Can uptick in noninvasive CRC screening tests compete with standard colonoscopy?

Newly available noninvasive colorectal cancer tests have opened the doors to an uptick in screening, especially the first FDA-approved blood test. However, experts are unsure whether these will be as effective as colonoscopy.

In July, the FDA approved Guardant Health’s Shield, the first blood test approved as a primary CRC screening option. It joins the pipeline of noninvasive screening tests such as fecal immunological tests and other stool-based CRC screening tests. The agency also approved Cologuard Plus multitarget stool DNA test (Exact Sciences), the next-generation of Cologuard.

Noninvasive tests may be more attractive to patients as they are easier, more convenient and potentially less painful compared with colonoscopy. This hopefully will boost CRC screening among those who have never screened before. While health care providers believe they are a great addition to the toolbox, they fear whether tests such as Shield will be cost-effective and readily available to everyone, especially underrepresented populations.

Based on study findings, health care providers are also concerned that blood tests may not be as effective in detecting precancerous lesions and will not prevent CRC as colonoscopy would. Further, patients may not perform the tests accurately, leading to skewed results.

Healio continues to closely follow updates on CRC screening, reporting on recent research and sitting down with experts to get their insights on the addition of noninvasive CRC screening tests in an effort to decrease the rising cancer incidence. Want to see what you missed? Healio recaps the latest news in CRC including FDA approvals and research comparing noninvasive options with colonoscopy.

‘Tremendous leap forward’: FDA approves first CRC blood test

The FDA has approved Guardant Health’s Shield blood test to screen for CRC in patients aged 45 years and older at average risk for disease, according to a company press release.

With this approval, Shield is the first blood test to be approved as a primary screening option for colorectal cancer in line with other noninvasive screening options, and the first blood test to meet the performance requirements to be covered under Medicare, the company noted. Read more.

Are new CRC screening options a match for ‘the gold standard’?

New testing options for CRC will likely expand access to screening, but they are not as reliable as a colonoscopy, according to experts.

CRC is one of the leading causes of cancer death and the third most common cause of cancer in the United States, Robert Smith, PhD, senior vice president of early cancer detection science at the American Cancer Society (ACS), told Healio. The ACS has estimated that, in 2024, there will be about 46,220 new cases of rectal cancer and 106,590 new cases of colon cancer in the U.S. The organization also anticipates CRC to be responsible for about 53,010 deaths this year. Read more.

FDA approves Cologuard Plus, Exact Sciences’ next generation stool test for CRC screening

The FDA approved Exact Sciences’ Cologuard Plus multitarget stool DNA test to screen adults aged 45 years or older at average risk for CRC, according to a company press release.

Compared with the original Cologuard test approved by the FDA in 2014, the company’s next-generation test uses “novel biomarkers and improved laboratory processes,” the release stated. Further, the stool DNA test allows patients to have ample time to return their samples to laboratories boosting the rate of receiving valid results. Read more.

False-positive Shield test ‘does not appear’ to correlate with higher non-CRC cancer risk

PHILADELPHIA — Patients with a false-positive Shield test result did not appear to be at increased risk for non-CRC malignancies at 1 year compared with those with a true-negative result, according to a presenter here.

“Although there are multiple colon cancer screening options available, adherence remains suboptimal and having a blood-based screening modality represents an attractive option that could be completed at any health care encounter,” Daniel C. Chung, MD, medical co-director of the Center for Cancer Risk Assessment and director of the High-Risk GI Cancer Clinic at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said at the ACG Annual Scientific Meeting. “It has been shown that incorporating blood-based testing as a CRC screening option improves overall screening rates. Read more.

Q&A: ‘Convenience is a major selling point’ for new CRC blood test

The new blood test screening option for CRC is innovative and could improve screening uptake, but it also has some drawbacks, according to an expert.

In late July, the FDA approved the first blood test as a primary CRC screening option in line with other noninvasive alternatives. Shield, from Guardant Health, is also the first blood test to meet the performance requirements to be covered under Medicare. It is intended for patients aged 45 years and older at average risk for developing the disease. Read more.

FIT screenings linked to 33% lower mortality risk from colorectal cancer

Completing at least one fecal immunochemical test screening correlated with a 33% overall lower risk for death from colorectal adenocarcinoma, with a 42% reduction reported for cancers in the left colon and rectum, according to researchers.

“FIT screening programs have reported reduced CRC incidence and mortality, but further evidence on effectiveness is limited,” Chyke A. Doubeni, MD, MPH, chief health equity officer at The Ohio State University Wexner Medical Center, and colleagues wrote in JAMA Network Open. “Current trials of FIT have limited power, and/or are not designed to compare FIT screening with unscreened individuals.” Read more.

VIDEO: One in 10 FIT ‘unsatisfactory’ in screening for CRC, mainly due to patient error

In this Healio video, Rasmi Nair, MBBS, MPH, PhD, reports findings from a recent study, which showed 10% of at-home fecal immunological tests for CRC screening could not be processed, mostly due to specimen errors.

“We hope to learn more about where the blame lies,” Nair, assistant professor in the Peter O’Donnell Jr. School of Public Health at UT Southwestern Medical Center in Dallas, told Healio. “Is it more patient-related? Did the patient not understand the instructions with regards to FIT or was it more system- or provider-related? Although our research is great at identifying the issue, we still are not able to pinpoint the exact problem.” Read more.

Liquid biopsy not cost-effective as alternative to colonoscopy for CRC screening

The cost of liquid biopsy for second-line CRC screening was not cost-effective and would have to be reduced by 66% to increase uptake among the general population, according to data in JAMA Network Open.

“New blood tests or liquid biopsies (LBs) using circulating tumor DNA-based markers are in development for single cancer and multicancer early detection, including CRC,” Zainab Aziz, BS, of the department of medicine at Columbia University Irving Medical Center, and colleagues wrote. “These tests have better performance than previous blood-based cancer detection tests and LBs may present a more appealing CRC screening option, especially among individuals who are unscreened.” Read more.

Colonoscopy, stool-based screening outperforms blood test for CRC detection

Both colonoscopies and stool-based tests for CRC screening may be more efficient and cost-effective compared with blood-based tests, study findings published in Annals of Internal Medicine showed.

However, a combination of all the tests is likely needed to boost screening adherence, a researcher noted. Read more.