LabCorp hat u.a. auch die Praktikabilität unseres ProCOlon Tests überprüft mit gutem Ergebnis:
Discussion
The Epi proColon® test, as the rst FDA-approved blood test for colorectal cancer screening, o ers a non-invasive method more likely to be accepted in the popula on who con nues to resist screening. To date, access to healthcare and conveniences associated with ge ng tested have been major barriers that have prevented screening. From a pa ent perspec ve, personal factors that cause pa ents to be unwilling or unable to accept the more tradi onal endoscopic and stool methods may be overcome by this common method of blood tes ng. From an access point of view, o ering this blood test through a large na onal clinical laboratory with widely-dispersed community collec on centers provides a tes ng convenience that serves to enhance screening opportuni es.
Overall, the Epi proColon® test valida on demonstrated results for accuracy and precision comparable to the assays established performance characteris cs reported in the IFU.
Außerdem wurde nochmals bestätigt, dass die von Epigenomcis gemachten Angaben zur Akkuratheit des Tests in der Praxis bestätigt wurden.
Conclusion
The Epi proColon® test is a simple and robust, Real-Time PCR assay for molecular CRC screening of asymptoma c pa ents using cell-free plasma specimens. Following established protocols for new test assessments, the Epi proColon® valida on results were comparable to the manufacturers stated performance characteris cs. Familiar PCR methodology with minimal operator to operator variability enables easy test integra on into clinical molecular laboratory work ows. To accommodate standardized na onwide process logis cs for test use in collec on centers, standard 4 mL EDTA Vacutainer collec on tubes were validated. Since on-boarding the Epi proColon® test, there has been a steady increase in u liza on by the domes c clinical-referral base. As a large clinical laboratory with extensive na onal outreach capability, this test extends the ability to provide greater access to non-invasive CRC screening with a blood test op on to providers and their pa ents. By mid-2017, 2,238 Epi proColon® tests were received and processed from the clinical referral base for individuals of recommended screening ages 50-74. For those people who remain resistant to other methods for CRC screening, the availability of a blood test that may be conveniently drawn at a local community collec on center may help surmount barriers of non-par cipa on.
Letzter Satz auch noch mal wichtig: Die Fälle, die kein Ergebnis zuliessen i.H.v. 2,5% sind vergleichbar mit FIT Still DNA besser bekannt als Cologuard.
The LabCorp clinical laboratory processed 2,238 Epi proColon® tests submi ed by clinical providers from pa ents of screening- age by mid-2017. Of these specimens from pa ents ages 50-74, 75.1% and 22.4% obtained nega ve and posi ve Epi proColon® test results, respec vely. Due to limita ons surrounding con den ality, outcomes for pa ents obtaining posi ve results were unknown. Results could not be obtained in 2.5% of specimens due to insu cient recovery of plasma DNA. We found this rate comparable to exclusions found for other molecular methods such as FIT-stool DNA (2.2-3.8%) [30,31].
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