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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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…)

New Medical Laboratory-in-a-Suitcase Detects Ebola in 15 Minutes or Less

Demand for a rapid, accurate diagnostic solution to combat Ebola is motivating research teams in many countries to develop solutions that can be put to immediate use

In West Africa, the outbreak of Ebola in several countries motivated researchers in Germany to develop a fast, accurate, and inexpensive test that could be performed in patient care settings without the need for a centralized medical laboratory.

In these West African countries, lack of electricity and reliable cold storage or diagnostic equipment handicaps clinical laboratory technicians who are testing patients for the Ebola virus. A new test developed by researchers at the German Primate Center (DPZ) in Göttingen, Germany, cuts the time to answer an Ebola diagnosis to just 15 minutes. It requires no electricity and is portable. Previously, the fastest Ebola diagnostics test took three hours to get results and required transporting samples to often-distant medical laboratories. (more…)

‘Genetic Testing Handbook’ Provides Physicians, Pathologists, and Clinical Lab Managers with Comprehensive Reference for Clinical Genome and Exome Sequencing

This new tool offers clinicians the dos and don’ts of genetic testing, what physicians need to know to do it properly 

Clinical use of gene sequencing information has advanced to the point where a team of genetic experts has compiled and issued the Genetic Testing Handbook. The goal of the clinical genome and exome sequencing (CGES) handbook is to provide clinicians—including pathologists and clinical laboratory scientists—with a useful reference tool.

The authors of the Genetic Testing Handbook are Leslie G. Biesecker, M.D., of the National Human Genome Research Institute (NHGRI) in Bethesda, Maryland, and Robert C. Green, M.D., M.P.H., a geneticist who is an Associate Professor of Medicine at Harvard Medical School.

Primer Distills Human Genome Project Technologies for Practical Use

“The technologies that were used for the Human Genome Project are now distilled down to practical tools that clinicians can use to diagnose and, hopefully, treat diseases in patients that they couldn’t treat before,” stated Biesecker, who serves as Chief and Senior Investigator at the NHGRI’s Medical Genomics and Metabolic Genetics Branch, in a press release issued by the National Institutes of Health (NIH). (more…)

23andMe and Udacity Launch ‘Massive Online Open Course’ in Human Genetics

Innovative web-based educational formats might add value to training initiatives for pathology residents and fellows and medical laboratory workers

In the final months of 2013, the regulatory fight between gene testing company 23andMe.com and the Food and Drug Administration (FDA) generated national headlines. In that encounter, 23andMe.com blinked and ceased offering health-related genetic tests to consumers.

However, the company continues to work to position itself as a major player in genetic testing and genetic medicine. In the second half of 2013, for example, 23andMe.com initiated a business campaign to position itself as a source of on-line information about genetics for educational purposes. (more…)

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