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DARK Daily Laboratory and Pathology News

DARK Daily is an e-briefing service providing up-to-the minute news of relevance for anyone working in diagnostic medicine, from clinical laboratories and pathology groups to lab industry suppliers and diagnostic technology companies. DARK Daily is part of The Dark Intelligence Group, Inc. and is dedicated to bringing useful business and management intelligence to laboratory managers, pathologists and diagnostic executives. Our recognized expertise in the strategic direction of laboratory medicine and the management of laboratories is available through DARK Daily, The Dark Report, free White Papers, Lab Resource Directory, the Executive War College on Laboratory and Pathology Management, Lab Quality Confab, and strategic consulting services.

Latest E-Briefings

Home-testing IVD Diagnostic Devices Win Rigorous MDEA Design Awards as Part of Ongoing Trend to Move Medical Laboratory Tests Closer to Patient

Innovative designs promote in vitro home-testing medical diagnostic devices that could impact the work done in clinical laboratories

With greater frequency, new diagnostic technologies make it possible to move medical laboratory tests out of the traditional central lab facility and closer to the patient—including patient home self-testing. Even as this happens, engineers and designers are delivering elegant, well-designed devices designed for use in clinical laboratories as well as in near-patient settings.

Evidence of this trend comes from the most recent winners in the annual contest known as the Medical Device Excellence Awards (MDEA). In this year’s contest, two of the products receiving awards were medical laboratory test devices that were deemed to be innovative solutions to improve the lab testing process.

This contest intends to “recognize significant advances in medical product design and engineering that improve the quality of healthcare delivery and accessibility.” The competition was first held in 1998 and is sometimes described as the “Oscars” of the medical device. Receiving an MDEA medal offers validation, publicity, and a host of other benefits. continue reading

Mayo Medical Laboratories Gathers Pathologists and Other Experts to Share Lessons Learned and Successes in Improving How Physicians Utilize Lab Tests

Utilization management of clinical laboratory testing is a big trend in laboratory medicine at the moment as innovative labs strive to add more value

DATELINE: DENVER, COLORADO—Interest in improving the utilization of clinical laboratory tests is at an all-time high among medical laboratories throughout the United States. Last week a national gathering of pathologists and laboratory professionals gathered in the Mile High City to share success stories and identify the best approaches to helping physicians better utilize lab tests.

This one-day conference on laboratory test utilization was organized by Mayo Medical Laboratories and the Mayo Clinic as part of its 27th Annual Conference on Laboratory Outreach. The keynote speaker was Michael G. Rock, MD, Chief Medical Officer at Mayo Clinic Hospitals/Mayo Foundation and an at-large member of the Board of Trustees of the American Hospital Association (AHA) and its Executive Committee.

Analysis of Key Trends in Healthcare

In recent years, Rock has been involved at the highest levels of healthcare strategy development, both at the Mayo Clinic and with several national hospital associations, including the American Hospital Association. He provided attendees at this conference with a razor-sharp analysis of key trends in healthcare. Rock then identified and explained the essential steps that innovative hospitals and health systems are taking to reshape their organization in order to provide the range of clinical services needed to support integrated healthcare and personalized medicine. continue reading

Clinical Laboratories and Pathology Groups May See Fewer Fee-For-Service Payments as More Hospitals and Health Systems Become Self-Insured

As national health insurers push more risk to hospital systems and medical groups, many hospital administrators become more interested in establishing their own health insurance companies

New modes of provider reimbursement—such as bundled payments and budgeted payments—are motivating hospitals and health systems to reconsider their existing relationships with health insurers. Hospital administrators want to control the dollars they save by improving patient care, instead of allowing insurance companies to capture that money.

To accomplish these goals, more and more hospitals and health systems across the country are making one of three moves:

• Funding their own health plans;
• Partnering with health insurance companies; or,
• Buying health insurance companies.

As this trend gathers momentum, it will put the medical laboratories of hospitals in a much better position to regain access to patients. It can be expected that hospital administrators will include their own clinical laboratories and anatomic pathology providers in their own health insurance provider networks. continue reading

New England Journal of Medicine Publishes Study Where Researchers Call Attention to Lack of Knowledge about Some Genes Included in Gene Panel Tests for Inherited Cancers

Researchers are concerned about the lesser-known genes included in the test and also point out that little published research exists to support use of these genes for clinical laboratory testing

Gene-panel tests for inherited cancers were scrutinized by a group of 17 prominent international genetic researchers in a study published by the New England Journal of Medicine (NEJM) this summer titled “Gene-Panel Sequencing and the Prediction of Breast-Cancer Risk.” These experts pointed out that, for many of the genes included in these test panels, there remains much uncertainty about their role in various cancers and other diseases.

What will be of greatest interest to pathologist, Ph.D.s, and medical laboratory professionals currently performing molecular diagnostics assays and genetics is that these experts proposed greater regulation of unvalidated gene-panel tests for inherited cancers. In the NEJM, the authors provided some examples of genetic tests, such as those offered by Myriad Genetics, Inc. (NASDAQ:MYGN), Ambry Genetics, Invitae (NYSE:NVTA), and Illumina, Inc. (NASDAQ:ILMN) and noted that risks posed by many mutations occurring on these panels are unknown.

These panel tests can include more than 100 genes, 21 of which are an indication of breast cancer, including BRCA1 and BRCA2, stated the paper. continue reading

Medical Scientists Call for Standard Method for Validating Antibodies Used in Research and Clinical Laboratory Diagnostics

Antibody validation standards would help ensure reproducibility of research studies and improve the consistency medical laboratory test results

As science and industry gets better at measuring things and assessing quality, the acceptable standard often comes into question. This seems to be happening with antibodies, the most common reagents used in diagnostics, clinical laboratory diagnostic tests, and medical research. In many cases, the end result is that companies and their suppliers must use new technologies and quality methods to revise the “old way” and create products that have measurable better quality.

The techniques currently used to validate antibodies is the topic of a recently-published scientific paper. The authors of a paper published in the March, 2010, issue of Biotechniques pointed out, antibody validation and standardization ensure study reproducibility, which is critical to accuracy. And yet, no standard guidelines define how these important biological tools should be validated prior to use.

Thus, researchers participating in a recent webinar, presented by The Scientist expressed concern that—without improved antibody validation and standardization—the accuracy of published research is in question and diagnostic test results, such as those produced by medical laboratories, will continue to be inconsistent. continue reading

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