News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Supreme Court Agrees to Consider Myriad Case Involving Human Gene Patents

Pathologists and clinical laboratory managers will likely learn next year whether Myriad’s gene patents will stand

In the ongoing debate about gene patents, the nation’s highest legal authority is about to weigh in on the question. The Supreme Court has agreed to hear the Myriad Genetics patent case in the upcoming term. The case turns on whether human genes can be patented.

Will Clinical Labs Need to Pay Royalties for Using Human Gene Patents?

How the high court rules on this matter has significant implications for clinical laboratories and pathology groups throughout the United States. That’s because holders of patents on human genes require medical laboratories to pay royalties for the clinical testing they perform. (more…)

Whole Gene Sequencing for Diagnosis Is Goal of Beth Israel Deaconess Medical Center and GenomeQuest in a New Collaboration

Goals are to use whole gene sequencing to develop better clinical laboratory assays in support of personalized medicine

Creating new clinical laboratory tests to support personalized medicine is one goal of a unique collaboration recently announced that involves the pathology department at Beth Israel Deaconess Medical Center (BIDMC) and GenomeQuest, Inc. (NASDAQ:GQ). The two collaborators are expanding a relationship launched several years ago that involved doing whole genome sequencing of tumors.

More specifically, the expanded relationship will be a two-year collaboration to develop whole-genome analysis (WGA) applications for personalized medicine. The move signals pathologists and clinical laboratory managers that first movers are taking steps to address the growing need for clinical genomics informatics infrastructure.

“The plummeting cost of sequencing and the increasing volume of predictive, public studies makes the clinical application of genomics not just a practicality but a healthcare imperative,” declared GenomeQuest CEO Richard Resnick. “We believe that our collaboration with a combined innovation and delivery leader like BIDMC is a major step forward in expanding genomics and its rewards from the bench to the bedside.” (more…)

Illumina Is Using Acquisitions to Challenge Roche in Fast-growing Market for Gene-based Clinical Pathology Laboratory Testing

Hot competition for genetic testing market share is a signal to medical laboratories to ramp up their molecular and genetic testing capabilities

Financial analysts see something of an “old west” style shootout on the horizon for genetic testing in the clinical laboratory testing market. Market leaders in next-generation gene sequencing are prepared to use acquisitions to build dominant shares in a gene testing market that experts say could hit $25 billion by 2022.

Reporters at Bloomberg Businessweek believe that San Diego-based Illumina, Inc. (NASDAQ: ILMN) is girding up to take on industry giant Roche Holding AG (ROG.VX). Both Illumina and Life Technologies Corp. (NASDAQ:LIFE) are buying up smaller players in the gene testing market.

These two market leaders in DNA sequencing equipment have played important roles in revolutionizing genetic testing. Now, they intend to stake out a share of the fast-growing genetic diagnostics market themselves, a recent Businessweek story reported. (more…)

Doctors’ Mistakes in Genetic Test Orders Is Warning Signal to Pathologists and Clinical Laboratories

Clinical laboratory professionals and pathologists should be aware of significant levels of errors in clinician gene test orders

Almost one-third of medical laboratory test orders for complex gene tests contained mistakes in handling by ordering clinicians. This finding comes from a study by ARUP Laboratories, Inc.. The finding is an early warning flag for pathologists and clinical laboratory professionals that a gap exists between the availability of genetic tests and clinician knowledge of how and when to use them and how to interpret the results. (more…)

Clinical Pathology Laboratories Ignore the Rapid Growth of Mobile Apps in Healthcare at Their Peril

Pathology groups and clinical laboratories have opportunity to use mHealth to add value to clinicians

Experts predict that healthcare’s use of mobile apps—now being described as mHealth—will evolve into a distinct and primary information channel that will play a significant role in clinical care. This includes how anatomic and clinical pathologists use laboratory medicine to support clinical care.

“[M]obile is a technology that winds its way through everything we’re doing and we’re planning to do,” declared Bryan Sivak, Chief Technology Officer at the U.S. Department of Health & Human Services (HHS), in a recent story published in Modern Healthcare (MH).”[It is] a channel to deliver content… a great way for us to collect more real-time information and connect physicians and patients with each other.” (more…)

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