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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Do Some Clinical Laboratory Companies Oversell Prenatal Genetic Screening Tests?

A growing number of media stories claim medical lab companies that develop genetic screening assays oversell the accuracy of such tests and fail to educate parents and doctors about the risks of false positives and false negatives

In response to growing concerns by consumers about the accuracy of some proprietary genetic screening assays, several media outlets have begun reporting on this sector of the clinical laboratory industry.

What gives these news stories emotional punch is the fact that patients use these proprietary medical laboratory tests to make decisions that can be life-changing. In its story about these tests, the Boston Sunday Globe used the headline “Oversold prenatal tests spur some to choose abortions.” (more…)

American Medical Association’s Study of Nation’s 25 Largest Health Insurers Indicates that Biggest Companies Hold Dominant Market Share in Most Regional Markets

Survey results show pathologists and clinical lab managers why largest health insurers have market clout and can exclude local labs from their provider networks

Over the past two decades, ongoing mergers and acquisitions of health insurance organizations have led to ever-greater concentration of market share, even as the number of large health insurance companies has shrunk. One consequence of this trend is that many clinical laboratories and anatomic pathology groups have lost access to managed care patients.

The degree of market concentration will surprise most pathologists and medical laboratory professionals. The concentration of market ownership is clearly demonstrated by the fact that the 25 largest health insurers in the United States now control two-thirds of this $744-billion market. But the largest plans are not necessarily the best, according to 2013 consumer satisfaction surveys conducted by J.D. Power & Associates. (more…)

Researcher at Imperial College London Develops Smart Knife that Allows Surgeons to Detect Cancer In Situ and Without Pathologist Review

Pathologists take note: In one clinical study, diagnostic results produced by a prototype “smart knife” matched postoperative histological diagnosis in 100% of cases

Will a smart knife used in cancer surgery eventually replace the need for a skilled pathologist to diagnose tissue collected during such surgeries?

That’s a question that may be asked in the future if an invention developed at Imperial College London makes it through clinical trials and is accepted for use in patient care. Researchers at Imperial College developed a surgical knife that allows doctors to discern cancer in real-time during surgery—and without consulting with a pathologist.

This invention, dubbed an intelligent knife or iKnife, could be a significant development for clinical laboratory professionals and pathologists if primary research is validated in planned clinical trials.

Pathologists know that when a patient is suspected of having cancer, the current protocols for frozen specimens call for tissue specimens to be sent from the surgical suite to the medical laboratory for analysis. This step may take 20 to 30 minutes.

Meanwhile, the study points out, the patient remains in surgery and under anesthesia. The surgeon waits to learn from the pathologist whether more tissue may need to be removed to ensure that no malignant cells remain in the patient. (more…)

UnitedHealthcare Pushes Back Start Date for Making Claims-Payment Decisions Based on its Florida Pilot Management Program for Medical Laboratory Tests

Health plan sets no new date for BeaconLBS claims-payment decisions but promises 30-days’ notice before making decisions on claims payment

Physicians, pathologists, and clinical laboratories in Florida got a late Christmas present last week. UnitedHealthcare (UHC) (NYSE:UNH) postponed the date when its medical laboratory benefit-management pilot program in Florida, administered by BeaconLBS, would affect claims payments.

This was welcome news, because, beginning January 1, if physicians serving UHC patients had failed to use the BeaconLBS system to obtain pre-notification or pre-authorization for 82 medical laboratory tests, the physicians or labs performing the tests would not be paid by UHC—nor could clinical labs and pathology groups in the UHC provider network bill patients for these tests. (more…)

Major Biobanking Center Planned for Kannapolis, North Carolina, in Tandem with a Multi-Decade Study of the Role of Genetics in Chronic Disease

Pathologists and clinical laboratory scientists may see this research initiative—dubbed the MURDOCK Study—produce knowledge that results in new diagnostic medical lab tests

Can molecular biomarkers do for a North Carolina town what silicon chips did for California’s Silicon Valley? At least one city in the Tar Heel State hopes that it can develop into a major hub for research, development, and the commercialization of molecular science and next-generation gene sequencing.

The unlikely contender pursuing this goal is the city of Kannapolis. With a population of 43,000 and located about 25 miles northwest of Charlotte, the city fathers of Kannopolis appear to be positioning the community as an up-and-coming global center for biobanking. (more…)

Illumina Plans to Tap Consumer Market for its Smartphone-Ready DNA Chip: Will This Create Diagnostic Consulting Opportunities for Pathologists?

Research team at Illumina believes that consumers are ready to access their own gene sequencing data, along with medical lab test data and other diagnostic information

In the field of next-generation gene sequencing, San Diego, California-based Illumina, Inc., (NASDAQ: ILMN) is moving expeditiously to expand into related markets. One such business initiative is to put gene sequencing at the fingertips of consumers via an app and a smartphone.

Although it is expected to take several years to make this feasible, the fact that Illumina is starting to spend money today to serve such a consumer market is a significant fact for pathologists and clinical laboratory executives monitoring developments in the gene sequencing sector.

The company announced plans to develop a chip that plugs into a smartphone and brings genetic medicine to the individual, reported EE Times in a story it published recently. Illumina says it wants to transform smartphones to “molecular stethoscopes” that could eliminate people’s need to visit primary care doctors. (more…)

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