Cancer doesn’t always make itself known when it presents itself inside a person. People can live with the disease for a long time and, when symptoms manifest, it can be too late as the cancer has become advanced or has spread.
This is one of the main motivations for cancer screening programs being put in place. For conditions like breast, colorectal and cervical cancer which are increasingly common, there are sophisticated screening programmes in place designed to catch the disease. When screening annually, this can lead to much earlier diagnoses, allowing physicians to prevent cancer altogether or treat it before it becomes more serious or spreads.
However, whilst these screening programmes are in place, they’re not being utilised by anywhere near the 80% of eligible patients, which was a target set by the US National Colorectal Cancer Roundtable. Recent figures estimate that only around 65% of those people that should be getting screened are, which means 35% - over 30 million Americans – aren’t being screened for colorectal cancer.
Why? Well, this seems like a question that should be answered. To try and do that, I spoke with Jorge Garces Ph.D. He’s the CSO & President of Epigenomics, the first and only company to receive FDA approval for a blood test for colon cancer screening. Whilst technology is advancing faster than ever thanks to the continued investment in the $150 billion cancer diagnostic market, he felt that the reasons many of those screenings were being missed or avoided were altogether more human.
What’s Stopping Screening?
Over the course of our conversation, Jorge highlighted 5 main reasons that he attributed to people not getting screened for cancer. Let’s go through them, illustrating why with Jorge’s own words.
Broadly speaking, patients are more aware of cancer and its risks and on a more international or global scale “that is driving the demand for more effective diagnostic and screening methods” according to Jorge, but once the tests are approved and do exist, Jorge mentioned that patient and physician awareness does not extend to diagnostic and screening options.
“People are just not aware that these tests are available and that's been true for, for example, our test. People are not aware that there's an FDA-approved blood test for colon cancer screening.”
So if patients don’t know this technology exists, which includes those in the 35% unscreened bracket, they aren’t going to pursue being screened with it.
Ease of Access
Jorge referenced the ‘doughnut effect’ whereby it can be difficult for those living either in the inner city or in more rural areas to get tested or screened. Jorge said:
“If you think about a farmer that needs a colonoscopy. They have to one, prep, and then they have to miss a day [of work] driving. They have to get someone to drive them to the city to get a colonoscopy and then drive a very long distance to get back home. So access is important.”
For someone living outside of the city, as millions of Americans do, taking a full day out to take a test in the city just isn’t practical. And it’s also impractical for more rural doctor’s offices to invest in the latest tech for cancer screening or detection.
Going back to that doughnut effect, even for those in the inner city who can make it to the hospital in time, the latest technologies can often come at a prohibitive cost.
In the US, many of the new, innovative screening methods and tests on the market today aren’t covered by insurance which immediately rules people out. Elsewhere, in places like Europe where healthcare is often nationalised, these expensive tests won’t be included in the portfolio of a government run hospital. Meaning that expensive private healthcare could be the only route to effective screening there.
Going back to the US, one option for those who fit the criteria is Medicare, which could provide the necessary funds but as Jorge said, that system isn’t equipped for modern, preventative medicine:
“The problem with Medicare is that it's not set up to cover screening and preventative services.
When Medicare was enacted in the mid 1960’s as part of the Social Security Act it was focused on coverage for diagnostic testing and therapeutic care - to identify the disease and to treat it. So screening and preventative services are typically covered as an exception under Medicare.”
As an exception, this brings up the next reason Jorge mentioned.
Jumping through the administrative and regulatory hoops needed to get screening approved is simply too much effort for many people for something that may only say you don’t have an illness at the end anyway.
On the same token, the farmer we mentioned earlier might go to his or her regular doctor to be told that they must make a follow up appointment with a specialist many miles away to be screened. Or, be asked to send a stool sample, via post to a physician.
As Jorge put it to me, “the burden is on the patient” in either circumstance. This means that the effort involved just to get tested sees many of them slip through the net.
It’s fair to say that no one looks forward to a colonoscopy. It was even highlighted in an ad in this year’s Superbowl, starring Jason Bateman. If a patient gets told to schedule the appointment for a colonoscopy, but they feel fine – they might not, just to avoid the colonoscopy. And, the next best screening option is a stool test which is not readily accepted by the patient.
Some see that as an irrational reaction – which it is – but unfortunately, we are anything but rational creatures when faced with an unpleasant situation.
What Do We Do?
Well, one solution is a blood test like that offered by Epigenomics. Their test, Epi proColon, looks for the presence of altered DNA that originate from polyps or colorectal cancer as it stands, but they’re also working on tests for other cancers too. Let’s look at the ways in which they solve the current objections:
Awareness: Jorge mentioned the need for these types of test to be included in clinical guidelines, but once they are, the patient can simply be informed about them in their annual physical.
Access: They’re already in the doctor’s office for the physical. No specialists, or specialist equipment, needed.
Cost: Taking a blood sample is the cost of another tube of blood and the cost of a blood test for cancer detection is likely to be covered by insurance in the near future.
Effort: If you’re already having your blood taken as part of your yearly check-up, then it really is irrational not to get screened for colorectal cancer.
Experience: To many, a blood test is preferable for lots of reasons to a colonoscopy or stool-based test.
A huge obstacle is FDA approval for the technology, seen as the ‘holy grail’ for these types of tests. But even after the approval has been gained, Jorge mentioned that other obstacles lie in wait:
“Our number one focus, now that we have FDA approval is to get insurance to cover the test. Primarily Medicare because 40 percent of the market will be Medicare patients over the age of 65 and we don't want any out-of-pocket costs for elderly patients because then that will inhibit this option. These are patients that are on fixed incomes and they often don't have the cash to be able to pay for testing.”
These are significant challenges but not insurmountable. For one, they’re easier to solve because they can be handled at a governmental, or at least systematic level, instead of having to try to solve any of the other, much more individual, issues we’ve touched on.
Progressing this idea further, Jorge spoke about the potential for pan-cancer blood tests, which gets around the issue of screening for individual cancers, however easy that may become:
“A lot of times it's difficult to justify screening for a single particular cancer because the prevalence might be low in a population. But if you had a test that could identify many types of cancers then that might ... justify the cost because you're finding disease across a broader group of people.”
Epigenomics themselves are doing work looking at methylation biomarkers as opposed to genetic mutations which can be “a more general marker for cancer which provides a broader look at the presence of cancer rather than a targeted and/or temporal look based on mutation analysis”.
Ultimately, it’s advances like this from companies like Epigenomics that could hold the key to solving this problem, by making cancer screening a matter of procedure included in every routine medical, as opposed to a difficult to access, costly procedure which takes up an enormous amount of time and effort.
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