Verisante Technology Inc. V.VRS

AURA IN THE U.S IN 2013

[herbacious]

FDA approval would likely come thru PMA and would likely require additional trial data (additional to the 1,000 + lesion study) However ,until we see the full data st from the 1000+lesion study, it is difficult to determine how much additional data the FDS might require.

MELA Sciences quest for FDA approval of its skin imaging device, the FDA set 95% sensitivity (statistical at 95% conf interval ) as one of the END POINTS for the 1,400 patient clinical trial used to support their PMA application.


The interim data set from Verisante's 1,000+ lesion study showed 100% sensitivity!

Although the full analysis may indicate lower sesitivity , Verisante can ADJUST THEIR DEVICE TO INCREASE SENSITIVITY.

This would comprimise specificity somewhat although likely not nearly anywhere near as low as 9.5% specificity logged with MELA'S device in their 1,400 patient trial (an FDA advisory panel voted by a narrow margin that MELA"S device was effective despite the 9.5% sensitivity)

The Verisante management indicated that they will run a small U.S. based trial (150 patients at each of 3 sites)to supplement the data from the 1,000+lesion study.

THE COMBINED DATA , THEY BELIEVE WILL BE SUFFICIENT TO SUPPORT TO GAIN FDA APPROVAL.

do your own due diligence

herb