Jul 10, 2020 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Pathology, Laboratory Testing, Management & Operations
Holmes’ lawyers maintain the former CEO of Theranos has not waived right to be charged by indictment and therefore argue the added charge is ‘unconstitutional’ and should be dismissed Clinical laboratory leaders needing a break from nonstop coronavirus pandemic news will be interested to learn a familiar name is again making headlines. Disgraced Theranos founder Elizabeth Holmes—who went from paper billionaire to criminal defendant—is now facing a 12th felony fraud charge, with the additional...
Jul 8, 2020 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, News From Dark Daily
One medical testing company was led by a convicted felon, another was accused of delays and unreliable results Like many states, Florida has worked hard to quickly ramp up diagnostic testing for SARS-CoV-2, the coronavirus that causes the COVID-19 illness. For the most part this has been a good thing. However, local media in that state reported problems with two no-bid contracts for clinical laboratory testing, including one with a Dallas-based company whose founder pleaded guilty last year to...
Jun 29, 2020 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations, Precision Medicine
In the absence of a “gold standard,” researchers are finding a high frequency of false negatives among SARS-CoV-2 RT-PCR tests Serology tests designed to detect antibodies to the SARS-CoV-2 coronavirus that causes the COVID-19 illness have been dogged by well-publicized questions about accuracy. However, researchers also are raising concerns about the accuracy of molecular diagnostics which claim to detect the actual presence of the coronavirus itself. “Diagnostic tests, typically involving a...
Jun 24, 2020 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Coronavirus informatics companies are drawing clinical laboratory test data out of the shadows and into the light and compiling it into critical bioinformatics resources What better example do we have that clinical laboratory test data is critical to population health than the current COVID-19 pandemic? Medical laboratory scientists, bioinformatics developers, and government healthcare leaders are using lab test data to track the disease’s rate of infection, and through information system...
Jun 22, 2020 | Laboratory News, Laboratory Pathology, Laboratory Testing, Management & Operations
Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing While COVID-19 exploded around the world, the US Food and Drug Administration (FDA) unleashed the nation’s in vitro diagnostics developers by issuing dozens of Emergency Use Authorizations for new coronavirus laboratory-developed tests (LDTs). Most of these EUAs are for Reverse Transcription-Polymerase Chain...
Jun 17, 2020 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Washington Post investigation outlines scientists’ frustrations in the early days of the pandemic, as they worked to deploy laboratory-developed tests for the novel coronavirus In the wake of the failed rollout of the Centers for Disease Control and Prevention’s (CDC) COVID-19 diagnostic test last February, many CLIA-certified academic and public health laboratories were ready, and had the necessary resources, to develop their own coronavirus molecular diagnostic tests to help meet the...
