, and A, representing the US FDA, on wooden blocks with pills in the background.

Association for Molecular Pathology Challenges FDA in Lawsuit against Final Rule on Laboratory-Developed Test Regulation

Association for Molecular Pathology

Drastic policy change will stifle diagnostic innovation, impose billions of unnecessary dollars in healthcare mandates, and threaten patient access to essential medical procedures