Jun 15, 2016 | Compliance, Legal, and Malpractice, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
The decision means Walgreens will no longer offer Theranos blood-collection services at any of its stores, a move that is expected to cut Theranos’ income sharply because the lab testing company would no longer have a significant source of medical laboratory test volume
Walgreens Boots Alliance (NASDAQ:WBA) is ending its relationship with Theranos Inc. and closing all 40 Theranos Wellness Centers at its stores in Arizona, effective immediately, the national pharmacy chain store company announced on Sunday, June 12. It means that Theranos will no longer be able to collect medical laboratory specimens at pharmacies owned by Walgreens.
This move follows a decision by Walgreens in January that Theranos could no longer send clinical laboratory tests collected at Walgreen’s Wellness Centers to the Theranos lab in Newark, Calif. In the fall, the federal Centers for Medicare and Medicaid Services (CMS) cited the Newark lab as the source of serious deficiencies that risked patient harm, CMS said. (See Dark Daily, “CMS Notifies Theranos of CLIA Sanctions That Include Revoking Clinical Laboratory’s CLIA License and a Two-Year Ban on Holmes, Balwani, and Dhawan,” April 14, 2016.) (more…)
Jun 6, 2016 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Utah-based Tute Genomics and UNIConnect will partner with Newborn Screening Ontario to uncover rare but treatable diseases in newborns
In the Canadian province of Ontario, next-generation gene sequencing will soon be part of newborn screening. This development is another confirmation for clinical laboratory managers and pathologists that genetic information from such diagnostic testing is contributing to improvements in clinical care.
Newborn Screening Ontario (NSO) is teaming up with Tute Genomics of Provo, Utah, and UNIConnect of Sandy, Utah, to enhance the province’s testing program for rare but treatable diseases in newborns.
The Ontario Ministry of Health and Long-Term Care is contracting with NSO to offer a next-generation sequencing testing panel and a multiple ligation-dependent probe amplification assay for the diagnostic confirmation of a variety of disorders. (more…)
May 27, 2016 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Understanding the unknown functions of these genes may lead to the creation of new diagnostic tests for clinical laboratories and anatomic pathology groups
Once again, J. Craig Venter, PhD, is charting new ground in gene sequencing and genomic science. This time his research team has built upon the first synthetic cell they created in 2010 to build a more sophisticated synthetic cell. Their findings from this work may give pathologists and medical laboratory scientists new tools to diagnose disease.
Recently the research team at the J. Craig Venter Institute (JCVI) and Synthetic Genomics, Inc. (SGI) published their latest findings. Among the things they learned is that science still does not understand the functions of about a third of the genes required for their synthetic cells to function. (more…)
May 25, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Blood genotyping is one type of DNA test this miniature lab can perform as entrepreneurs work to take DNA testing out of medical laboratories and into other settings
It had to happen! There’s now a product designed to allow individuals to perform “do-it-yourself” DNA testing. Pathologists and clinical laboratory managers will be interested to learn that—for less than $800—they can acquire their own home set-up, which includes a PCR thermocycler, a centrifuge, a gel electrophoresis box, and a power supply with blue LED transillumination.
This new, compact, deoxyribonucleic acid (DNA) analysis product was developed to give individuals who want to work with DNA a fun and easy way to explore their genetic make-up.
It was developed by Bento Bioworks, a company based in London, England, and is described as a do-it-yourself DNA analysis kit called Bento Lab. The device is about the size of a laptop computer and may be used anywhere to conduct a variety of DNA experiments.
Bento Lab allows people to conduct simple DNA tests from samples obtained from saliva or hair follicles. Animal tissue, food, and drink samples may also be evaluated with the unit.
To perform an experiment, the user simply places a sample into a centrifuge located in the middle of the device. Bento Lab then extracts the DNA for analysis and a thermocycler targets a specific portion of the DNA and copies it. A gel unit then portrays the DNA to enable the user to interpret the results. (more…)
May 18, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology, Laboratory Testing
As technologies used by fitness wearables mature, medical laboratories will want to develop ways to access and process the flood of data that will become available
Point-of-care testing and remote patient monitoring are two technologies that could be disruptive to the clinical laboratory industry, particularly if use of these devices was to reduce the volume of patient specimen that are referred to the nation’s large, centralized medical laboratories.
This is one reason why savvy pathologists watch the stream of new products designed to allow athletes and consumers to monitor their fitness and other characteristics of good health. These devices are at the very front of the curve for remote monitoring of an athlete’s performance during training and competition, as well as enabling consumers to track different parameters of their health. What’s a toy for today’s sophisticated consumers could later be easily adopted for clinical diagnostic purposes.
One great example of how swiftly technology advances are changing remote diagnostic monitoring involves heart rate monitors. It wasn’t long ago that even basic heart rate monitors were a pricey purchase for consumers. But thanks to strong interest in gathering healthcare data, costs are dropping. (more…)
May 4, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
The Wall Street Journal examines the FDA’s position on LDTs and looks at the pros and cons of LDT regulation by the federal agency
National news coverage over the deficiencies uncovered by Clinical Laboratory Improvement Amendments (CLIA) inspections of the clinical laboratory operated by Theranos in Newark, Calif., may have an interesting consequence that affects all medical laboratories and pathology groups.
Over the past 30 months, Theranos has regularly asserted that its laboratory-developed tests (LDTs) were under review by the Food and Drug Administration (FDA). For example, in an interview published in the December 14, 2014, issue of The New Yorker, Theranos Founder and CEO Elizabeth Holmes stated, “We believe that to realize our vision we must operate at the highest levels of excellence… And the FDA’s stamp of approval is seen as an indicator of the quality of a product.”
Thus, it would be ironic if the problems in the quality of clinical laboratory tests uncovered by federal CLIA inspectors at the Theranos lab facility in Newark was used by the FDA to justify their intent to regulate LDTs. The FDA has already released a report to the public that identified instances where laboratories running LDTs were alleged to have reported inaccurate lab test results to patients and their physicians. (more…)
