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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Breakthrough DNA Editing Tool May Help Pathologists Develop New Diagnostic Approaches to Identify and Treat the Underlying Causes of Diseases at the Genetic Level

The advent of the CRISPR/Cas9 genetic editing tool is already generating novel therapies for diseases and will create new opportunities for pathologists and medical laboratories

In just 24 months, a new gene-editing tool has become the hot topic worldwide among researchers working to understand DNA and develop ways to manipulate it for therapeutic purposes. It goes by the acronym CRISPR and it may soon become quite familiar to most pathologists and medical laboratory scientists.

CRISPR stands for clustered regularly interspaced short palindromic repeats. The gene editing platform is known as CRISPR/CAS9. (more…)

Study at Boston’s Beth Israel Deaconess Medical Center Determines that 30% of All Clinical Laboratory Tests Are Overused or Medically Unnecessary

BIDMC researchers show that, on average, 30% of all lab tests may be unnecessary and that an equal percentage of tests should not be ordered at all

Every pathologist and clinical laboratory professional knows how often physicians order a medical laboratory test that is inappropriate or unnecessary. That is a problem because, each time a clinician orders an inappropriate test, patient harm is possible. Yet this issue gets little attention from the medical profession at large.

Thus, it is significant that researchers at Beth Israel Deaconess Medical Center (BIDMC), published a study last fall showing that 30% of all medical laboratory tests throughout medicine are overused! A different 30% of medical laboratory tests are underused, as well. (more…)

Predicted Growth for In Vitro Diagnostics Markets Globally Signals Upward Trajectory in Medical Laboratory Business

Growth in global IVD markets is indicator of increasing demand for clinical laboratory and anatomic pathology testing

During the next 24 months, the global in vitro diagnostics (IVD) market is predicted to exceed $50-billion in revenues. However, this robust growth has an upside and a downside for the clinical laboratories and pathology groups that purchase IVD analyzers, reagents, and consumables.

In a recent story in about the IVD industry, Frost & Sullivan, a global consulting and research firm, made predictions in different segments of the IVD market. It won’t surprise pathologists and clinical laboratory managers that the two fastest-growing segments are molecular and tissue diagnostics. (more…)

Proposed Expansion of Screening for HIV and Hepatitis C Could be Good News/Bad News Stories for Clinical Pathology Laboratories

Expanded universal screening would increase costs to the healthcare system; would the healthcare system shortchange clinical labs inadequate reimbursement for the increased number of screening tests?

Separate recommendations that call for widespread, regular screening for HIV and hepatitis C can be considered to be good news/bad news stories for the clinical laboratory testing industry. That’s because the benefits in patient health are likely to incur additional costs for which the healthcare system is not likely to fully reimburse the medical laboratories performing these screening tests.

To improve detection and diagnosis of HIV, a story published in Reuters reported that the U.S. Preventive Services Task Force (USPSTF) will issue a new recommendation to make human immunodeficiency virus (HIV) screening a standard practice. Experts believe that such a strategy would fundamentally change how the virus is detected and treated. (more…)

FDA Panel Recommends Approval for OraSure’s In-Home Consumer HIV Test, Despite Some Concerns about False Positive Results

Sensitivity and specificity of test kit for over-the-counter sale does not equal that of HIV assays performed in licensed and accredited clinical laboratories

Despite concerns about the potential for false positive results, an in-home rapid HIV test kit designed to be sold to consumers in pharmacies and other retail outlets cleared one more hurdle on the path to winning clearance by the Food and Drug Administration (FDA) to come to market.

On May 15, the 17 voting members of FDA’s Blood Products Advisory Committee (BPAC), concluded that the benefits of the OraQuick in-home HIV test outweigh the potential risks for consumers, according to a story published at cbsnews.com. The FDA advisory panel’s decision came despite earlier reported concerns regarding decreased accuracy of the OTC test when performed by consumers as compared to results from the professional-use version.
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