Apr 28, 2021 | Clinical Laboratory/Pathology Automation, Analyzers, Testing Systems, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, News From Dark Daily
Federal regulators continue to recognize value of clinical laboratory testing in near-patient settings To help in the diagnosis and management of two sexually-transmitted diseases, another point-of-care diagnostic test will soon be available for use in physician’s offices, urgent care clinics, and other healthcare settings. The federal Food and Drug Administration (FDA) announced it granted a CLIA waiver for the binx health io CT/NG assay, a molecular platform used to detect sexually...
Apr 23, 2021 | Clinical Laboratory/Pathology Automation, Analyzers, Testing Systems, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, News From Dark Daily
Dozens of Chicago-area schools were reopened with the help of an $11 COVID-19 saliva test, but the qualifications of the clinical laboratory, and whether it complied with federal regulations, were called into question It was only a matter of time when newly-formed clinical laboratories—taking advantage of the federal government’s loosening of regulations to promote COVID-19 testing—drew the attention of state regulators and the national news media. This is what happened at New Trier High...
Sep 3, 2014 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs After sitting in a state of suspended animation for several years, the Food & Drug Administration’s (FDA) plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of LDTs. If the federal agency wanted to get the...
Feb 4, 2013 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Telemedicine allows U.S. pathologists and other specialists to boost revenue by consulting with international partners. Pathology laboratories in the United States are among the first adopters of a trend toward international telemedicine. Pathologists working at a handful of well-known healthcare organizations here in the United States are forming partnerships with other hospitals and health systems worldwide, particularly in China. Pathology Is Just One Medical Specialty Doing Global...
Aug 6, 2012 | Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
23andMe executives want the credibility that FDA clearance provides for its DNA tests and declared their intent to eventually support more clinical laboratory test applications Offering genetic tests directly to consumers is a controversial subject among some pathologists and healthcare ethics experts, who question both the science of these tests and whether consumers will do the right thing with the information. Now that debate is likely to heat up, because direct-to-consumer genetic testing...
