Apr 25, 2016 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing
Legislation has been introduced that, if passed, would ensure health consumers have the opportunity to see and correct information held by data brokers
When it comes to patient privacy, pathologists and clinical laboratory managers may be spending more time addressing a growing issue with the patient data their labs create and store. Third-party data brokers want to position themselves to collect healthcare data at the source so can they de-identify it and sell it to interested parties.
Data brokers are commercial entities that collect, assemble, and/or maintain personal information about individuals. They also sell or provide third-party access to the information, explained the Congressional Research Service, a Legislative Branch Agency that provides policy and legal analysis to both House and Senate members and committees of the U.S. Congress, regardless of party affiliation.
Pharmaceutical companies, medical device manufacturers, and other businesses can purchase said data from various types of data brokers, such as information, analysis, and technology companies. The purchased data then can go on to guide industry investments or launch drug marketing campaigns. (more…)
Feb 17, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing
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…)
Nov 13, 2015 | Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Lab-on-a-chip technology could reduce the time needed to identify infection-causing bacteria and for physicians to prescribe correct antibiotics
Pathology groups and medical laboratories may see their role in the patient-care process grow if researchers succeed in developing culture-independent diagnostic tools that quickly identify bacterial infections as well as pinpoint the antibiotics needed to treat them.
In the battle against antibiotic-resistant infections (AKA “super bugs”) the National Institutes of Health (NIH) is funding nine research projects aimed at thwarting the growing problem of life-threatening infections that no longer are controlled or killed by today’s arsenal of drugs.
Common Practices in Hospitals Leading to Super Bugs
Currently, when infections are suspected in hospitals or other settings where illness can quickly spread, samples are sent to a central medical laboratory where it may take up to three days to determine what germ is causing the infection. Because of that delay, physicians often prescribe broad-spectrum antibiotics based on a patient’s symptoms rather than lab test results, a practice that can lead to the growth of antibiotic-resistant microbes. (more…)
Oct 9, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Houston newspaper breaks story about failure of many medical laboratories to report certain test results to public health laboratories, thus delaying investigations of disease outbreaks
Once again, problems with the existing system of medical laboratory testing made national news. This time, the key players were a maker of ice cream, clinical laboratories, and public health laboratories.
It was a Houston newspaper that first reported a pattern of failures in how clinical laboratories and public health laboratories communicate as clinical labs identify patients who tested positive for listeriosis, a bacterial infection most commonly caused by Listeria monocytogenes. These test results were associated with the recent listeriosis outbreak that was connected to Blue Bell ice cream.
Blue Bell, Listeria, and Lab Failures
On July 18, 2015, the Houston Chronicle reported on David Philip Shockley. He is a retirement community administrator who believes he contracted listeriosis by eating Blue Bell ice cream. (more…)
Sep 25, 2015 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
Researchers are concerned about the lesser-known genes included in the test and also point out that little published research exists to support use of these genes for clinical laboratory testing
Gene-panel tests for inherited cancers were scrutinized by a group of 17 prominent international genetic researchers in a study published by the New England Journal of Medicine (NEJM) this summer titled “Gene-Panel Sequencing and the Prediction of Breast-Cancer Risk.” These experts pointed out that, for many of the genes included in these test panels, there remains much uncertainty about their role in various cancers and other diseases.
What will be of greatest interest to pathologist, Ph.D.s, and medical laboratory professionals currently performing molecular diagnostics assays and genetics is that these experts proposed greater regulation of unvalidated gene-panel tests for inherited cancers. In the NEJM, the authors provided some examples of genetic tests, such as those offered by Myriad Genetics, Inc. (NASDAQ:MYGN), Ambry Genetics, Invitae (NYSE:NVTA), and Illumina, Inc. (NASDAQ:ILMN) and noted that risks posed by many mutations occurring on these panels are unknown.
These panel tests can include more than 100 genes, 21 of which are an indication of breast cancer, including BRCA1 and BRCA2, stated the paper. (more…)
