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…)

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…)

Genome Sequencing of Tumors Are Helping Pathologist and Physicians Identify Useful Therapies for Patients with Unresponsive Cancers

Early research projects to sequence tumors in clinical settings are helping physicians and pathologists identify mutations that respond to specific therapeutic drugs

Step by step, progress is happening in the use of genome sequencing to advance personalized and precision medicine, with clinical laboratories and pathologists in the forefront of these developments. Much of this effort is focused on cancer and the sequencing of tumors.

One recent example comes from New York City, where the genomes of tumors of patients with unresponsive cancers were sequenced at the Institute for Precision Medicine at Weill Cornell and New York-Presbyterian Hospital Weill Cornell Medical Center. The outcomes of this effort demonstrates how the results of such testing can help patients who had not found an effective therapy to control their cancers. (more…)

;