FDA meeting on BRC’s Depression Treatment Test

3 July 2012

FDA meeting on BRC’s Depression Treatment Test

BRC met with the FDA (June 28) to discuss our Pre-IDE submission in regards to the company’s test to predict optimized treatment for Depression based on our international iSPOT study.

This was a positive meeting which addressed the issues previously raised by the FDA. Significantly, the FDA considered a de novo pathway as a possible pathway for our submission. The implication of this being typically less complexity and shorter approval times as compared to a PMA submission.

As such, we continue to believe we are on track to develop and obtain FDA marketing clearance in the United States for a personalized predictive test in Depression.

Our next steps include filing a Pre-IDE supplement to clarify the pivotal validation study (expected within the next two months), this laying the ground for us to begin working on our final submission.

About iSPOT

The International Study to Predict Optimized Treatment (‘iSPOT’) is a Landmark Personalized Medicine study that is identifying objective tests to predict treatment response.

Depression is the leading cause of disability in the US and is one of its most costly illnesses (15m affected, 85m clinical visits, $83bn cost and 212 million antidepressant prescriptions in the US per annum). Current medication selection relies on a trial and error approach. The iSPOT value proposition is to identify objective tests that predict treatment response and more efficiently match which antidepressant is best for a particular individual.

iSPOT is a practical trial mirroring routine clinical practice and patients are randomized to Lexapro, Zoloft and Effexor XR (which represent around 40% of the antidepressants currently on sale in the US). It is being conducted at 20 sites globally and commenced in 2007.

About Brain Resource

Brain Resource (ASX code: BRC) translates new findings about the brain into ‘Brain products for everyday life’. With offices in San Francisco and Australia, and agents inEurope and Israel, the company is underpinned by an international consortium of scientists and clinicians that bring together all aspects about the brain that are usually assessed independently. For more information, follow Brain Resource on Twitter @MyBrainSolution or visit www.brainresource.com.