DNAprint Genomics (DNAG)

[mingwan0]

bag8ger, we ran the numbers on this before:

http://ragingbull.lycos.com/mboard/boards.cgi?board=DNAP&read=236196

Let's hypothesize that the FDA in it's wisdom decided to adopt biogeographical ancestry (BGA) for racial classification in US clinical trials. Given that DNAP has the patent it is safe to assume that they (or their service provider) would be the provider of relevant services. What might that mean in terms of revenue?

You have to make assumptions about number of clinical trials, average trial size (number of patients), average length of trial, cost of each BGA test, number of patients participating in trials per annum, etc. This information is not easy to come by for a number of reasons. One problem is that there seems to be no central statistical resource (I have looked at the FDA, NIH, etc). The best sources of data are sites like:

http://www.clinicaltrials.gov/

http://www.cancer.gov/clinical_trials/doc.aspx?viewid=115667A1-3A71-412C-94D6-82F4DA9234A2

From this type of source you can see that there are some 3,000 trials currently underway (excluding synonyms), of which anywhere between 1,500-1,700 relate to cancer. Some of these trials it may not be appropriate to include but let's say that are 2,000 that are relevant for our purposes.

Average trial size is difficult. I assumed this to be hundreds but one study quotes 75 studies per NDA and 4,850 patients per NDA on average (implied trial size 65). Let's be conservative and say it is 50 patients per trial.

I have seen one estimate for the average length of trials of 26 months, let's say 2 years.

Tony has given us the cost of a BGA bulk test as $160.

One source I found stated that some 25,000 people join cancer trials in the US annually. Let's say that you add on another 50% for non-cancer trials i.e. 37,500 patients.

Method 1:

2,000 trials of 50 patients each at $160 is $16 million, or $8 million per year.

Method 2:

37,500 new patients per year at $160 is $6 million per year.

Looks like a lot of revenue (using conservative assumptions) for just this one service if the FDA would be kind enough to mandate our approach.