• Managing Up

    Designing, upgrading, and choosing the right instruments for a clinical lab are complicated tasks. Even for experienced laboratory directors and managers, it isn’t always apparent how such processes should be conducted, or…
  • Targeting Antibiotic Resistance

    The global diagnostic response to antibiotic resistance is a work in progress.
  • FDA Regulation in Clinical Labs

    According to FDA, today’s laboratory-developed tests are frequently manufactured using components and instruments that are not legally marketed for clinical use, and often rely on high-technology instrumentation and software to generate results…
  • Lipid Screening for Cardiovascular Disease

    Developments in lipid testing over recent years may signal a better alternative to taking cholesterol levels when it comes to evaluating patients at risk for cardiovascular events.
  • Risk Assessment for Clinical Labs

    Shifting interpretations of the CLIA guidelines will allow clinical laboratories to develop alternative quality control policies, replacing equivalent quality control procedures, as of January 1, 2016. Rose Mary Casados, president of COLA…
Torrey Pines Scientific_EchoTherm_500

Equipment

Vibration-Free Incubators for Protein Crystallization

Peltier-based EchoTherm incubators are suited for life science heating and chilling applications requiring vibration-free operation.
Nonin overall line_mobile workstations_500

Equipment

Mobile Workstation Provides Customized Solution

Mobile bases for workbenches and workstations maximize user convenience and enable customers to reconfigure their workspaces easily.
Cepheid_XpertEbola

Product News

FDA Grants Emergency Use Authorization for Ebola Diagnostic Test

Delivering results in less than 2 hours, the Xpert ebola test has been authorized for use by CLIA moderate- and high-complexity laboratories or similarly qualified non-US laboratories.

Industry News

AMP to FDA: Focus on Performance Characteristics of NGS Devices

In written comments to FDA, the Association for Molecular Pathology argues that the agency should refrain from regulating the design, validation, and interpretation of next-generation sequencing procedures.
Arrayit_SuperGold SuperSilver_500

Misc. Supplies

Gold and Silver Microarray Substrates Provide Durable Surfaces

SuperGold and SuperSilver substrates are designed to bring quick, easy implementation and affordability to gold-surface and silver-surface based assays.
Elimination of visual barriers and close proximity of workstations promotes lab efficiency and communication among lab techs. Photo courtesy Laboratory Alliance of Central New York.

Lab Operations

Professional Consultants Tackle Lab Improvement

Clinical laboratories want to plan for ways to improve their workflow, reduce turnaround time, and efficiently use labor and financial resources, while balancing the need to improve quality.
http://www.dreamstime.com/royalty-free-stock-photos-abstract-lines-image1292928

Lab Operations

Managing Up

Designing, upgrading, and choosing the right instruments for a clinical lab are complicated tasks. Even for experienced laboratory directors and managers, it isn’t always apparent how such processes should be conducted, or how a lab should go about ensuring that its specific needs are addressed.
Halasey

CLP Blog

From the Editor: Managing for the Future

For an increasing number of laboratory directors and managers, coping with shifts in the healthcare marketplace is an everyday reality. But those who are prepared may see the challenges of such change as opportunities as well.
Photo KleinRogerD

Q&A

Inside Track: AMP Updates DTC Policy

CLP spoke with Roger D. Klein, MD, JD, FCAP, medical director for molecular oncology at the Cleveland Clinic, and chair of the Association for Molecular Pathology ’s professional relations committee, to find out more about AMP’s revised policy on direct-to-consumer genetic testing,
MicroFlow I Image

Equipment

Self-Contained Workstation Collects Nonhazardous Fumes, Particulates

Self contained and easily moveable, the MicroFlow I workstation comes with an integral recessed work surface to contain spills.
Verigene_BCGN

Testing/Diagnostics

Test Provides Rapid Diagnosis of CRE “Superbugs”

After three recent outbreaks of carbapenem-resistant Enterobacteriaceae cast a light on the dangers associated with multi-drug-resistant infections, Nanosphere recently reaffirmed the clinical benefits of its Verigene gram-negative blood culture test.
PositiveID_Firefly Dx

Industry News

PCR-Based Pathogen Detection System Completes First Round of Testing

PositiveID Corp has completed a first round of testing for its handheld, real-time polymerase chain reaction-based pathogen detection system, which reportedly delivers positive results within 20 minutes.
Atreo Single Latch Carrier

Equipment

Single-Latch Pneumatic Carrier Offers Safe Transport of Specimens

The pneumatic tube system carrier’s design enables users to use one hand to hold the unit while using the other hand to load contents and latch it shut.
Alpha-Tec_OxA Oxalic Acid kit

Testing/Diagnostics

Oxalic Acid Reagent Kit Delivers Complete Specimen Processing System

The OxA oxalic acid reagent kit is designed to digest, neutralize, and resuspend clinical specimens properly for the improved recovery of Mycobacterium spp from specimens containing Pseudomonas spp.
Ronald Jubin, PhD, founder and president of IES Diagnostics

Testing/Diagnostics

IES Diagnostics Identifies Body’s Immune Signature for Lupus

IES is launching a crowdfunding campaign to develop the first clinical diagnostic test for systemic lupus erythematosus, based on the unique interferon signature of the disease.
Brunel

Industry News

Biodesix and Inivata Partner to Develop Tests for Advanced Lung Cancer

Under a new agreement, Biodesix and Inivata will investigate the clinical utility of blood-based next-generation sequencing tests for patients with non-small cell lung cancer.
Klausner

Industry News

Illumina Collaborates with Merck Serono to Expand Companion Diagnostics for Oncology

The new partnership will focus on creating a universal test system for clinical trials of targeted cancer therapies, with the goal of developing a more comprehensive tool for precision medicine.

Studies/research

Miami Presentation Highlights Agendia’s BluePrint Molecular Subtyping Assay

Data from the ongoing NBRST trial suggest that Agendia’s BluePrint 80-gene molecular subtyping assay more accurately identifies molecular subgroups and may be a better guide for neoadjuvant chemotherapy than IHC/FISH assays.

Industry News

Omnyx and Argent Global Services Take Aim to Transform Digital Pathology

A new collaboration focused on digital pathology enhances cutting-edge capabilities to improve workflow and reliable, consistent processes.

Studies/research

Study Examines Diagnostic Accuracy of Pathologists Interpreting Breast Biopsies

In a study of breast biopsy interpretations, concordance between individual pathologists and an expert consensus panel was just 75%, suggesting a need for a formal second opinion in many cases.