recombinase polymerase amplification
The assay detects HPV 16 and HPV 18 DNA within 45 minutes and is intended to be used in low-resource settings.
Midge Medical Receives CE Mark for Handheld Isothermal MDx, COVID Test
The firm obtained the CE-IVD ahead of the implementation of the In Vitro Diagnostic Regulation, and it expects to launch the system in Germany in the fourth quarter.
The portable device runs an isothermal amplification assay to detect genetic material from strains of tuberculosis in resource limited areas.
The system uses off-the-shelf laboratory components and currently runs an Ebola assay based on isothermal amplification chemistry from Alere subsidiary TwistDx.
PATH Team Completes Prototype Electricity-free Reusable MDx Platform; Eyes Disposable Version
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The platform — called NINA for non-instrumented nucleic acid amplification — is designed to work with a wide range of isothermal amplification methods.