Opportunity, I found this comment on trial costs. I would anticipate the lower side costs would be for a simple immunoassay using one time tests from a bank of samples.
If Moro intends to obtain FDA approval to do something like he presented at the ISOBM, then it would required extensive trials following specific breast cancer patients for a period up to a year and involve multiple testing. I seriously doubt if he would have the money for that but that's just my guess.
"Cost of Approval
The cost of clearing a device through the existing 510(k) program may range from less than $1 million to as much as $50 million, compared with $50 million to $150 million under a more- stringent FDA program for higher-risk devices such as heart pacemakers, Linda Alexander, an industry consultant at Alquest Inc. in Minneapolis, said in an interview."
News 
Market Data 
Discover 
