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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Strata Oncology, in Tandem with Thermo Fisher, Offers 100,000 Free Genetic Cancer Tests to Patients as Part of New Clinical Laboratory Business Model

Startup medical company proposes to offer free genetic testing to 100,000 advanced cancer patients to increase their chances for optimum therapeutic results

Strata Oncology (Strata), a precision medicine company based in Ann Arbor, Mich., plans to provide free genetic testing to advanced cancer patients beginning in 2017. The company raised $12-million dollars and teamed up with Thermo Fisher Scientific to complete the large-scale tumor sequencing project.

Using tumor tissue, Strata’s gene test sequences DNA and RNA to identify patients with certain gene mutations. This information is used to determine which cancer medications would be best for each patient. Patients are then referred to the appropriate pharmaceutical company for drug therapy and, potentially, for customized clinical trials.

Strata states on their website that their goal is to “dramatically expand late-stage cancer patients’ access to tumor sequencing and precision medicine trials, and to accelerate the approval and availability of breakthrough cancer medicines.” (more…)

How Price Transparency Caused Patients to Gripe Loudly about the Skyrocketing Cost of Mylan’s EpiPen and Why Clinical Laboratories Should Watch Next Developments

Medical laboratory managers are getting an important lesson in the power of price transparency to motivate patients to complain about arbitrarily high prices for healthcare services and products

By now, most clinical laboratory managers and pathologists know about the EpiPen pricing scandal. Simply said, it illustrates all the flaws and problems in the US healthcare system that make it possible for vendors and providers to raise prices arbitrarily and stick the bill on health insurers, employers, and patients.

However, it was one change in the healthcare system that caused the outrageous pricing strategy of EpiPen’s manufacturer, Mylan Inc., to become national news: price transparency for patients. That change is a result of the increased number of patients who must pay high deductibles and co-pays as a requirement of their health insurance plan. Thus, because tens of millions of patients were forced to pay for most or all of the cost of EpiPens, it was their complaints about the high cost of this device that brought the story to the attention of the national news media. (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…)

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