SANTA CLARA, Calif., Nov. 9, 2010 /PRNewswire-FirstCall/ —
NewCardio, Inc. (OTC Bulletin Board:
NWCI), a cardiovascular diagnostic solutions developer,
announced today that Dr. Samuel George, NewCardio’s Senior Medical
Advisor, will present the results of QTinno performance on a
blinded “testing” dataset, conducted independently by the Cardiac
Safety Research Consortium (CSRC), at the CSRC’s Annual Meeting, to
be held on December 9, 2010, at the headquarters of the Food and
Drug Administration (FDA) in Silver Spring, MD.
At the meeting, Dr. George will present results of a blinded
validation study in which CSRC-affiliated investigators
independently evaluated the accuracy and precision of fully
automated QTinno measurements in 11,672 electrocardiograms (ECGs)
from the moxifloxacin and placebo arms of a recent Thorough QT
Study (TQTS). In the study, the CSRC investigators made detailed
comparisons of QTinno measurements to those originally submitted by
the drug sponsor, with the primary comparators of accurate
detection of the moxifloxacin effect on QT intervals.
The CSRC makes this blinded TQTS “testing” dataset available to
automated cardiac safety technology solution providers, with the
conditions that the blinded analysis is conducted independently by
the CSRC without any company involvement, and that any (either
favorable or unfavorable) results obtained will be made public.
NewCardio is the first company which has agreed to these conditions
and completed the evaluation.
Dr. Ihor Gussak, NewCardio’s Chief Medical Officer, commented,
“We are very proud to be the first automated cardiac safety
solution to accept the rules of engagement defined by the CSRC for
evaluating the performance of our automated solution, QTinno,
utilizing the blinded CSRC ‘testing’ dataset. Our willingness to
enter into this very important and strictly regulated