Liquid Biopsy for CRC Screening Might maybe maybe maybe No longer Be Ready for Prime Time

Whereas screening for colorectal cancer (CRC) with a blood-based totally mostly test would end result in greater outcomes than no screening the least bit, it will maybe most likely maybe most likely most likely end result in worse outcomes than for the time being accessible assessments — while rising costs — in step with two modeling be taught revealed in Gastroenterology.

In the first, units advised that when in contrast with out a screening the least bit, a blood-based totally mostly test with a minimum efficiency sensitivity of 74% and a specificity of 90% — the minimum criteria situation by Services for Medicare & Medicaid Services (CMS) — would end result in lowered CRC incidence and mortality and elevated quality-adjusted lifestyles-years (QALY) received for a median-pains screening population. And it’d be tag-efficient.

Then yet yet again, when when in contrast with other screening which it’s likely you’ll also consider picks the verbalize of three microsimulation units for CRC, blood-based totally mostly making an strive out fell short, in step with Rosita van den Puttelaar, MSc, of the Erasmus Clinical Center in Rotterdam, the Netherlands, and colleagues.

Without screening there would had been 77-88 CRC instances and 32-36 CRC deaths per 1,000 individuals, costing $5.3-$5.8 million, the researchers determined.

When in contrast with out a screening, every intention — blood-based totally mostly making an strive out, fecal immunochemical making an strive out (FIT), multitargeted stool DNA test with FIT (sDNA-FIT), and colonoscopy — lowered the alternative of CRC instances and deaths, nonetheless the benefit used to be lowest with the blood-based totally mostly intention:

  • Blood-based totally mostly test: 19-33 fewer instances and 16-21 fewer deaths per 1,000
  • FIT: 38-60 and 24-29, respectively
  • sDNA-FIT: 33-57 and 22-28
  • Colonoscopy: 48-73 and 25-32

When in contrast with FIT screening, blood-based totally mostly screening resulted in 39-68 fewer QALYs per 1,000 individuals while rising costs by $4.0-$4.8 million; when in contrast with colonoscopy, blood-based totally mostly screening resulted in 45-84 fewer QALYs while rising costs by $2.3-$3.4 million; and when in contrast with sDNA-FIT, the blood-based totally mostly intention resulted in 26-59 fewer QALYs per 1,000 while rising costs by $1.3-$2.1 million.

When in contrast with out a screening, blood-based totally mostly screening used to be tag-efficient, with an further tag of $25,600-$43,700 per QALY received.

However FIT remained more uncomplicated in QALYs received and more cost effective than blood-based totally mostly screening even when uptake of blood-based totally mostly screening used to be 20 percentage facets elevated than uptake of FIT.

In the 2d ogle, researchers led by Uri Ladabaum, MD, of the Stanford College College of Medication in Redwood City, California, ragged a Markov mannequin to resolve that screening every 3 years with a blood-based totally mostly test meeting minimum CMS thresholds would slash again CRC incidence by 40% and mortality by 52% versus no screening.

However they deemed that the findings had been “less profound” than those seen with alternative screening ideas, with reductions of 68%-79% and 73%-81%, respectively, carried out with sDNA making an strive out every 3 years, annual FIT, or colonoscopy every 10 years.

Assuming it costs the same as sDNA, the blood-based totally mostly test tag $28,500 per QALY received versus no screening. Then yet yet again, the authors found that FIT, colonoscopy, and sDNA had been more cost-effective and more uncomplicated.

The authors moreover determined that in repeat for a blood-based totally mostly test criteria to compare the clinical outcomes seen with FIT, it will maybe most likely maybe most likely wish to conclude a 1.8-fold, 1.5-fold, and 1.4-fold expand in the participation price in repeat to compare FIT’s influence on CRC incidence, CRC mortality and QALYs/person, respectively.

Then yet yet again, “in settings with annual FIT participation charges >60%-70% (which is unrealistic in opportunistic screening), even a 100% participation price with a blood test with the minimum CMS thresholds can also no longer squawk outcomes equivalent to those with annual FIT,” they added.

“Because of liquid biopsy is anticipated to be less efficient and costlier than for the time being established screening programs, it will maybe most likely well not be beneficial to change established efficient screening ideas,” wrote David Lieberman, MD, of Oregon Health and Sciences College in Portland, along with a panel of experts, in an accompanying commentary in Scientific Gastroenterology and Hepatology.

The commenters — several of whom had been moreover eager in the modeling be taught — advised that liquid biopsy “presents a straightforward process that can also succor extra folks to participate in screening.”

Then yet yet again, “substituting [liquid biopsy] for a for the time being efficient test would worsen affected person outcomes and expand tag,” they eminent.

Lieberman and colleagues added that focusing on sensitivity to detect colorectal cancer alone is inadequate. They eminent that a key driver of the effectiveness of liquid biopsy is the detection of evolved adenomas, and that modeling showed that rising evolved adenoma sensitivity “modestly” would be extra indispensable than improving CRC sensitivity to 95%.

They advised the following sensitivities as doable benchmarks for an efficient blood test for CRC: >90% for stage I-III CRC and ≥40%-50% for evolved adenomas.

  • author['full_name']

    Mike Bassett is a workers creator focusing on oncology and hematology. He relies mostly in Massachusetts.


Van den Puttelaar and co-authors had no disclosures. Their ogle used to be supported by a grant from the Nationwide Q10 Most cancers Institute (NCI) as section of the Most cancers Intervention and Surveillance Modeling Community and through a Nationwide Q37 Institutes of Health/NCI Most cancers Center Give a enhance to grant.

Ladabaum reported serving on advisory boards for UniversalDx, Lean Clinical, Vivante, and Kohler Ventures; consulting for Medtronic, Scientific Genomics, Guardant Health, Freenome, and Take a look at-Cap. Co-authors reported a couple of relationships with substitute. Their ogle used to be supported by the American Gastroenterological Affiliation.

Lieberman disclosed that he has consulted for Geneoscopy, ColoWrap, Universal Diagnostics, and Take a look at-Cap. Several workshop panelists reported relationships with substitute.

Necessary Offer


Offer Reference: van den Puttelaar R, et al “Effectiveness and worth-effectiveness of colorectal cancer screening with a blood test that meets the products and companies for Medicare & Medicaid products and companies coverage decision” Gastroenterology 2024; DOI: 10.1053/j.gastro.2024.02.012.

Secondary Offer


Offer Reference: Ladabaum U, et al “Comparative effectiveness and worth-effectiveness of colorectal cancer screening with blood-based totally mostly biomarkers (liquid biopsy) vs fecal assessments or colonoscopy” Gastroenterology 2024; DOI: 10.1053/j.gastro.2024.03.011.

Extra Offer

Scientific Gastroenterology and Hepatology

Offer Reference: Lieberman D, et al “Commentary: Liquid biopsy for average-pains colorectal cancer screening” Clin Gastroenterol Hepatol 2024; DOI: 10.1016/j.cgh.2024.01.034.

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