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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University of Pennsylvania Researchers Develop $2 Zika Proof-of-Concept Test That Needs Neither Electricity Nor a Clinical Laboratory to Return Accurate Results

Using 3D printing and a chemical heat source, University of Pennsylvania researchers have created a proof-of-concept for an affordable Zika test that returns results in just 40 minutes

There’s a gap in Zika virus testing that researchers at the University of Pennsylvania hope to fill. That gap is a point-of-care test for the Zika virus that can produce a fast and accurate result, whether in developed nations or in developing countries that don’t have many state-of-the art clinical laboratories.

Although numerous Zika virus tests have earned Emergency Use Authorizations from the US Food and Drug Administration (FDA), gold standard detection is still limited to medical laboratories. To date, the FDA’s list of current and terminated Emergency Use Authorizations include no point-of-care options to help medical professionals quickly screen patients for Zika infection.

As noted by the Center for Disease Control and Prevention’s “Interim Guidance for Interpretation of Zika Antibody Test Results,” the antibodies that indicate Zika virus activity also share similarities with other flavivirus viruses. Of particular note is similarities with Dengue virus—a virus prevalent in many of the areas in which Zika is found. (more…)

IBM and Mount Sinai Researchers Develop Innovative Medical Lab-on-a-Chip Solution

Clinical laboratories and pathology groups may eventually use these devices to detect minute quantities of biomarkers

IBM has regularly declared its interest in being a player in the field of healthcare big data. Now comes news that the information technology giant wants to develop lab-on-a-chip (LOC) technology that can handle different types of clinical laboratory and anatomic pathology tests.

As reported in Nature Nanotechnology, researchers at IBM are working with a team from Mount Sinai Health System. Together, they created a lab-on-a-chip device capable of separating biomolecules as small as 20nm in length from urine, saliva, or blood samples without the need for specialized clinical laboratory equipment. The technology is called nanoDLD.

Current testing of this lab-on-a-chip focuses on exosomes and cancer research. However, researchers note that the asymmetric pillar array on their silicon chip can also separate DNA, viruses, and protein complexes. With further development, they hope to separate particles down to 10nm in length. This would allow isolation of specific proteins. (more…)

Why Healthcare Experts Critical of Direct Access Testing Advise Clinical Laboratories to Take Precautions

Test ordering and results interpretation can confuse the public says Dartmouth Institute, which is why some clinical laboratories limit the types of lab tests that people can request

Giving consumers direct access to medical laboratory testing continues to be a subject of some controversy. One factor in this debate is Theranos, which brought much attention to direct access testing, followed by extensive news coverage in recent months of its problems with reporting accurate clinical laboratory test results.

Concerns about allowing consumers to have direct access to lab testing were the subject of a recent National Public Radio (NPR) Shots Health News story. Several medical experts were interviewed and described why they had concerns about direct access testing (DAT).

One such expert is H. Gilbert Welch, MD, MPH, Professor of Medicine, Community and Family Medicine at The Dartmouth Institute (Dartmouth). According to Welch, DAT could contribute to over-diagnosis and give people an inaccurate impression of what good health actually means. (more…)

Study into Use of Breath Analysis to Monitor Lung Cancer Therapy Enhances Clinical Laboratories’ Ability to Support Precision Medicine

A recent study adds to the growing body of research into breath analysis as a diagnostic and treatment-monitoring tool

More progress is being made on the diagnosis and treatment of lung cancer. The newest developments will be of interest to anatomic pathologists who work with lung specimens. A new study suggests it is possible to use breath specimens to monitor the progress of lung cancer patients undergoing therapy.

The study was conducted by Inbar Nardi-Agmon, MD, Thoracic Cancer Research and Detection Center at Sheba Medical Center, Tel-Aviv, Israel, and colleagues, and was published in the Journal of Thoracic Oncology (JTO). The study investigated the use of breath analysis to monitor lung cancer therapy.

The authors of the study took 143 exhaled breath samples from 39 patients who were undergoing treatment for advanced lung cancer. They used gas chromatography and mass spectrometry analysis to identify three different volatile organic compounds (VOCs) that indicate partial response (PR) or stable disease. One of those compounds discriminated between PR/stable disease and progressive disease. (more…)

Molecular Information Management Systems (MIMS) Are Newest Tools to Help Clinical Laboratories Perform and Report Molecular and Genetic Test Results

Some experts consider MIMS to be the classic LIS on steroids because they are designed to handle the vast amounts of data generated by the latest generation of genetic tests

Steady improvements to next-generation genetic sequencing, lab-on-a-chip technologies, and lab automation are triggering substantial increases in the volume of data generated at medical laboratories and pathology groups. The future of personalized medicine lies just as much in the analysis of the data generated by these tests as it does in how labs perform these procedures.

Laboratory Information Systems (LIS) help to manage and organize much of this data. However, over the past decade, the volume of data generated by molecular and genetic testing has outpaced the organization, reporting, and interfacing features of popular LISs. With more than 3-billion base pairs of DNA in the human genome, each sample analysis has the potential to generate huge amounts of data. (more…)

In 2017, to Offset Declining Reimbursement and Shrinking Budgets, Savvy Clinical Laboratories Are Using LEAN to Improve Service and Intelligently Cut Costs

Nation’s most experienced lab operations managers, cost-cutters, and Lean experts will gather to share successes and proven ideas at Lab Quality Confab on October 18-19, 2016

Most hospitals and health systems are in the first stages of developing their budgets for 2017. Clinical laboratory administrators and pathologists at these institutions report three common factors are driving the next budget cycle: falling reimbursement, flat or declining inpatient admissions, and directives to cut their lab budgets.

“At our health system, the challenge is a bit different,” said one lab administrator at a large Midwest hospital. “Inpatient volumes are increasing, but we get less money from health insurers per admission. For that reason, our budget planning requirement is to accept a smaller budget than last year, while planning to handle more specimen volume in 2017, compared to this year.” (more…)

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