So, the whole complimentary thing has two components to it. Here in the US (I'm not sure about our neighbors to the north), it is not approved by the FDA or any other regulatory body, for sale. Given that, I suspect that if you are giving it away, you are out of the regulatory affairs issues. It could be that while they are losing money giving it away, they are collecting data to further their move towards having enough evidence based data to do their submission for approval. Also without approval they are not allowed to advertise it or make claims for its efficacy. Given that most of what they are doing is web based, (also testing the waters talking to dentists about it at professional trade shows, but not selling anything), there probably are some loop holes for them, but the flip side of all that for consumers or dentists as customers, I guess creates a more important question. Who believes everything they read on the web? I mean after all it is an unregulated medium where every kind of pseudo-science based idea can live and thrive.... by the way I have a side business selling these little green pills that will cure baldness, ensure your male virility lasts until you are 100 (or older!) that increase your insightfulness, allowing you to grasp the gyrations of the stock market and predict its trends to become a millionaire tomorrow. They are more good things it doses. like make you irresistible to the opposite sex, but really you should buy it just on the first few benefits. Only $29.95 plus some shipping which is actually more than the product, but really are you going to notice that?
The market already has some other tests in it that make similar claims, and they got there by doing an end run around the FDA to get to market using histopathology laboratory industry standards. Those for sure do not do what they claim, but the FDA has no recourse against them. OCF has been openly vocal about them for a couple years now, but some in the dental community are willing to sell you a test based on marketing rhetoric not science.
You have to be concerned with the claims they make. Even with FDA approved products of all types, there is nobody selling anything that works 100% of the time to do anything let alone predict that you will get cancer. Not a vaccine, a drug, or a test. Human beings are unique biological entities, and given that simple fact, no two people respond to anything exactly the same way. Certainly not 100% of the time, and certainly not with predictability in most cases. If this test separates low grade dysplasia from high grade, they have told you what we all know; that there is a greater chance for it to progress to malignancy, but it does not do that with certainty, and far from 100% of the time. So what is actionable about the test? What can anyone do with certainty based on the information it provides? Nothing different that they would have done if that dysplasia had been identified through an old school small snip of tissue and looked at in a standard histopathology lab.... which still is the standard of care. You are going to opt for one of two things. Knowing that you have some cells that have taken a step towards the dark side (but may not choose to actually go there) you could have an oral surgeon laser them off. These dysplasias are superficial not invasive. That would burn it off and remove it, allowing it to heal by secondary intent. Since you had some cells do this once, the odds that it might happen again are pretty good. So the second thing you would do is be monitored more frequently by someone who knows what they are looking for and at. Because you have now been sifted out from 300 million Americans as have a predisposition for this to happen. OR you could just choose active surveillance, which many people and their doctors do, but I’m not one of them.
But this test is not a significant step forward in most research people’s minds. It does not give you additional actionable information more than conventional techniques that are currently the gold standard of the industry. Would it save a few dollars to a government that had a healthcare system, paid for by the state (actually by its citizens tax dollars), you bet and that is what this article concludes, it is not about the science of the idea and its peer reviewed validity. It is published in a journal that is more geared towards Health Economics (which is its name) not in a journal that is looking at subjects like molecular markers and such.