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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Could ‘Money Back’ Guarantees Become More Common for Medical Devices, Clinical Laboratory Tests, and Prescription Drugs as Manufacturers Strive to Prove Clinical Value?

Examples already exist of manufacturers agreeing to refund payments if their therapeutic drugs don’t benefit patients; Medical laboratories with proprietary tests may find this strategy effective at guaranteeing the clinical utility of their assays

If their medical devices, medical laboratory tests, or prescription drugs are not effective, will payers, patients, and doctors get refunds from the manufacturers of these products? Some experts predict that the increased emphasis on improved patient outcomes, and the need for healthcare enterprises to back up the clinical value of their services, could lead to money-back guarantees and reimbursements for treatment therapies.

Offering a refund for services if the patient does not benefit is a powerful and compelling way for a company to call attention to its confidence level in its products and services.     (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…)

Princeton Engineers Develop a Non-invasive Blood Glucose Test that Uses Imaging Technology

If validated in clinical trials, this novel technology has the potential to shift some glucose testing from the clinical laboratory by offering diabetics a convenient, painless blood sugar test

Glucose testing is both a headache and an opportunity for clinical laboratories here in the United States and across the globe. It is a headache because many point-of-care and patient self-test glucose devices in wide use today lack the reliability of glucose testing performed in medical laboratories that use sophisticated diagnostic instruments.

It is an opportunity because, here in the United States and across the globe, there are tens of millions of type 2 diabetics and hundreds of millions of pre-diabetics. Health systems have an unmet demand for glucose testing that is non-invasive, accurate, can be done in patient care settings, and is cheap.

Recently, researchers at Princeton University announced development of noninvasive, in vivo glucose sensor technology that uses a broad-spectrum band of infrared (IR) light to accurately measure blood sugar.

The clinical market for such a device is huge. Just in the United States, there are more than 30 million diagnosed with type 2 diabetes, and more than 70 million pre-diabetics. Researchers have been working for some time to develop a patient-friendly glucose-monitoring technology that does not require a needle stick or venipuncture. (more…)

Nanotechnology-Based Medical Laboratory Test Chip Developed at Stanford University Detects Type-1 Diabetes in Minutes and Can Be Used in Doctors’ Offices

Developers seeking FDA Approval for microchip-based nanotechnology type-1 diabetes test, which has been performed on people with accurate results

New nanotechnology has made it possible for a team at Stanford University School of Medicine to develop a medical laboratory test for type-1 diabetes that can be performed in a physician’s office and does not require a specimen collected by venipuncture.

This microchip requires just minutes to diagnose type-1 diabetes in near-patient settings, according to a Stanford University news release. (more…)

National Institutes of Health Creates Partnership with Big Pharma to Improve Development Success of New Drugs and Diagnostics and Speed FDA Clearance

Pathology groups and clinical laboratories are among the beneficiaries if the Accelerating Medicines Partnership achieves its goals

Power players in healthcare are about to invest nearly a quarter of a billion dollars to accelerate the time it takes for new medical discoveries to gain regulatory approval and enter clinical use. The emphasis will be on both therapeutic drugs and diagnostics, making this an important development for in vitro diagnostics companies and medical laboratories.

Anchors to this new initiative are the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Their partners are 10 pharmaceutical companies and six nonprofit groups. The goal is to jumpstart research to find targets for new drugs and diagnostics, noted a Genomeweb.com article. (more…)

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