The colorectal cancer (CRC) guideline-recommended screening age of 45 has intensified a screening gap—a concern in a disease that, as of 2023, has the highest cancer mortality in people younger than 50.
Dr. Jordan Karlitz, gastroenterologist and senior medical officer at Exact Sciences (now Abbott), notes: “We cannot assume that just because health care professionals know the new guidelines, everyone in the community does. Emerging CRC diagnostic tools, along with better public awareness, could help reverse rising deaths in younger adults.”
Quite simply, the gap exists because nearly 60 million individuals are not up to date with colorectal cancer screening. Noninvasive screening tests are critical because the US health system does not have enough colonoscopy capacity to screen all eligible individuals, and only 38% of eligible patients adhere to screening colonoscopy within 3 years, based on one study. In fact, it would take ~8 years to complete CRC screening at 100% participation and current colonoscopy capacity. Fortunately, multiple CRC guidelines include a variety of screening options beyond colonoscopy.
With a portfolio built on a proven stool-based test, complemented by blood-based testing and coupled with robust built-in patient outreach, Abbott is well positioned to address guideline-driven screening for CRC.
A Cologuard®-first approach to CRC screening
The Cologuard Plus® test from Abbott is a leading noninvasive CRC test that has been included in USPSTF and ACS guidelines and satisfies three years of HEDIS COL-E credit.
NCQA recently introduced a follow-up colonoscopy HEDIS measure (COF-E), placing new emphasis on what happens after a positive noninvasive screen. Because the Cologuard Plus test supports both the screening (COL- E) and follow-up (COF-E) measures, it can help health plans capture credit across the full continuum of CRC screening quality measures.
In the pivotal study, the Cologuard Plus test demonstrated 95% sensitivity for CRC (similar to colonoscopy as seen in a USPSTF review) and high specificity (91%), which translates into fewer unnecessary colonoscopies. In addition, Cologuard Plus can detect pre-cancerous polyps. For plans, that performance carries real value.
Dr. Karlitz offers insight into the value of testing methods beyond colonoscopy: “With stool-based testing, you get a cumulative sensitivity over time. For the Cologuard Plus test, if you’re getting tested every 3 years, you have multiple shots to pick up precancerous polyps and colorectal cancer at an early stage.”
A screening strategy patients can adhere to
When a test is ordered during a doctor’s visit, a Cologuard-first approach has shown high adherence rates. Based on a retrospective cohort study of ~1.5 million patients, 71% were adherent to the Cologuard Plus test within 1 year. 77% of patients adhered to follow-up colonoscopy after a positive result with the Cologuard Plus test, according to a separate study.
Cologuard can also help close the screening gap among hard-to-reach patients who may not engage with a healthcare provider, through health plan-sponsored care gap programs supported by Abbott. Care gap programs in partnership with health plans feature test kits mailed directly to eligible members. In a recent analysis of 328,775 care gap program kit orders, 34% of kit recipients completed screening within the first 6 months. Published completion rates in similar health plan-sponsored mailed FIT outreach programs have ranged from 13% to 16%. In a recent analysis of health plan-sponsored Cologuard care gap programs reported that 62% of individuals with a positive Cologuard test completed diagnostic colonoscopy within 180 days. Separately, published studies of health plan-led mailed FIT outreach programs have reported follow-up colonoscopy completion rates of less than 25% after a positive test.
Closing gaps among patients who have not completed preferred screening tests
Despite the options available, >35% of adults age 45+ were not up-to-date with CRC screening as of 2023. To help address this gap, Abbott also offers the SimpleScreen CRC™ test, an FDA-approved blood-based screening option.
The SimpleScreen CRC test can deliver incremental detection for those who remain unscreened. However, health plans and members alike should understand the limitations of blood-based testing. 79% of adults with CRC tested positive in clinical trials, while 13% with advanced precancerous lesions tested positive. As with any screening test, a positive result should be completed through a follow-up colonoscopy.
The ACS guideline lists all blood-based screening options as “nonpreferred.” Even so, tests like the SimpleScreen CRC test offer an avenue to engage patients who remain unscreened.
Using proven patient outreach programs to drive screening
Screening outreach and follow-up have been proven to reduce both CRC incidence and mortality. In these areas, Abbott brings extensive experience performing and navigating patients through more than 20 million Cologuard tests.
Dr. Karlitz offers his perspective: “Helping individuals complete a CRC screening test and making sure that they’re educated on what a positive test means and that they need a follow-up colonoscopy, is critical [to closing care gaps].”
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