[europa]

So I can't remember where I saw someone post something about an issue with Precipio, but I sent the concern to the CEO and this was his response. I am actually in the process of having a sliver of my tumor sent to them for profiling. I figure, knowledge is power right?
· Yes, our TP test focuses on actionable mutations within a certain set of genes which conform to one of two options: Either (a) responsive mutations – meaning mutations in genes for which drug companies have developed therapies that are FDA approved or in clinical trials, or (b) non-responsive mutations – meaning mutations which have shown not to respond to therapies, or in fact response in a negative manner (which would lead to an action on avoiding putting the patient thru painful AND non-productive or even destructive response.
· Futhermore, our panel does use a comprehensive approach and tests for mutations that would typically not appear in certain types of cancers. The underlying philosophy that drives this approach is that the field (at least in the opinion of the Yale experts who designed these tests) is moving from a location-based cancer, to a gene-based cancer. They predict (and are in fact trying to drive the field towards this) that in the future, cancers will be classified by the gene that caused the cancer, rather than where it presented. So instead of breast cancer, patients will be diagnosed (and accordingly treated for) Her-2 cancers. Up until today, Her-2 is tested by standard for breast cancer, as you well know. But is it possible that a mutation is found in (for example) a pancreatic cancer? Literature will say no, absolutely not. But the simple reason for that is that nobody has looked for it. It’s a strange chicken-and-egg situation which we are breaking by looking for non-typical genes that are well-known in certain cancers, and looking for them in other cancers as well. That is where we look for (and often find) those unexpected results your friend was referring to.

So I agree with your friend on the fact that it is reasonable and indeed necessary to test for those genes that would be considered “typical” in one cancer – why not look for them in others. That is indeed what we do. What our TP (tumor profiling) does not do is we do not test for genes for which there are no treatments (I will caveat that because we have a test coming down the line that will – that’s for our next discussion). There are two main reasons why we test for actionable treatments only in our current TP format:

1. Focus. The reality is that most physicians like a focused and concise report that gives them information they can use to treat the patient. They do not like to receive information that doesn’t help them. Right or wrong (and I don’t think there is any one indisputable answer), I can understand that perspective.
2. Cost. This is the second factor. Of course as a cancer patient I can totally understand that money may be the last thing you care about when you are fighting for your life. My family has battled cancer and I’ve been there and know well the feeling that even if you don’t have the money, one is willing to sell the shirt on our backs to try something that may work. However, there is another side to that coin. As members in a healthcare system where costs are out of control and may very well be the one “sector” that causes an economic disaster in this country, we need to be responsible corporate citizens. This is a complicated and fine-line issue that is tough to balance, between practicality, and creating skyrocketing costs. And there is no absolute right answer. It is problematic to ignore the one factor that you as a cancer patient don’t really care about – efficiency. But this is a factor that exists whether we like it or not. In a perfect world we would do full-body CT scans and MRIs for every human twice a year. Depending on what research you read, that would most likely reduce the occurrence of cancer by an order of magnitude. But it would cost each individual about tens of thousands of dollars more in health care costs per year. Now calculate that for a family of 4, who will pay for this? You see my point and I’m sure its not a new point to you. So like it or not, cost does factor into how a diagnostics company behaves.

At Precipio, and at Yale, this is an ongoing debate and we struggle with these decisions every day. There is no right or wrong. What we have chosen currently to provide our physicians and their patients, is a comprehensive test which looks at all actionable genes and mutations, even if those are outside the standard cancer types they typically appear in. We feel that is a good balance between the “exploratory” side of genetic mutation testing, and the efficiency side.

Now to the competition, I will try to point out the differences with a couple of the competitors, I will refrain from mentioning names because that can get us into legal trouble, but you’re smart enough to put 2 + 2 together:
1. Competitor A
· Some companies use a combination of technologies (rather than one single technology) that are either unproven scientifically, or outdated. There is a problem with results consistency when multiple technologies are combined, and especially when they are not substantiated by clinical evidence. Every single mutation conducted at Yale has been clinically validated – if you would like I can send you a 160-page document that includes all that data – excellent bedtime reading, guaranteed to put you to sleep in moments…J. We used sequencing which is the cutting edge technology that undoubtedly will be the driver of this field. Micro-array is questioned in many forums as a valid technology, and IHC is simply old-school technology, outdated and lower accuracy than sequencing.
· Specimen size needed – this may or may not be relevant to specific patient situation, but overall this is becoming a major issue as biopsies are becoming smaller and smaller (which is great for the patient – less invasive procedures). The problem is by the time the standard tests are done, there is often very little tissue left for our types of tests. If you look at some of the competitor’s requisitions, they asks for 50+ slides, which is a huge amount of tissue. This again is because different technologies are used and so they require multiple slides for each machine they use. Our test requires 5 slides and we’ve been known to do it with only 1-2 slides.

2. Competitor B
· There are new players that are very interesting, and are really ahead of the game, and I commend them for that. I have no doubt that perhaps in 3-5 years, the tests they are doing may become standard. By then there will be more evidence and more applicability to those genes tested (in terms of targeted treatment outcome); also costs will hopefully come down, making it more affordable. But for now I have heard numerous physicians remark the following about these kinds of tests:
i. As mentioned before, the report goes beyond actionable genes, and so physicians I’ve spoken with get frustrated with getting a long report that they have a hard time figuring out how to actually treat the patient (which is what they are ultimately looking for, and is a good thing, right?). they view sometimes less as being more, I guess is one way of putting it.
ii. Cost. These tests are billed at over $5,000 and some insurers are refusing to pay for it. From the insurance company’s perspective they are saying something like: “If out of the 150+ genes tested, only ~10 have information that can help the physician treat the patient, why are we paying for the other 140?” I’m not saying there isn’t a good answer to that question, but that’s their position as a profit-driven insurance company. Physicians also (rightfully so) see themselves as corporate citizens of the healthcare system, and so they see a problem with ordering such tests for that reason as well.

From a cost perspective our test runs between $800-$2,400, and has been approved by medicare and private payers. Yale has never had a claim rejected, and I think that goes to show we’ve found a good balance between good science, efficiency and cost.

Sorry for the long winded answer, hope this helps you and your friends. Happy to discuss this further, whether by email or phone.