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Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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BioWorld MedTech’s Diagnostics Extra for Sept. 10, 2020

Sep. 10, 2020
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics, including: Deep learning aid for diagnosing TB in HIV patients; Self-collected swabs vs. health care worker collected for COVID-19 testing; SCAD vs. plaques in heart attacks; Diagnosing neuroblastoma in children.
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Ultra-sensitive antigen testing could help identify patients at risk for severe COVID-19

Sep. 10, 2020
Digital illustration of U.S., coronavirus

Ultra-sensitive antigen testing could help identify patients at risk for severe COVID-19

Sep. 9, 2020
By Mary Ellen Schneider
A new type of SARS-CoV-2 antigen test that relies on single molecule array technology may be able to help clinicians identify which patients are most likely to experience severe disease.
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Liver organoid
Multiple drugs, single model

Organoids enable due DILIgence on liver toxicity

Sep. 9, 2020
By Anette Breindl
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), drug-induced liver injury (DILI) is the leading cause of acute liver failure in the U.S. It is also a leading cause of drug failure in clinical trials. Now, researchers have used liver organoids to develop a polygenic risk score that could predict the risk of liver toxicity for multiple different drugs, regardless of the underlying mechanism.
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FDA approves Detectnet

Sep. 9, 2020
Women scientists in lab

Novacyt launches respiratory virus test panel that differentiates COVID-19 from common winter diseases

Sep. 8, 2020
By Bernard Banga
PARIS – Novacyt SA has obtained CE marking approval for its polymerase chain reaction (PCR) respiratory virus test panel, Winterplex.
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FluoGuide obtains Danish clearance for phase I/II trial of FG-001 to guide glioma surgery

Sep. 7, 2020
Mobiledetect Bio BCC19 test kit

Detectachem wins EUA for rapid COVID-19 test kit

Sep. 3, 2020
By Mary Ellen Schneider
Detectachem Inc. has scored an emergency use authorization (EUA) from the U.S. FDA to market a new molecular RNA test kit for SARS-CoV-2 that provides color-coded results in about 30 minutes.
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BioWorld MedTech’s Diagnostics Extra for Sept. 3, 2020

Sep. 3, 2020
By Meg Bryant
Keeping you up to date on recent developments in diagnostics, including: A simple point-of-care COVID-19 test; A deep-learning method to predict AMD risk; AP-1 and antidepressant action; Orasure collection device included in Miradx EUA.
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FDA icons

FDA eyes self-administered testing for COVID-19 antigen tests

Sep. 2, 2020
By Mark McCarty
The need for self-administered surveillance testing finally has a few candidates, thanks to labs and test developers across the globe, and the U.S. FDA is keen on exploiting the opening. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the agency’s Sept. 2 testing town hall that the agency is interested in a test intended to be self-administered multiple times compared to a test validated under a single test approach, a flexibility that may prove critical in advancing the U.S. approach to testing for the COVID-19 pandemic.
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