wie im Jama Artikel zur USPSTF Empfehlung (siehe #3551) angegeben.
Zukünftig meines Erachtens besonders wichtig die mit der Zulassung angeordnete Nachfolgestudie (Seite 41):
"... CDRH issued an approval order on April 12, 2016. The final conditions of approval cited in
the approval order include performing a post-approval study (PAS). The Epi proColon PAS
will be a single arm, prospective, longitudinal, multi-center study to evaluate the performance of
the device upon repeat use (i.e., second screening one year later, T1) in patients of average risk
for CRC who, after appropriate counseling from their healthcare provider, have been offered
and declined screening by USPSTF recommended methods. It is expected that 4,500 study
participants will be enrolled. The primary endpoints are: (1) the proportion of participants at T1
with a positive test result, but without colorectal cancer, is significantly less than the proportion
of subjects at the first screening (T0) with a positive test result, but without colorectal cancer;
and (2) the test detects CRC at T1 in patients tested negative at T0. The secondary endpoints
are: (1) the cumulative probability of cancer detection; (2) the cumulative probability of a false
referral; (3) the probability of testing negative at both time points; (4) the adherence to Epi
proColon at both screenings (i.e., T0, T1); (5) the diagnostic yield; (6) the adherence to followup
diagnostic colonoscopy after a positive Epi proColon test; and (7) the assay failure rate.
..."
Das Folgekriterium (1) "2xFehlalarm" (T1 positiv << T0 positiv) und (2) "CRC-T1-neu" ist meines Erachtens auch nicht ganz leicht zu erreichen und schützt die alten Verfahren vermutlich weiterhin.
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