Disease categories and therapies

Jan. 22, 2024
By Shani Alexander
Genotyping technology can detect COVID variants quicker
Genotype assay testing can detect new variants of the COVID-19 virus six days faster than whole genome sequencing (WGS), with results returned in just three days — compared to nine for WGS — according to a study published in the Lancet Microbe.
Jan. 2, 2024
By Simon Kerton
UW spinout Ubidx Inc. develops home test for infectious diseases
Ubidx Inc. has designed a diagnostic system comprised of a fluidic single-use disposable and a base. While the fluidic single-use disposable or cartridge is generally described as being suitable for testing a single sample, the base or hub may be used numerous times to perform numerous tests using numerous fluidic single-use disposables or cartridges.
Oct. 6, 2023
By Mark McCarty
US FDA’s updated guidance for susceptibility tests incorporates change control plans
The FDA’s draft guidance for predetermined change control plans (PCCPs) is just that, a draft guidance, but that has not stopped the agency from incorporating the underlying concepts into existing guidances. An example of this is the September 2023 guidance for antimicrobial susceptibility test (AST) system for breakpoints in device labeling, a document that represents a jarring update to the legacy version published in 2009.

Genotyping technology can detect COVID variants quicker