Here's some text that's been there since the update last fall but hasn't been extensively commented on. It regards the pharmacogenomics market and Ovanome in particular:
Once funding sufficient to screen 250 patients at $1,000 per patient is received, OVANOMETM will be tested in clinical trials for monitoring and reporting on the use of Taxol and Carboplatin. Our Chief Medical Officer, Hector J. Gomez, MD, PhD will lead the clinical development process.
FDA rules regarding pharmacogenomics testing are still evolving and we are seeking additional guidance from the FDA on this issue. Until OVANOMETM is FDA approved or deemed to not require FDA approval, we plan on generating revenues through physician guided Investigative New Drug studies.
The first paragraph describes testing of Ovanome as a "Medical Device" and would fall under the regulations for Investigational Medical Devices. In this regard, it would most certainly be considered a "Significant Risk Device" as it would be used to guide critical treatment decisions. This is an important distinction, in that trials of "Significant Risk Devices" require the sponsor to file an "Investigational Device Exemption" with the FDA before they may begin. IMO, that may help explain the delay we're experiencing in initiating an Ovanome clinical trial.
The second paragraph is even more intriguing. DNAPrint is NOT a pharmaceutical company (not that I am aware of at least), and the FDA DOES distinguish between IND's (Investigational New Drugs) and IMD's (Investigational Medical Devices). This text specifically refers to IND's.
What this implies is that DNAPrint plans to generate revenues in collaboration with a biotech or pharma company planning to market a NEW biologic or drug treatment. Clinical trials, or "Physician Guided Investigational New Drug Studies" are basically experiments on live subjects (usually subjects that are well along in the disease process and have few remaining alternatives). The test would probably be used to pre-classify the patient population, without necessarily using it to make treatment decisions. But, it does become an integral part of the overall data collection effort.
In addition to generating revenue from testing during the trial, the opportunity this would present is quite significant. If clear patterns of response/non-response emerge, and we demonstrate that we were able to analyze those patterns so as to predict patient response, further rounds of testing could include testing on classified responders alone. If the drug was ultimately approved we could end up in a situation where the test may be a required element in order to market the product.
I wonder if they had anyone in mind when they penned this text...
Later,
W2P
AI
