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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Dental Plaque Could Lead to Clinical Laboratory Testing for Biomarkers to Identify Health Risks

Researchers have found that isolating a particular gene within the oral microbiome can reveal a huge amount of useful diagnostic information about a person’s health

Most people don’t think of dental plaque when they think about clinical laboratories. For the vast majority of people, the only diseases that dental plaque bring to mind are those of the mouth:

gingivitis;
periodontitis; and,
dental caries.

Samples that are sent to medical labs and pathology laboratories are more often blood or tissue. However, that could be changing, thanks in part to the work being done at the Oral Microbiome and Metagenomics Research Lab (OMMR) at the University of Toronto. (more…)

Innovative Medical and Pathology Laboratories in Canada Shared Successes in Improving Patient Outcomes at Last Week’s Executive Edge Conference

Pathologists and clinical lab leaders heard about innovations in microbiology automation, genetic testing, use of mass spectrometry, and lab informatics advances

DATELINE: TORONTO, ONTARIO: From across Canada, clinical laboratory executives, pathologists, and health service administrators assembled last week to attend Executive Edge, this nation’s largest conference on innovations in the management and operation of medical laboratories.

Healthcare in Canada faces challenges that are common to healthcare systems in most developed countries. Demand for healthcare is growing at a fast pace due to an aging population and increased incidence of chronic disease. Government budgets cannot grow fast enough to meet the rising demand for healthcare services. (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…)

Obama’s $215 Million Precision Medicine Initiative: Will Congress Fund It and Can It Advance Genetic Testing and the Value of Clinical Laboratory Services?

As proposed, the President’s Precision Medicine Initiative would incorporate a large, volunteer study cohort in innovative ways

Even as a new presidential initiative to boost precision medicine makes headlines, there is uncertainty as to how the program can be funded. The Precision Medicine Initiative was announced by President Obama on January 30, 2015.

Many pathologists, clinical chemists, and medical laboratory scientists recognize that such a program would pump additional funds into the research and development of new diagnostic tests that are designed to aid physicians in their practice of precision medicine.

The big question is how to pay for this initiative. President Obama proposed budgeting $215 million to fund this effort. But such funding must be approved by a Congress that is at odds with the President on nearly every issue. Additionally, The American Clinical Laboratory Association (ACLA) warns that the Food and Drug administration’s (FDA) 2014 announcement to regulate laboratory developed testing services (LDTs) is in conflict with the President’s initiative. (more…)

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