Jan 22, 2016 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology
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…)
Sep 9, 2015 | Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
American Gut is using test results to create a microbiome database for use by researchers to better understand how microbes impact human health
Have you ever wondered what lurks in the dark corridors of your bowels? Now you can find out. Two entrepreneurial organizations—one a not-for-profit and the other a new clinical lab company—are charting new medical laboratory territory with the offer of an inexpensive poop test that reveals the type of microbes residing in your gut.
Where to Get Your Gut Microbes Analyzed
The not-for-profit organization American Gut, or British Gut in the United Kingdom (UK), which launched as crowd-funding projects on FundRazr, involve a private research project called the Human Food Project (HFP), which was initiated to compare the microbiomes of populations around the world. The Human Food Project is seeking a better understanding of modern disease by studying the coevolution of humans and their microbes.
People who pay American Gut’s $99 test fee (£75 for the UK project) receive a test kit to collect a stool sample to mail back for DNA sequencing. The test results will be provided to participants, but also benefit microbiome research. (more…)
Nov 26, 2014 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
If validated by additional research, microbiologists, pathologists, and medical laboratory professionals might soon find analysis of the human microbiome to be a useful marker in screening for colon cancer
Microbiologists may play a greater role in the early detection of colorectal cancer, if the findings of a research study at the University of Michigan (UMich) are confirmed with additional clinical studies.
Combining gut microbiome analysis with traditional risk factors for colorectal cancer—such as body mass index (BMI), age, and race—significantly improved the ability of pathologists to distinguish healthy people from those with precancerous or cancerous lesions, wrote researchers from the UMich in a scholarly paper published in the November 2014 issue in Cancer Prevention Research.
Research findings indicate that gut microbiomes may be a major factor in development of colorectal cancer. However, more research is required to determine if this microbial community has the potential to be clinically useful as screening tool for early-stage disease. (more…)
Oct 13, 2014 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News
Seeking ways to improve efficiency and cut costs, labs aim to use less formalin
One seldom-reported development in anatomic pathology is the new priority histology laboratories are giving to employee safety. Labs have long recognized that exposure to the dangerous chemicals used in processing tissue creates risk for histotechnologists.
Today, a rising number of medical laboratories in the United States and other countries are seeking to reduce those risks. Routine chemicals still used today in histology include formalin, toluene, and xylene.
National Cancer Institute Report Lists Formaldehyde as a Carcinogen
In August, a scientific body confirmed the risk of using formaldehyde in the workplace. The National Research Council of the National Academy of Sciences issued a report confirming findings in the 2011 National Toxicology Program (NTP) that listed formaldehyde as a carcinogen. (more…)
May 21, 2014 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Other topics of keen interest at the meeting were digital pathology, whole-slide imaging, and the role of pathology informatics in healthcare ‘big data’
PITTSBURGH, PENNSYLVANIA—During their annual meeting here last week, pathologists who are members of the Association for Pathology Informatics (API) made it clear that they are prepared to support fast and radical changes to anatomic pathology and clinical pathology.
Several speakers called attention to specific threats already disrupting the long-established model of the private pathology group practice. There was also no disagreement that cuts in fee-for-service reimbursement for key anatomic pathology CPT codes were already eroding the financial stability of many pathology practices and pathology lab companies. (more…)
