On July 29, the FDA approved a new screening test for colorectal cancer that requires only a blood sample, providing a less invasive option for patients who are hesitant about traditional screening methods.
While the Shield blood test, created by Palo Alto, Calif.-based Guardant Health, led to physicians detecting 83% of colorectal cancers in studies, it is considerably less effective when it comes to the detection of precancerous polyps.
While colonoscopies find approximately 95% of these polyps, Shield found only about 13%. In addition, false positive and false negative rates remain high for blood and fecal-based colorectal cancer tests.
Though the FDA's approval of the Shield test is considered a promising step in widespread adoption of blood-based screening, other factors, including payer approvals, could still stand in the way.
Despite gastroenterologists nationwide lauding the Shield test, if payers will not cover testing, paying out of pocket for screenings may be cost prohibitive for some patients.
William Sellers, MD, chief of robotic colorectal surgery at St. Charles Hospital in Port Jefferson, N.Y., and St. Catherine of Siena Hospital in Smithtown, N.Y., spoke with Becker's about the potential impact of this new screening tool and the future of new technologies in the gastroenterology and colorectal cancer space.
Question: Can you talk about the FDA's recent approval of a CRC screening blood test? What pros will this bring to GI care?
Dr. William Sellers: This is pretty exciting because, as a lot of the articles have mentioned, about one-third of people are currently not being screened at all due to lack of knowledge or embarrassment or invasiveness of the procedure. Because of that, colon cancer, which is technically 100% preventable if you do early screening, is now the second-most-common cause of cancer death in the country. The rate seems to be rising, especially in younger individuals. Because of that, we've lowered the screening age from 50 to 45, but I have patients in their 30s and early 40s being diagnosed. Anything that will increase access to screening and will encourage patients to get in and get screened is a good thing. I think this is some exciting technology, where you can do this without any invasiveness. No prep, no colonoscopy, no anesthesia, just a simple blood test. This is probably the start of something that will only continue to grow and the technology will only get better.
Q: What are you hesitant about, if anything, with new blood and stool tests on the market?
WS: The big thing is both Cologuard stool tests and blood tests have pretty significant false positive and false negative rates. You assume a colonoscopy has a pretty lower rate of that. There's two sides to that. One, if you test negative, there's a 13% chance you do have cancer. If it was me, I would be worried about that, so I would always get a colonoscopy. The other side of that is if you are using this in patients who won't get a colonoscopy anyway, then this is a tremendous advantage. You miss 100% of cases in people you don't screen.
The other side, from the GI provider perspective, is that false positive rates create a certain amount of anxiety. You can imagine how nerve-racking that is as a provider when you're expecting to find something and there's nothing there. False positives worry patients as well. Particularly for this test, concern overall is that it doesn't detect polyps accurately at all. The real benefit of a colonoscopy is that you can not only detect, but prevent cancer by removing precancerous spots. If you're just doing a spot like this, you're just waiting for cancer to develop.
Q: How do you think payers and prior authorization rules will impact the widespread adoption of new CRC screening options?
WS: That's the $54 million question. Everything that comes out always comes down to what will the insurance companies cover. The one good thing I read about this is it does seem with FDA approval, Medicare will reimburse and cover this. Usually in most situations private insurance follows Medicare's example, though that's not always 100% the case. Every time we as physicians come up with new tech or treatment or a new plan that's going to benefit patients, it will not be effective if the insurance companies aren't going to reimburse, aren't going to pay for it, so I think that will be the ultimate determining factor for how useful this treatment will be. Hopefully now that the FDA has approved it and Medicare will reimburse for it, that will cover a lot of people in the screening age group. If they were to lower the recommended screening age, people who could benefit from this may have to pay out of pocket. I even have patients whose insurance companies try to refuse to cover colonoscopies because they aren't a 'right fit.' Some have not adopted to the age of 45 screenings, even though that has been a recommendation for years now. What insurance will cover is the biggest hurdle facing every patient and physician in America.
Q: What other industry trends are you keeping an eye on right now?
WS: The big thing continues to be the growth in minimally invasive surgery to deliver better outcomes and widen patient access. There's newer and better robots coming out in the market. We primarily use Intuitive Surgical's robots, but there are other robots coming out and that technology continues to expand. Even Intuitive released two new robots last year. That is the most substantial thing that is actively changing. For the last 20 years, there was essentially one company in the space, and now you have several entering the space so that seems to be a tremendous advantage because competition will drive newer and better tech all the time, which will translate to better outcomes for patients.
Q: How will this new screening option improve access for patients?
WS: These tests are great and the more of them the better. It's exciting that we're pushing the envelope on how minimally invasive screening tools and surgeries can be. It all just benefits the patients, getting them healed faster with shorter hospital stays. It's exciting that we as a country continue to push for that, and the only other issue of concern is access. This test does improve access; nationwide there is lack of access for care in certain specialties. In New York, there's a lack of gastroenterologists and a lot of times GI specialists are booked out several months in advance. This can lead to poor access to care as far as necessary screening tools, so less invasive tests help in that regard and get more people screened. If we improve access, that will result in better outcomes, which is the goal for all of us.