This low-cost solution opens new doors for low-resource regions and, in many cases, allows operators to rule out malignancy without the need for a pathologist to review biopsies
Rapid development of endoscopic technologies is bringing medical professionals closer to point-of-care pathology than ever before. The goal is to allow physicians to identify diseased or cancerous tissue in situ and reduce or eliminate the need to biopsy tissue for examination by surgical pathologists.
Researchers at Rice University in Houston are developing a high-resolution microendoscope (HRME) that offers the ability to view tissue at a subcellular level. This fiber optic probe would reduce the need to collect the biopsy that is typically sent to anatomic pathologists for analysis.
Measuring 1-mm in diameter, the probe works using the existing accessory channel of the endoscope. Touching it to the surface of the tissue provides real-time in vivo images to the technician at up to 12 frames per second on an accompanying tablet display. Images are enhanced using visual overlays and an algorithm that highlights the nuclei of cells within the field of view. The HRME system is battery powered and fits in a briefcase for easy transport. (more…)
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…)
Team of bioengineers succeeds in putting three different imaging technologies into a handheld probe that could be used by physicians to assess skin lesions in their offices
Dermatopathologists and pathology practice administrators will be keenly interested in a new, hand-held diagnostic device that is designed to reduce the need for skin biopsies. Because of high volume of skin biopsies referred to pathologists, any significant reduction in the number of such case referrals would have negative revenue impact on medical laboratories that process and diagnose these specimens.
This innovative work was done at the University of Texas at Austin’s Cockrell School of Engineering. The research team developed a probe that uses three different light modalities to detect melanoma and other skin cancer lesions in real-time, according to a news release.
Extraneous tissue cross-contamination found in all participating pathology laboratories Cross-tissue contamination, regardless of specimen volume or how frequently reagents were changed
Pathologists and histotechnologists have long known that traditional methods of processing tissue for diagnosis have the potential to cross-contaminate human biopsy specimens. This risk to patient safety and diagnostic accuracy was accepted over the decades because of the limitations of technology and inability to more precisely measure the performance of individual work processes in the histology laboratory.
In recent years, two things have begun to change this long-standing status quo in medical laboratories. These developments now make it possible to more accurately measure the performance of histology work processes. In turn, this allows an understanding of the true rate of errors that happen from the time a human biopsy specimen arrives in the anatomic pathology laboratory until the completed slides are ready to be diagnosed by a pathologist. (more…)
New technology could reduce or even eliminate the need for clinical pathology laboratories to utilize tissue biopsies in the diagnosis of certain cancers
“Cancer flashlight” is the nickname some have given to a system that uses novel spectroscopic techniques to detect pre-cancerous cells in the colon. Developed by bioengineers at Duke University, the device may offer an alternative to current biopsy methods for detecting cancer and pre-cancer by anatomic pathologists.
The new technology may be a way to detect abnormal, dysplastic cells in the epithelium of various tissues in a non-invasive way, wrote The Atlantic in a story it recently published. The Atlantic thinks this technology breakthrough may be significant because approximately 85% of all cancers begin within the layers of the epithelium in various parts of the body.