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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Whole Human Gene Sequencing Technology Is Poised to Be the Next Big Thing for Clinical Pathology Laboratories

Smaller, more affordable sequencers and genome sequence interpretation computers are catching the interest of pathologists and medical laboratory scientists

In the field of whole human genome sequencing, the technology continues to improve at a remarkable pace. Products now entering the research and clinical marketplace offer speedier, more accurate gene sequencing capabilities at prices that are within the budget reach of many clinical laboratories and anatomic pathology group practices.

Miniaturization and lower cost is driving genomic medicine ever closer to the routine clinical setting. The combination of next generation gene sequencers with a smaller footprint and advances in genomic data analysis technology mean that genomic testing will increasingly migrate to smaller lab settings. Dark Daily offers its readers a look at some of the latest gene sequencing products and what their manufacturers say about the capabilities of these gene-sequencing systems. (more…)

In Boston this week, the Association of Pathology Chairs Looks at Healthcare’s Transformation and How It May Reshape Laboratory Medicine

Departments of pathology and clinical laboratory medicine at nation’s academic medical centers are uniquely positioned to deliver value—but only if they act in a timely fashion

DATELINE: BOSTON, MASSACHUSETTS—Today the Association of Pathology Chairs (APC) concluded its annual meeting, and transformation of the U.S. healthcare systems was front and center as the topic of primary interest. This transformation presents pathology departments at the nation’s academic centers with a range of unique opportunities, along with some serious challenges.

On the upside, academic departments of pathology and clinical laboratory medicine are well positioned to be the leaders in clinical diagnostics that utilize the latest genetic knowledge and incorporate state-of-the-art molecular technologies. Not only are they teaching this knew knowledge to the next generation of physicians and pathologists, they are often the only locally based laboratory organization in a city or region that offers these advanced medical laboratory testing services. (more…)

California’s New Health Insurance Exchange May be Unexpectedly Low, but Co-pays for Outpatient Services Are Relatively High

High Co-pays for Lab Tests May Create a Collection Nightmare for Clinical Laboratories
As new facts about the prices of premiums and the amount of patient co-pays for California’s health information exchange—called Covered California—are published, the news is not likely to be favorable for clinical laboratories and anatomic pathology groups in the Golden State.

Of particular note is that Covered California has published a requirement that patients will be charged a $35 co-pay for medical laboratory testing. Some lab industry executives have pointed out that it will be a challenge to collect these co-pays. They expect labs will incur higher costs attempting to collect these co-pays while at the same time seeing a substantial increase in levels of bad debt. However, all of this will not happen until 2014, when Covered California begins providing health insurance coverage.

For one category of insured beneficiaries, there is a bit of good news. Insurance exchange premiums for individuals not covered by employer health plans will be lower than previously expected. Covered California will charge, on average, $321 per month on average for the “Silver,” medium-tier plan, noted Peter V. Lee, Executive Director of Covered California, in a report published by the Wall Street Journal. (more…)

Two Different Point-of-Care Test Devices for Malaria Show Why Emerging Technologies Can Be Disruptive to Clinical Pathology Laboratories

Separate research projects at University of Washington and in the United Kingdom are producing handheld diagnostic devices to accurately detect Malaria

Two new handheld, point-of-care test (POC) devices for malaria  could save millions of lives in third-world countries. At the same time, these POC devices may lead to inexpensive alternatives for diagnosing common diseases in developed nations as well.

Clinical laboratory test developers see a big opportunity in developing assays to detect Malaria. That is because an estimated 200 million cases of malaria are diagnosed annually, resulting in the death of about 100 million people each year.

Recently, two organizations released news about the specific testing devices they have developed to detect malaria. One group is at the University of Washington in Seattle, Washington. The other group is NanoMal, a biotechnology company located in the United Kingdom. (more…)

University of Michigan Study Predicts that Majority of Physician Practices Will Lose Money on their EHR Systems

Research study shows opportunity for clinical laboratories to help client physicians get more value from their electronic health record systems

For the majority of physicians in the United States, implementation of an electronic health record (EHRs) system in their practice may turn out to be a money-losing proposition. That is one prediction made by researchers at the University of Michigan (UM), based on a study they conducted.

Among other things, these findings indicate that progressive clinical laboratories and pathology groups have the opportunity to leverage the interface between their laboratory information system (LIS) and the client physician’s EHR to deliver added value. That’s because pathologists, Ph.D.s, and laboratory scientists know many ways that physicians can improve how they order medical laboratory tests and act upon the results of those tests.

(more…)

Clinical Pathology Laboratories File Petition Against Threat of Regulation of Laboratory-Developed Tests

FDA intends to pursue regulation of laboratory-developed tests (LDTs) as medical devices, according to FDA Commissioner Hamburg

FDA regulation of laboratory-developed tests (LDTs) is getting attention again. In recent weeks, FDA Commissioner Margaret Hamburg, M.D. put the clinical laboratory industry on notice that the commission intends to pursue regulation of LDTs.

Pathologists and clinical laboratory scientists have long used LDTs to solve clinical diagnostic problems and as a way to use new technologies to address unmet clinical challenges. As a result, these medical laboratory tests are critically important to the growth of personalized medicine. (more…)

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