FDA Grants CLIA Waiver Allowing First Test for Chlamydia and Gonorrhea to Be Performed at the Point of Care

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...

Smartphone “Dongle” Achieves Capabilities of Big Clinical Laboratory Analyzers: Diagnoses Three Diseases at Once from Single Drop of Blood

Oct 5, 2015 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology

This breakthrough in technology miniaturization holds great promise for improving public health, but portends a disruptive future ahead for the medical labs  Is the medical laboratory industry ready for a handheld device that can do immunoassay testing without requiring any stored energy? The secret of this device, already undergoing field trials in Rwanda, is that it uses a smartphone accessory, or “dongle,” to capture and transmit the results of the lab tests. This innovative smartphone...

Pathologists Could Have DNA Sequencing Device That Connects to a Smartphone and Can Produce Immediate Results from Several Types of Medical Laboratory Samples

Jul 16, 2014 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology

At the proposed $1,000 price tag, Biomeme’ mobile clinical laboratory device has the potential to challenge diagnostic systems used in central laboratories Another smartphone gadget capable of performing diagnostic laboratory tests is headed for the marketplace, and only time will tell if it proves to be a threat to the in vitro diagnostics industry. Developers say that, when paired with a smartphone, this diagnostic device is similar to traditional medical laboratory technology 10 times its...

British Researchers Working on a Way to Use Cell Phones to Perform Pathology Tests for STDs

Nov 22, 2010 | Laboratory News, Laboratory Pathology

Clinical laboratory-on-a-chip would cost under £1 and allow young people to test themselves for sexually-transmitted diseases Some wags call a new diagnostic testing concept the “pee in the cell phone” pathology lab test. The humor is directed at cell phone-based medical laboratory tests under development in the hopes that this confidential and private diagnostic test method will encourage more young people to undergo testing for sexually-transmitted diseases (STDs). Newspapers in the United...
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