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
Sign In

Results of Undercover Assessment Suggest Clinical Laboratory Companies Need to Raise the Bar on Quality Control of Non-Invasive Prenatal Tests

Three out of five NIPT laboratories returned normal or negative test results for samples taken from non-pregnant women in undercover test performance assessment

Clinical laboratory companies that offer genetic tests may want to be on the alert. Secret shoppers are submitting specimens for the purpose of assessing the quality, the accuracy, and the clinical relevance of the proprietary medical laboratory tests they perform.

One such report was published in GenomeWeb under the title “Undercover Assessment of Five Commercial NIPT Labs Points to Need for Better Quality Control.” The goal of the report was to emphasize the need for standards to ensure quality and accuracy of molecular assays and genetic tests.

This report discussed results from an undercover performance assessment of five commercial laboratories, each of which offers Non-Invasive Prenatal Tests (NIPTs). GenomeWeb reported that three test results reported normal or negative test results for a female fetus, despite the fact that the samples submitted had been taken from non-pregnant women. (more…)

The Scientist’s Top 10 Scientific Innovations for 2014 Offer Powerful New Research Tools to Advance Diagnostics and Possibly Find Uses in Clinical Laboratories

Many of these new technologies could help pathologists develop new diagnostic tests and offer medical laboratories opportunities to expand their services

Pathologists and clinical laboratory scientists tracking the hottest new diagnostic technologies may be in interested in the 2014 list of “Top Ten Innovations” recently published by The Scientist.

This is a competition and each year The Scientist has a panel of five experts in life sciences review the entries. Among this year’s Top Ten Innovations are promising diagnostic tools and new technologies with the potential to disrupt the current state of healthcare. In the near future, most of these technologies will be used by researchers to better understand the underlying, genetic cause of diseases and advance new treatments. However, some of these innovative technologies have already been adopted for clinical use. Others are probably several years away from becoming the basis for new medical laboratory tests.

Here is a short overview of The Scientist magazine’s list of “Top Ten Innovations for 2014.” (more…)

Qualcomm TriCorder XPRIZE Selects 10 Finalists: Next Step Is for Devices to Diagnose Patients using Clinical Laboratory Test Technologies and Similar Diagnostic Tools

This new device will likely to be disruptive to clinical laboratories, as it can noninvasively diagnose at least 16 diseases and conditions

Pathologists and clinical laboratory managers who are fans of Star Trek will be interested to learn that a real-life “Tricorder” medical diagnostic device may be just around the corner. Officials of the XPRIZE organization recently announced 10 finalists who are competing to build a working Tricorder capable of monitoring multiple vital signs and identifying specific disease states.

Erik Viirre, M.D., Ph.D., Technical and Medical Director for the Qualcomm Tricorder XPRIZE, announced the 10 finalists last fall. Their devices may have a disruptive impact on medical laboratories, particularly if they lead to inexpensive, self-diagnostic tools that are capable of immediately running most lab tests.

Launched in January 2012 by the XPRIZE Foundation, which organizes international competitions to advance innovation, this life sciences contest to make the tricorder a reality is offering $10 million (£6m) in prize money. (See Dark Daily, “Pathologists and Clinical Lab Scientists: Design a Modern “Tricorder” and You Could Win $10 Million From the XPRIZE Foundation!,” March 22, 2013.) (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…)

New Handheld Imaging Device Can Diagnose Melanoma in Physicians’ Offices, Potentially Reducing the Volume of Skin Biopsies Referred to Pathology Labs

This diagnostic instrument would be preferred by patients and physicians alike because it is noninvasive and provides immediate results

Dermapathologists will be interested to learn about a new handheld, point-of-care (POC) device that images melanoma tumors and enables the in vivo diagnosis of melanoma.

Because this diagnostic technology is noninvasive and provides immediate results, it is likely to be preferred by patients and doctors alike and could thus substantially reduce the volume of skin biopsies referred to dermapathologists and pathology laboratories. (more…)

;