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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Comparison of In Vitro Diagnostic Industry’s Top Five Trends for 2015 and 2016 Reveals Rapid Technology Advances Intended to Give Clinical Laboratories New Diagnostic Tools

Of the five trends described in a report published by Kalorama, only two made the list for both years: Consolidation within the IVD industry and growth in molecular point of care

What a difference one year can make in the most significant trends influencing the in vitro diagnostics (IVD) industry, which also influences clinical laboratories, the largest customers of IVD manufacturers. These insights come from comparing the top five IVD trends for 2016 as identified by Kalorama Information from its top five IVD trends that it says dominated during 2015.

Kalorama is a division of MarketResearch.com, a company that publishes market research in the life sciences. In a report titled, “Five IVD Market Trends to Watch for in 2016,” it published its picks for the top five trends in IVD testing for 2016. The five most prominent trends recognized by the healthcare research marketer are as follows: (more…)

Innovative Clinical Pathology Laboratories Are Adding Value to Pharmacogenomic Test Reports to Help Physicians Better Interpret and Act upon the Results

There’s even a company called Translational Software providing a service to incorporate enriched information about such tests into the reports that labs deliver to doctors

Personalized medicine is the good news story in healthcare and clinical laboratory medicine today. Armed with new understanding about the human genome, physicians are able to customize therapies for patients that will produce the best outcomes while avoiding or minimizing the negative side effects associated with many common prescription drugs.

This is why pharmacogenomics testing is a booming segment of the clinical laboratory industry. On its website, the Duke Center for Personalized and Precision Medicine describes this emerging lab medicine specialty as follows: “Pharmacogenomic tests are used to inform dosing and predict efficacy and adverse events for therapeutic agents. Most tests involve genetic testing, and in the case of cancer, both the DNA of the host and the tumor can be used to inform the choices for treatment.” (more…)

Health Insurers Balk at Paying for Multigene Panels While Clinical Pathology Laboratories and Physicians Pursue Evidence of Clinical Utility

News reports state that Anthem and Cigna have denied payment for some multigene panel tests, saying that the tests are unproven. Other insurers, such as UnitedHealthcare and Priority Health, pay for such tests but only for certain patients

A conflict is building between patients and health insurers over the reluctance among health plans to pay for new, expensive molecular diagnostic assays and genetic tests that clinical laboratory companies offer.

This conflict has caught the attention of the nation’s media. That is probably because it makes a great story, for example, to interview parents who can assert that their sick child suffered because their health insurance plan would not pay for a genetic test the parents believed would make a difference in their child’s clinical care. Of course, pathologists and medical laboratory professionals know that there are a significant number of expensive genetic tests being offered by various lab companies that lack extensive data to support their clinical efficacy. (more…)

Mathematical Modeling of Systems Pharmacogenetics by Researchers at Penn State May Create New Opportunities for Clinical Pathology Laboratories

Goal is to apply differential equations with pharmacogenomics to better predict a patient’s response to prescription drugs, a development that could create role for pathologists to help clinicians interpret the data from such medical lab testing

New approaches to mathematical modeling are poised to transform pharmaceutical drug research and development—and create new opportunities in clinical laboratory testing down the road. U.S. and Chinese scientists have developed statistical models that more accurately simulate a drug’s reaction in a patient.

Using differential equations, these researchers seek to integrate mathematical modeling of drug reactions into pharmacogenomics. Their goal is to better predict interpersonal differences in drug response based on genetic information. This will help clinicians to develop a strategy for personalized drug delivery. (more…)

World’s First Bedside Genetic Test Provides Results in 60 Minutes without Need to Send Specimen to the Central Pathology Laboratory

Clinical trial demonstrated value of genetic point-of-care testing and a rapid time to result

Here’s a milestone in genetic testing that should catch the attention of pathologists and clinical laboratory managers everywhere. It is a point-of-care (POC) genetic test that is reliable enough to be used in a clinical trial.

The clinical trial was called RAPID GENE. It was conducted at the University of Ottawa Heart Institute (UOHI). The study enrolled 200 patients who were being treated with cardiac stenting for an acute coronary syndrome or stable angina. What made this study unique is that—for the first time in medicine—it used a point-of-care (POC) genetic test. The genetic POCT was used to overcome many previous obstacles that had prevented use of more routine clinical genetic testing.
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