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 Washington Bioengineers Discover Simple Technique to Use Ordinary Paper for Cheap Point-of-Care Medical Laboratory Tests

This technique transforms ordinary paper into a biofunctional medium that could support a variety of diagnostic tests and lower the cost of clinical laboratory testing

Is the clinical laboratory profession ready for a diagnostic technology that uses ordinary copy paper as the foundation for applying the reagents needed to run any number of fast, portable, accurate, and cheap medical laboratory assays? A recent technology breakthrough may make this possible in just a few years.

A bioengineering team at the University of Washington (UWA) has developed a method to stick medically interesting molecules to ordinary copy machine paper. This “chemical trick” opens the door to developing all sorts of paper-based diagnostic tests that are not just cheap, but virtually free, noted a report published by Fierce Medical Devices. (more…)

Two Different Point-of-Care Test Devices for Malaria Show Why Emerging Technologies Can Be Disruptive to Clinical Pathology Laboratories

Separate research projects at University of Washington and in the United Kingdom are producing handheld diagnostic devices to accurately detect Malaria

Two new handheld, point-of-care test (POC) devices for malaria  could save millions of lives in third-world countries. At the same time, these POC devices may lead to inexpensive alternatives for diagnosing common diseases in developed nations as well.

Clinical laboratory test developers see a big opportunity in developing assays to detect Malaria. That is because an estimated 200 million cases of malaria are diagnosed annually, resulting in the death of about 100 million people each year.

Recently, two organizations released news about the specific testing devices they have developed to detect malaria. One group is at the University of Washington in Seattle, Washington. The other group is NanoMal, a biotechnology company located in the United Kingdom. (more…)

Needle-Free Hematology and Clinical Laboratory Blood Tests May Be Coming Soon to a Point-of-Care Setting Near You!

Researchers say they can see, identify, and count blood cells in vivo, with a system that could eventually move some routine high-volume tests out of centralized medical labs

It would be disruptive to many medical laboratories if routine hematology testing—particularly the traditional complete blood count (CBC)—were to move out of the central clinical laboratory and become a real-time, non-invasive point-of-care test (POCT) that provides the same information that is similar to the traditional complete blood count (CBC).

Israeli researchers developed a microscope with cellular resolution that uses a rainbow of light to image blood cells in vivo as they flow through a microvessel. Experts familiar with the research project say the technology has the potential to find a ready role in clinical diagnostics. (more…)

Sony Makes Sizable Investments in Medical Devices and Clinical Pathology Laboratory Testing

Consumer electronics giant wants to create patient-friendly medical devices and diagnostic kits that will be used in point-of-care settings

Sony is laying groundwork for a major expansion into the world of medical devices, with a particular interest in medical laboratory testing and diagnostic test kits. Experts point to Sony’s new strategy as a sign that prospects in diagnostic testing remain incredibly strong.

Citing unnamed sources, the Israeli business daily Globes printed a story reporting that consumer electronics giant Sony Corporation (NYSE:SNE) is actively seeking to invest hundreds of millions of dollars in Israeli medical technologies.

Confluence of Electronics and Medical Devices Heats Up Sector

This is a major strategy change for Sony and company officials state that Sony will rely less on consumer electronics as it shifts its focus to other sectors, particularly medical devices and clinical diagnostics, in an effort to revive earnings. This was reported in a story reported by Business Week.
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MinuteClinics and Axis-Shield Ink Agreement to Provide Point-of-Care Hemoglobin A1c Tests in 600 CVS Pharmacies

Retail clinics ready to expand into chronic disease management and that can be a threat or an opportunity for clinical laboratories

Dark Daily has often predicted that rapid clinics in retail stores would actively look for opportunities to add specific medical laboratory tests to their on-site service menus. Now the largest retail clinic in the U.S. is set to deploy hemoglobin A1c (HbA1c) testing analyzers in its 600 retail clinic sites throughout the United States.

This deal was announced in November between MinuteClinic, a division of CVS Caremark Corporation (NYSE:CVS), and Axis-Shield plc (LSE:ASD, OSE:ASD), of Dundee, Scotland. The agreement calls for MinuteClinic to use Axis-Shield’s Afinion analyzer in all 600 of its clinic locations across the nation. The system’s HbA1c assay is CLIA-waived. The fully automated analyzer will allow MinuteClinic’s providers to collect a patient specimen and get the results of the hemoglobin A1c tests in as little as three minutes.

Of course, the business strategy here is to add the clinical services necessary so that providers can serve patients with diabetes in these retail clinic settings. This represents a sizeable market. According to the 2011 National Diabetes Fact Sheet, there are 25.8 million adults and children with diabetes, and only 18.8 million have been diagnosed. Of greater interest for clinical laboratory managers and pathologists, 79 million Americans are considered pre-diabetic and, in 2010, 1.9 million new cases of diabetes were diagnosed among individuals who are 20 years and older.
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