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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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…)

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…)

Sound Wave Acoustic Tweezers Locate and Isolate Circulating Tumor Cells in Liquid Biopsies; Could Lead to Less Invasive Cancer Diagnostics and Treatments

Pathologists will be interested to learn that this latest version of the acoustic tweezer device requires about five hours to identify the CTCs in a sample of blood

Medical laboratory leaders and pathologists are well aware that circulating tumor cells (CTCs) released by primary tumors into the bloodstream are fragile and easily damaged. Many studies have sought to find ways to separate CTCs from surrounding cells. Such a process could then be used as an early-detection biomarker to detect cancer from a sample of blood.

One team of researchers believe it has a way to accomplish this. These researchers are using sound waves to gently detect and isolate CTCs in blood samples. In turn, this could make it possible to diagnose cancer using “liquid biopsies” as opposed to invasive conventional biopsies.

Researchers from Carnegie Mellon University (CMU) in collaboration with researchers from the Massachusetts Institute of Technology (MIT) and Pennsylvania State University (Penn State) have developed a method for using acoustic tweezers and sound waves to separate blood-borne cancer cells from white blood cells. The research team believes this new device could one day replace invasive biopsies, according to a CMU article. (more…)

Researchers at Howard Hughes Medical Institute Develop Blood Test That Reveals a Patient’s Viral History; Could Reduce Unnecessary Clinical Laboratory Testing

The VirScan test gives doctors insight into a patient’s lifetime exposure to viruses and thus may be developed into a useful medical laboratory test

Scientists and pathologists are learning that blood is like a time capsule, holding precious information about exposure to viruses over the years—chickenpox at five, mononucleosis at 18, flu at 40. You get the idea.

Now, researchers at Howard Hughes Medical Institute (HHMI)  have found a way to tap that entire data stream, so to speak. An inexpensive blood test, they say, reveals every virus that has passed through the body over time.

New Discoveries Could Lead to a Useful Clinical Laboratory Test

The testing method, called VirScan by researchers, is an efficient alternative to current medical laboratory tests that test for specific viruses one at a time, according to an HHMI news statement about the new technology. (more…)

British Researchers Working on a Way to Use Cell Phones to Perform Pathology Tests for STDs

Clinical laboratory-on-a-chip would cost under £1 and allow young people to test themselves for sexually-transmitted diseases



Some wags call a new diagnostic testing concept the “pee in the cell phone” pathology lab test. The humor is directed at cell phone-based medical laboratory tests under development in the hopes that this confidential and private diagnostic test method will encourage more young people to undergo testing for sexually-transmitted diseases (STDs).

Newspapers in the United Kingdom are reporting on a research project—funded in part by the government—to develop STD tests that can be run on a USB-size chip that is inserted into a smart phone or a personal computer.

This project is a response to the significant rise in sexually transmitted infections (STIs) among young people. In the United Kingdom, the rate of new infections for herpes, chlamydia and gonorrhea are rising to record levels.

Clinical Laboratory Test on a Cell Phone or Personal Computer

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