Epigenomics auf dem Weg zur FDA Zulassung?!

kannst Dich wieder entspannen. Peace!


Interessante Studie von Lele Song et al
www.nature.com/articles/s41598-017-03321-8

Hierbei geht er auf die Werte nochmal ein und wie diese sich bei unterschiedlichen Studienbedingungen ändern. Je nachdem welcher Algorithmus angewendet wird sind auch bessere Werte als 71/80 erreichbar. Für Früherkennung wird der Test als sehr gut befunden. Er stellt auch neben guten Werten die Akzeptanz für den Bluttest her.

As the SEPT9 assay was shown to detect early-stage CRC with high sensitivity, it has great advantages over serum protein markers in CRC early detection. CEA is the most commonly used markers for CRC detection, however, due to its low sensitivity for early-stage CRC, it is more widely used in post-surgery monitoring of CRC recurrence and therapeutic effects, rather than a screening marker. SEPT9 gene methylation appeared to be the best blood-based single marker for CRC screening and early detection so far.

Although the SEPT9 assay did not exhibit similar sensitivity and specificity compared with FIT and FIT-DNA in asymptomatic population screening, it is a competitive option for CRC screening and early detection, as it has been shown to have higher compliance in CRC screening than FIT and colonoscopy35. A good screening test should be one that not only has high sensitivity and specificity, but also has high uptake rate by population.

The SEPT9 assay is the first blood-based test aiming at ctDNA detection for CRC screening and early detection. It shows a high sensitivity and specificity in CRC screening and early detection. The choice of algorithm is based on the needs for a test. Algorithm with high sensitivity (1/3) can be used in screening, while algorithm with high specificity (2/3 or 1/1) can be used in CRC early detection for diagnostic purpose to exclude normal subjects. The SEPT9 assay exhibited better performance than protein markers and FIT test in symptomatic population, while showed lower sensitivity and specificity than the FIT and the FIT-DNA tests in asymptomatic population. However, it provides an effective option for patients who have low compliance with FIT or colonoscopy.