Apr 15, 2020 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Following criticism over delays in authorizing medical LDT COVID-19 tests, the FDA swiftly shut down consumer at-home specimen collection schemes Banning COVID-19 tests that rely on consumers’ collecting their own specimens at home is one example where the federal US Food and Drug Administration (FDA) took remarkably swift action. It’s also interesting to note how some business people—who lack formal training in clinical laboratory medicine—often are ready to seize any opportunity to sell lab...
Sep 21, 2015 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Pathology, Laboratory Testing
This secretive start-up medical laboratory testing company has not disclosed how its diagnostic test technology works, nor has it given laboratorians an opportunity to examine the technology Several internationally-respected clinical laboratory experts are asking serious questions about Theranos and its diagnostic testing technology, and they’ve gotten few answers to date. Though the number of experts is small, their credentials in the clinical laboratory profession are impressive. In...
Aug 17, 2015 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
By placing this low-cost, disposable device developed at the University of Wisconsin-Madison on their arms or abdomens, patients can collect their own blood at home in minutes For more than two years, the nation’s media have been captivated by Theranos CEO Elizabeth Holmes’ vision of offering patients who need blood tests a finger stick collection instead of a venipuncture. Meanwhile, in research labs across the nation, there are credible efforts to develop ways to collect medical laboratory...
Jun 19, 2015 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Flow Health Hub device could be disruptive to medical laboratories, as it will be designed to allow patients to perform their own diagnostic tests to monitor pre-existing conditions Another biotech company has its eye on medical laboratory testing and wants to bring to market what it describes as a consumer do-it-yourself test device. The company is designing the device to let consumers do fitness monitoring. But it hopes the device will also allow consumers to monitor pre-existing conditions...
Nov 12, 2014 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Prenatal genome sequencing raises ethical issues for gene sequencing labs and clinical labs, since a baby’s genetic information may present lifelong consequences for that individual Pathologists and clinical laboratory managers will be interested to learn that another milestone in genetic testing was reached earlier this year. A geneticist at the University of California at Davis, has sequenced the whole human genome of his unborn baby, the first time this feat has been accomplished. Notably,...
