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

Comparison of In Vitro Diagnostic Industry’s Top Five Trends for 2015 and 2016 Reveals Rapid Technology Advances Intended to Give Clinical Laboratories New Diagnostic Tools

Of the five trends described in a report published by Kalorama, only two made the list for both years: Consolidation within the IVD industry and growth in molecular point of care

What a difference one year can make in the most significant trends influencing the in vitro diagnostics (IVD) industry, which also influences clinical laboratories, the largest customers of IVD manufacturers. These insights come from comparing the top five IVD trends for 2016 as identified by Kalorama Information from its top five IVD trends that it says dominated during 2015.

Kalorama is a division of MarketResearch.com, a company that publishes market research in the life sciences. In a report titled, “Five IVD Market Trends to Watch for in 2016,” it published its picks for the top five trends in IVD testing for 2016. The five most prominent trends recognized by the healthcare research marketer are as follows: (more…)

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…)

Home-testing IVD Diagnostic Devices Win Rigorous MDEA Design Awards as Part of Ongoing Trend to Move Medical Laboratory Tests Closer to Patient

Innovative designs promote in vitro home-testing medical diagnostic devices that could impact the work done in clinical laboratories

With greater frequency, new diagnostic technologies make it possible to move medical laboratory tests out of the traditional central lab facility and closer to the patient—including patient home self-testing. Even as this happens, engineers and designers are delivering elegant, well-designed devices designed for use in clinical laboratories as well as in near-patient settings.

Evidence of this trend comes from the most recent winners in the annual contest known as the Medical Device Excellence Awards (MDEA). In this year’s contest, two of the products receiving awards were medical laboratory test devices that were deemed to be innovative solutions to improve the lab testing process.

This contest intends to “recognize significant advances in medical product design and engineering that improve the quality of healthcare delivery and accessibility.” The competition was first held in 1998 and is sometimes described as the “Oscars” of the medical device. Receiving an MDEA medal offers validation, publicity, and a host of other benefits. (more…)

Medical Scientists Call for Standard Method for Validating Antibodies Used in Research and Clinical Laboratory Diagnostics

Antibody validation standards would help ensure reproducibility of research studies and improve the consistency medical laboratory test results

As science and industry gets better at measuring things and assessing quality, the acceptable standard often comes into question. This seems to be happening with antibodies, the most common reagents used in diagnostics, clinical laboratory diagnostic tests, and medical research. In many cases, the end result is that companies and their suppliers must use new technologies and quality methods to revise the “old way” and create products that have measurable better quality.

The techniques currently used to validate antibodies is the topic of a recently-published scientific paper. The authors of a paper published in the March, 2010, issue of Biotechniques pointed out, antibody validation and standardization ensure study reproducibility, which is critical to accuracy. And yet, no standard guidelines define how these important biological tools should be validated prior to use.

Thus, researchers participating in a recent webinar, presented by The Scientist expressed concern that—without improved antibody validation and standardization—the accuracy of published research is in question and diagnostic test results, such as those produced by medical laboratories, will continue to be inconsistent. (more…)

Synthetic Biologists Demonstrate Ability to Rapidly Create Cheap, Accurate In Vitro Diagnostics Tests That Could Eventually Help Pathologists Diagnose Disease

Wyss Institute develops prototype Ebola test in less than 12 hours with $20 in materials, perhaps paving the way for inexpensive paper-based diagnostic tests with a wide range of applications outside the medical laboratory

One goal of many synthetic biology researchers is to create in vitro diagnostic testing systems that produce results that are as accurate as those produced in today’s state-of-the-art clinical laboratories, yet are much cheaper to run because they incorporate low-cost materials, such as paper.

Recently, two teams of researchers worked to demonstrate how several synthetic biology methods, when combined with programmable paper-based diagnostic platform, could detect antibiotic-resistant bacteria and strain-specific Ebola virus. These findings were published in a peer-reviewed medical journal last fall.

Such cell-free circuits embedded in paper could be the breakthrough in synthetic biology that leads to pocketsize blotter tests that can detect such diseases as Ebola in the field.  Should this line of research be applied to clinical settings, pathologists and medical laboratory scientists could soon be processing bandages that change colors in the presence of certain bacteria, or examining paper-based clothing infused with diagnostic laboratory tests that react to bio-markers specific to a chronic disease patient’s condition. (more…)

;