The pre-investigational device exemption (IDE) application process is designed to provide companies that have unique diagnostic tests with informal input regarding what the FDA would look for in a formal IDE application.
This is the first step towards bringing the diagnostic test to what could prove a large market. Analysts report that the US and Europe could have a combined two million candidates to take the test each year and, for the US alone, Datamonitor projects an $80 to $160 million annual market potential.
NeuroSolutions has formed a six-person advisory committee to assist in the actual IDE filing in an effort to bring the test to market as smoothly as possible.
“The submission of our pre-IDE application is the first step in a process towards commercialization,” commented David Ellison, Applied NeuroSolutions chief financial officer. “We anticipate the next steps to include meetings with the FDA and our advisory committee to review and further refine our protocols. Following these meetings, we anticipate filing our IDE and beginning clinical trials in the first quarter of 2006.”
NeuroSolutions says its cerebrospinal fluid (CSF) test can detect Alzheimer’s disease (AD) at a very early stage with 85% to 95% accuracy.