Is the FDA registration study part of the more general Adult Respiratory Disease Diagnosis heading or the COPD screening tool?
"Adult respiratory disease diagnosis A blinded, prospective clinical study of 979 people (aged 12 years and over) in Australia showed ResAppDx-EU’s algorithms accurately diagnosed lower respiratory tract disease (LRTD), pneumonia, asthma exacerbations, and COPD exacerbations (see table below).LRTDAsthma exac2PneumoniaCOPD exac2# of Patients Yes No358 16346 73159 16386 78Positive % agreement188%89%86%83%Negative % agreement189%84%87%91%
ResApp is also developing a seperate product for COPD population screening (86% PPA, 85% NPA) for patient's without obvious symptoms or an exacerbation.
An adult FDA registration study is planned for the US winter 2020/21."
RAP Price at posting:
9.1¢ Sentiment: Hold Disclosure: Held
