View My Shopping Cart
Sign Up
____________________________________________________________________________

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

Wearable Health-Monitoring Devices Could Alter Traditional Role of Pathologists as Gatekeepers of Medical Laboratory Test Data

Consumers embrace wearable health-monitoring technology as developers find new ways to transfer collected health data directly into patient records

Traditionally, medical laboratories have been the gatekeepers for the lab test data of most patients. After all, it is regularly said that 70% or more of a patient’s permanent health record is made up of clinical laboratory test data. However, several market forces are at play that could eat away at the long-standing role of medical laboratories as the primary gatekeepers of patient test data.

Today, consumers increasingly want to use wearable devices that not only track their health and fitness, but are designed to also eventually stream self-monitored health data directly into clinical data repositories. As these wearable devices are cleared to use the same biomarkers involved in clinical laboratory tests to monitor the wearer’s health condition, then these devices will stream that data into the electronic health records (EHR) of patients with chronic diseases. continue reading

Finding Genomes with ‘Knockout’ Genes Leads to Development of New Therapeutic Drugs, along with Clinical Laboratory Tests for these Biomarkers

Drugs based on knockout genes are expected to trigger the need for companion diagnostic tests that will be performed by pathologists and medical laboratory scientists

Pharmaceutical companies and other research programs are developing a new opportunity to use information from human genome sequencing to create a new class of therapeutic drugs. These drugs target “knockout genes” and those same genes are expected to be used as diagnostic biomarkers for clinical laboratory testing as a new field of companion diagnostics emerges.

In simplest terms, large-scale DNA sequencing of the human genome is enabling researchers to identify individuals with “knockout” genes and then develop therapeutic drugs based on that knowledge.

The first commercial success story from this partnership of geneticists and the pharmaceutical industry is expected to be a new class of drugs that lowers cholesterol. These drugs may reach pharmacy shelves this year, reported an October 24 Nature article. continue reading

Scanadu is Preparing Consumer Self-Test Device for Review by the FDA as Part of Its Mission to Enable Patients to Monitor Their Health without the Need for Clinical Pathology Laboratory Tests

Scanadu’s device is called the ScanaFlo and is designed to collect biometric data from consumers using a variety of methods, including urine specimens

Now gathering study data needed to launch a review by the Food and Drug Administration (FDA) is a low-cost lab urinalysis device that returns results via a smartphone for conditions such as pregnancy and diabetes. More significant for pathologists and clinical laboratory executives, this handy point-of-care device is capable of doing tests for traditional medical laboratory tests, ranging from glucose and leukocytes to bilirubin and creatinine.

The device was invented at Scanadu, Inc., a health-tech startup based at NASA Ames Research Center in Mountain View, California. It is a new low-cost lab urinalysis kit that uses a smartphone to return test results on liver, kidneys, urinary tract, and metabolic functions. The company uses imaging and sound analysis, molecular diagnostics, data analytics, and a suite of algorithms to create devices that offer consumers comprehensive, real-time health data on mobile devices. continue reading

Use of “Long Read” Gene Sequencing Allows University of Washington Researchers to Uncover Thousands of Never-before Seen Gene Variations

This and similar research initiatives expected to increase the number of genetic markers that would be useful for creating clinical pathology laboratory tests and therapeutic drugs

Whole human genome sequencing continues to become faster, easier, cheaper, and more accurate to do. Because of these advances, the sheer number of human genomes being sequenced is skyrocketing. This huge increase in data is helping researchers unlock many new insights that, in turn, are fueling efforts to develop useful new medical laboratory tests and therapeutic drugs.

This is happening at the University of Washington (UW), where researchers using new genome sequencing technology are uncovering thousands of never-before-seen genetic variants. The application of “long read” gene sequencing technologies is allowing these researchers to identify genetic variants previously unknown, and that are made up of between 50 and 5,000 base pairs.

The discovery is important for two reasons. First, it could close existing gaps in the genome map. Second, it could help scientists identify new genomic variations that are closely associated with difficult-to-diagnose diseases. Of interest to pathologists and clinical laboratory professionals, such discoveries could point to expanded use of genetic testing for diagnosis and treatment of disease. continue reading

Creating Added Value from Clinical Pathology Laboratory Testing Produced Improved Outcomes at University of Mississippi Medical Center and Broward Health

Innovative medical laboratories shared their successes in improving lab test utilization that included physician engagement and close monitoring of key metrics

DATELINE: ORLANDO, FLORIDA—One big challenge facing medical laboratories  and anatomic pathology groups in the United States today is the need to transition from a transaction-based business model (increasing specimen volume leads to increasing revenue) to a value-based business model (helping providers improve their use of clinical laboratory tests in ways that measurably improve patient outcomes while controlling or reducing the cost of care.)

Two trends reinforce the need for clinical laboratories to craft strategies to develop new ways to add value to lab testing services.

One trend is the move by Medicare and private health insurers to shift reimbursement for providers away from fee-for-service  and toward bundled reimbursement and budgeted reimbursement.

The second trend is the emergence of integrated clinical care organizations. The most visible of these are accountable care organizations (ACO) and patient-centered medical homes (PCMH). What these care delivery organizations have in common is that they require hospitals, physicians, clinical laboratories, imaging centers, nursing homes and other types of providers to work together more effectively so that patients receive healthcare in a seamless fashion because there is a continuum: primary care to specialty care to acute care and back again. continue reading

Daily E-Briefings

DARK Daily

DARK Daily is a free e-briefing service that provides one short, easy-to-read news item every weekday, highlighting noteworthy developments in the clinical laboratory industry. First alerts to important news events, incisive assessment of best-practice breakthroughs, and strategic insights on important trends make these e-briefings timely and invaluable. Sign up for the DARK Daily today and receive the special report Trends In Clinical Pathology Laboratory Management free.

The Dark Report

Since its founding in 1995, The Dark Report has been the laboratory industry’s most reliable source for useful business intelligence and innovations in the management of clinical laboratories and pathology group practices. Widely-read and much discussed, The Dark Report is respected as a source of knowledge and information that allows lab administrators, pathologists, and industry executives to be first to learn about the latest facts and trends that affect medical laboratories of all kinds.

Professional Services

Strategic Consulting

With a demonstrated track record of success, Robert Michel and the team at The Dark Intelligence Group, Inc. deliver strategic insight and market analysis that directly leads to increased revenues, improved profitability, and operational excellence. Having continuously worked with and visited laboratories, pathology groups, and lab industry vendors for more than 12 years, Robert Michel brings a unique set of skills and experience to any strategic challenge or opportunity.

Meeting Facilitation

Energize your next public meeting, strategic retreat, or corporate event. Widely-recognized and often asked back for a second and third year, Robert Michel has a recognized ability to help audiences get more from the speakers and advance their knowledge and understanding about key trends and management innovations. One- and two-day management retreats are a specialty.

Public Presentations

For a dynamic and knowledgeable public speaker to turbo-charge your next meeting, contact The Dark Intelligence Group. When it comes to management of clinical laboratories and pathology group practices, Robert Michel and his colleagues are consistently ranked among the industry’s keenest minds.

Copyright © 2013-2015 the Dark Intelligence Group, Inc. All rights reserved. Reproduction in whole or part without permission is prohibited. We Value Your Privacy! The Dark Intelligence Group will never sell, rent or otherwise abuse your email address. It will be used solely for the purpose of sending you the Dark Daily newsletter and updates about the Dark Daily. Should you wish to unsubscribe at any time, instructions are included with each email for immediate removal from the Dark Daily newsletter subscriber file.