DNAprint Genomics (DNAG)

[worktoplay]

chig...I'm not that familiar with the European approval process. It differs from the US but is fairly stringent as well.

IMO, time is not a critical factor, even here in the US. The company can get approval to offer the tests by demonstrating clinical efficacy (the previous studies combined with the current clinical trial) and by gaining certification to offer clinical genotyping services. The FDA will allow THEM to offer the test because they developed it and have experience performing the test and interpreting the results.

This is in contrast to them manufacturing a kit, and selling the kits to third party service providers. For that model, they would need FDA approval of the test which is a more drawn out process. The primary reason is that FDA wants to assure that someone other than the test developer can perform the test and obtain accurate and meaningful results. You can't have a test in the marketplace where results vary depending on which lab is performing the test.

From what I have read of the FDA regulations governing medical test devices, the company is following the correct strategy. Gaining experience in the market by offering the "home brew" test as a service provider WILL expedite the eventual FDA approval process. At that point they will shift gears and begin marketing the tests through third parties. In the near term, the company can build a reputation in the marketplace, can demonstrate the accuracy of its tests, and add a revenue stream. Revenue will increase substantially when marketing shifts to the FDA approved test.

Contrast this to the problems Roche is having with their cytochrome P450 chips. The FDA is in an uproar not because the tests are being offered, perse, but because of the manner in which they are being marketed. They are not following an acceptable model as described in the previous paragraphs.

Don't know if this is what you had in mind, but this is my interpretation of the process the company is following. IMO it is the correct path.

Later,
W2P