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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New Miniature Continuous Glucose Monitoring Devices from DexCom and Verily (Google Life Sciences) Promise to Make Glucose Monitoring Wearable and Affordable

Such a small, non-invasive glucose monitor would capture and transmit data to the Cloud, making it feasible for clinical laboratories to collect those tests results, and keep a record of each patient’s glucose results

Probably no single area of medical laboratory testing has the greatest potential to help the largest number of patients with a chronic disease—and make a lot of money for the in vitro (IVD) manufacturer who is first to market with the right diagnostic product—than glucose testing and continuous glucose monitoring (CGM). Pathologists and clinical laboratory managers know why this is true.

Reports from the Centers for Disease Control and Prevention (CDC) and the American Diabetes Association, state that more than 29 million Americans (about 9% of the U.S. population) have diabetes. Nearly 28% of these (about eight million) are undiagnosed. The reports also stipulate that fasting glucose or A1C levels have shown that more than 80 million people over the age of 20 were prediabetic in 2012. Based on trends since then, we can safely assume that the number of prediabetics in America has grown. And what is true in the United States is general true in most developed nations throughout the world. (more…)

Researchers at University of Rhode Island Unveil Lab-on-Paper Test Capable of Multireagent Diagnostics: Could Enable ‘Diagnostics Without the Lab’ say Developers

New diagnostic capabilities could enable clinical laboratories to obtain multiple outcomes on single fluidic strip tests

Researchers at the University of Rhode Island (URI) have developed a paper-based microfluidic valve technology that some claim may revolutionize existing lateral-flow tests. There is the potential for this innovation to eventually enable pathology groups and medical laboratories to conduct a wide variety of complex medical diagnostics on single fluidic test strips, such as those used to diagnose pregnancy and strep throat, according to a university statement.

Testing Multiple Biomarkers Using a Single Test Strip

Fluidic test strips commonly in use today are generally capable of rendering only one result. However, by combining their new paper-based valve platform with standards strip tests, the URI research team has produced strip tests capable of answering more challenging medical questions.

The evolution of the new technology, dubbed “Lab-on-Paper,” follows the development of the team’s earlier “lab-on-a-chip” device, which the researchers began developing back in 2005. (more…)

Cleveland Clinic Gives Patients Statewide 24/7 Access to Physicians through Smartphones, iPads, Tablets and Online: Will Telemedicine Also Involve Pathologists?

New service allows patients statewide to access urgent care via telephones and other devices as Cleveland Clinic positions itself to be a 24/7 provider of choice

Urgent care by telephone is the latest patient-centric and customer-friendly medical service to be offered by the Cleveland Clinic. It is also the first 24-hour online statewide healthcare service of its kind in Ohio, a milestone that has implications for pathologists and clinical laboratory executives because lab testing is often required in support of patients wanting access to urgent care, particularly after hours.

Express Care Online (formerly MyCare Online) is the Cleveland Clinic’s new telemedicine service. It enables patients to see a medical professional for urgent matters via computer or smartphone 24 hours a day/seven days a week, according to a Cleveland Clinic statement. (more…)

More Companies Pay for Employees to Have Genetic Tests in a Trend That Brings More Lab Test Volume to Medical Laboratories

As tests explore genetic markers related to excessive weight gain, and breast and ovarian cancer, companies as well as employees are seeing returns on investment and participation

In a development that is auspicious for medical laboratories, more genetic tests are making their way into more corporate health benefit plans. Big brands—from Aetna to Visa—are partnering with personalized health companies and clinical lab companies doing genetic testing as they support tests to help employees head-off health risks.

Employers’ sponsorship of genetic testing is a trend that could become more common, noted Fortune. But human resources and benefits experts say the offerings are still uncommon. There are also unresolved issues, such as when genetic test results are inconclusive or questionable.

For medical laboratories, the companies’ genetic testing benefits could prompt more test orders from healthcare consumers. Based on the results of their genetic tests, people might decide to make lifestyle changes, work toward prevention of chronic conditions, and take further tests to assess progress. (more…)

Pigeons as Anatomic Pathologists? Researchers at University of Iowa and UC Davis Train Pigeons to Identify Cancerous Cells from Healthy Cells in Human Breast Tissue

Studies at the two universities produced intriguing insights into the ability of pigeons to discriminate between benign and malignant breast cancer slides at all magnifications

Researchers at the University of Iowa and the University of California Davis (UC Davis) are reporting intriguing results from a study indicating that pigeons have the potential to be “proficient pathologists” when it comes to telling the difference between healthy and cancerous cells in human breast tissue.

With minimal training and food reinforcement, the common pigeon or rock dove, performed as well as humans at identifying and classifying (AKA, pigeonholing) digitized slides and mammograms of benign and malignant human breast tissue, stated the researchers. (more…)

Attention Pathologists! New Prostate Cancer Test Has CPT Code, NCCN Guideline Recommendation, and Potential Market of One Million Prostate Biopsies Annually

OPKO Health’s 4Kscore test predicts the rate of high-risk prostate cancer and may become a useful business case study for other labs developing proprietary diagnostic tests

Clinical laboratories and biotech companies with new medical laboratory tests are struggling to win coverage by Medicare and private payers. How big is this problem? There are currently tens of thousands of molecular diagnostic assays and genetic tests offered for clinical use.

Any lab company seeking to obtain an appropriate Current Procedural Terminology (CPT) code, favorable coverage guidelines, and adequate reimbursement from health insurers for its new lab test faces three big challenges, and they are related. First, payers are simply overwhelmed with requests to review new genetic tests. The flood of new test submissions exceeds the capability of payers to respond.

Most Payers May Not Have Right Scientific Expertise to Evaluate Genetic Tests

Second, most health insurance plans lack physicians and medical professionals who have the necessary experience in laboratory medicine, molecular diagnostics, and genetic medicine to evaluate these lab test submissions in a knowledgeable way. (more…)

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