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wir ehrlich sind liegt das Problem doch schon in der FDA Zulassung.
Epi proColon(R) ist zugelassen für die Darmkrebsvorsorge bei Patienten mit
durchschnittlichem Erkrankungsrisiko, die nicht an empfohlenen
Darmkrebs-Früherkennungsmaßnahmen wie Darmspiegelung und stuhlbasierten
Tests ("fecal immunochemical test", FIT) teilnehmen.
https://www.ariva.de/news/...g-erhaelt-fda-zulassung-fuer-epi-5712834
Die ACS hat nichts anderes gemacht als die FDA Zulassungskriterien zu übernehmen.
Für das Routine Screening reichts nicht.
Die ACS müsste Richtlinien für die Verweigerer rausgeben oder diese mit einem Zusatz aufnehmen.
https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21457
Emerging Technologies Not Currently Recommended for Routine Screening
The following tests are not among the list of recommended CRC screening options but have been cleared by the FDA for use in special circumstances.
Methylated Sept9 DNA
The FDA recently cleared a blood test to detect circulating methylated Septin 9 DNA (mSEPT9), a molecular CRC biomarker shed by the tumor into the circulation, as a test for average‐risk individuals who have repeatedly refused other forms of CRC screening.152 According to the FDA, all tests that are available and recommended in the USPSTF CRC screening guidelines should be offered and declined before offering the mSept9 test. Because patients with a positive mSept9 test should be referred for colonoscopy, they must be prepared to undergo a follow‐up test that they previously had rejected for screening.
Most studies of mSept9 have been tandem studies comparing advanced neoplasia detection rates with a conventional CRC screening test. The USPSTF evidence report included one prospective study of mSept9 that showed a sensitivity and specificity of 48% and 91%, respectively, for detecting CRC in an average‐risk population scheduled to undergo colonoscopy.29, 153 Since the USPSTF review, a retesting of samples from the same prospective cohort using a newer version of the test yielded an improved sensitivity for cancer and advanced adenomas of 68% but a lower specificity of 80%.154 A second study using the newer version of the test involving US subjects undergoing screening colonoscopy reported similar sensitivity and specificity for screen‐detected CRC (73% and 82%, respectively).155
Although these studies demonstrate improving test sensitivity, concerns remain about poor specificity compared with recommended screening options and the limited base of evidence in asymptomatic, screening populations. In addition, there has been no microsimulation modeling of the newer version of the test to estimate its benefit, a benefit‐harm ratio, or a screening interval for regular testing, which also has not been established by the manufacturer. In addition, mSept9 is a novel blood test for CRC early detection with no comparable screening tests from which to infer a benefit in terms of critical outcomes (CRC mortality or incidence reduction), as there are for the included screening test options. Importantly, the test has not been cleared by the FDA for unrestricted use in general routine screening. Going forward, the performance of plasma DNA tests should be monitored. An accurate blood test would have obvious value in the repertoire of screening options, and even a test with somewhat poorer performance would likely make a contribution in adults persistently nonadherent to screening recommendations. In both instances, adherence would likely be high. However, based on the limitations noted above, at this time, mSept9 is not included in this guideline as an option for routine CRC screening for average‐risk adults.
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