Aug 26, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
FDA issues press release following clearance of a clinical lab test to detect genetic markers that indicate the presence of Carbapenem-resistant Enterobacteriaceae
Clearance by the US Food and Drug Administration (FDA) of a new rapid, multi-marker genetic test designed to identify bacteria that are resistant to Carbapenem antibiotics was considered significant enough that the federal agency issued a press release announcing that the test was cleared and now available for use by physicians and clinical laboratories in the United States.
In the race to develop molecular assays and genetic tests for infectious disease that deliver improved sensitivity and specificity with a faster time-to-answer, this new test offers all three benefits. Results are available in just 48 minutes, for example.
It was on June 29, 2016, that the FDA cleared Cepheid’s Xpert Carba-R rapid-diagnostic test for marketing in the United States. This is the first clinical laboratory test cleared for market by the FDA that detects healthcare-associated infections (AKA, hospital-acquired infections or HAIs) through the use of genetic markers taken directly from clinical samples. The assay tests for genetic markers that indicate the presence of Carbapenem-resistant Enterobacteriaceae (CRE). (more…)
May 9, 2016 | Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing
Latest calls for easier public access to information on physician performance and quality is a reminder to clinical laboratories and pathology groups of the trend to greater transparency on provider outcomes
If any clinical laboratory executive or pathologist still doubts that more transparency of provider outcomes is a topic of interest to patients, they have only to look at Consumer Reports, well-respected for its advocacy on behalf of consumers. Consumer Reports is using multiple ways to educate their readers about medical errors and how the medical community makes it difficult for consumers to learn about physicians who have been involved in state medical board investigations.
One example is the Consumers Union, which is the policy and advocacy arm of Consumer Reports. Through its Safe Patient Project, the Consumers Union seeks to eliminate medical harm in healthcare.
Consumers Union advocates for increased public disclosure of information about such issues as: (more…)
Nov 4, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Pathology, Laboratory Testing, Management & Operations
MinION could help achieve NIH’s goal of $1,000 human genome sequencing and in remote clinics and outbreak zones shift testing away from medical laboratories
Point-of-care DNA sequencing technology is edging ever closer to widespread commercial use as the Oxford Nanopore MinION sequencer draws praise and registers successes in pre-release testing.
A pocketsize gene-sequencing machine such as the MinION could transform the marketplace by shifting DNA testing to remote clinics and outbreak zones while eliminating the need to return samples to clinical laboratories for analysis. Such devices also are expected to increase the need for trained genetic pathologists and medical technologists. (more…)
Dec 13, 2013 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Pathology
Pathologists and clinical laboratory managers can expect environmental microbiome detection and monitoring to play an increasingly important role in disease diagnosis, treatment and prevention
For decades, microbiologists and clinical laboratory professionals have prowled the corridors of hospitals to swab physicians’ neckties, the hands of nurses and staff, and various surfaces. These swabs were then cultured to demonstrate how easily infectious microbes can be transmitted in everyday activities.
Now researchers, including microbiologists, are combing the New York City subway system to swab surfaces, collect specimens, and create a map of the urban microbiome. Researchers at Weill Cornell Medical College in New York City want to use the microbiome to pioneer a new method for city-level pathogen monitoring. (more…)
Oct 7, 2013 | Laboratory Hiring & Human Resources, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations, News From Dark Daily
A sold-out audience gathered at the seventh annual Lab Quality Confab and heard speakers from the nation’s most innovative medical laboratories share case studies about success in cutting lab expenses and improving quality
DATELINE: NEW ORLEANS, LOUISIANA—At a time when medical laboratories in the United States are experiencing significant financial challenges, there was plenty of guarded optimism among the clinical laboratory managers and pathologists who gathered in this famous city last week for the seventh annual Lab Quality Confab.
One reason for this optimism is that speakers and attendees at this sold-out meeting are the nation’s leading experts in the use of Lean, Six Sigma, and process improvement methods in medical laboratories and pathology groups. They know how to cut lab costs while maintaining quality and boosting the productivity of the lab’s staff and automated systems. (more…)
