Ann: Further Positive Results From Adult Clinical Study-RAP.AX, page-3

ResApp Announces Further Positive Results from
Adult Clinical Study
- Achieved high levels of accuracy (91%-100%) for distinguishing adult patients
with URTI, COPD, asthma or pneumonia from subjects with no discernible
respiratory disease
- Demonstrated differential diagnosis of asthma versus COPD, pneumonia
versus asthma and pneumonia versus COPD at 88%-94% accuracy
- Correctly detected lower respiratory tract disease in 84% of adult patients
initially diagnosed as clear by experienced clinicians using stethoscopes
- Finalised clinical protocol and confirmed three leading US hospitals for US
paediatric study, SMARTCOUGH-C
Perth, Western Australia, 3 October 2016 -- ResApp Health Limited (ASX: RAP) today
announced further positive results from its adult clinical study underway at Joondalup
Health Campus (JHC) and the Wesley Hospital. This additional set of preliminary
results, prepared by the team led by Associate Professor Udantha Abeyratne at The
University of Queensland, again demonstrates high levels of sensitivity, specificity and
accuracy on an expanded adult dataset.
ResApp’s cough sound-based algorithms achieved between 91% and 100% accuracy
for distinguishing adult patients with chronic obstructive pulmonary disease (COPD),
asthma or pneumonia from subjects with no discernible respiratory disease. In
addition, the new analysis demonstrated accuracy of 100% for distinguishing patients
with an upper respiratory tract infection (URTI) from the no respiratory disease group
(not previously reported). The differential diagnosis of asthma versus COPD,
pneumonia versus asthma and pneumonia versus COPD (not previously reported) was
achieved at an accuracy in the range of 88% and 94%. The complete set of results,
including sensitivity and specificity are given in the table below.
As was found in the paediatric study, the algorithms were able to correctly detect lower
respiratory tract disease in 84% of adult patients who were initially diagnosed as clear
by experienced clinicians using stethoscopes but were finally diagnosed as having a
lower respiratory tract disease after additional clinical testing.
“We are pleased to again report high levels of accuracy in a significantly larger dataset,
which continues to build our clinical evidence base as we progress towards FDA
submission,” said Tony Keating, CEO and Managing Director of ResApp. “It is also
excellent to note that once again our algorithms outperformed experienced clinicians
by correctly detecting lower respiratory tract infection in patients initially diagnosed
as clear.”
As with previous analyses, the performance of the algorithm was evaluated using the
method of leave-one-out cross-validation against the final clinical diagnosis. ResApp
notes that these results are preliminary and may change as the clinical study
progresses. Recruitment of adult patients continues at JHC and the Wesley Hospital.
ResApp’s US paediatric clinical study is also progressing well. SMARTCOUGH-C is a
prospective, multi-site, double-blind study that will evaluate the efficacy of the
ResAppDx software application in the diagnosis of childhood pneumonia and other
respiratory conditions from cough sounds. Three leading US hospitals are now
confirmed as study sites, with enrolment to take place at multiple locations within each
hospital. The SMARTCOUGH-C clinical study protocol has been finalised and the study
will begin following approval by each site’s institutional review board, which is
expected within two to six weeks.

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