Whether our BANN is predicting an outcome or diagnosing a condition might sound a mute point, but the answer has an impact on our ability to patent the invention. The EU will not allow any patents related to diagnosis.
We asked the question of the LinkedIn Global Healthcare Group.
Roberta Weiss responded as follows:
I’m a nephrologist with 10 years of industry experience and I think there’s a big difference between “prediction” and “diagnosis”, which I’ve outlined below. I’m not sure why you would be more concerned about the IP around tests or devices used for diagnosis versus predictive markers, since there’s IP around everything. Competent health care providers can diagnose many diseases and predict risks for diseases without needing to use particular methodologies, although diagnostic tests may help speed up the diagnostic process, or help improve diagnostic accuracy. Furthermore, there may be ethical concerns with the idea of “owning” a diagnosis- would this impede access to needed care? For this reason, I don’t think a manufactorer of a technology can have IP around a disease diagnosis. I’d be happy to talk to you about this more because the particulars might be helpful in understanding your question better. There are medical ethicists, for example, who might be helpful. If you’d like, plese contact me though LinkedIn.
Prediction implies probability or risk of developing a condition based on knowing risk factors, predisposing conditions, genetic markers, etc. The ability to predict is imperfect- someone can have a 75% chance of developing something but you cannot tell whether they will be in the 75% of patients who do one thing or in the 25% who do something else. However, assessment of risk can help someone change their behaviours to reduce risk factors under their control. For example, knowing that you have a certain risk of developing cardiovascular disease based on family history can help a patient make a decision to exercise, reduce saturated fat and cholesterol intake, and stop smoking, all of which may reduce their personal risk for developing cardiovascular disease. Treatments that may reduce risks of developing disease generally have relatively high benefit:risk ratios because you assume that you are treating some people who will never actually develop the disease.
Diagnosis is the recognition of a condition that already exists. Even if the diagnosis is early, there has already been some critical change or changes that have moved a patient’s physiology out of the realm of “health” into the realm of “disease”. Sometimes, predictions using different disease markers are used to stratify patients into different outcome groups, so predictions can be used even in patients who already have a disease. Often treating a disease or changing behaviours can alter possible disease outcomes, just as they would for patients with predictive risks of developing diseases. However, there are some diseases for which effective therapies do not exist. Because the disease or condition already exists, it may be acceptable to use treatments with higher risks (think chemotherapy for cancer) than for preventing disease, especially when the disease may otherwise have a devastating consequence.
“I guess, early diagnosis is based just on preliminary information. Often it can be result of your gut feelings or instincts. As a result of early diagnosis should be a summary/conclusion containing the information about the past and present events. In prediction you use these information to forecast future. Early diagnosis therefore precede prediction. On the other hand correct prediction could not be probably done without early diagnosis.