Edison Investment Research

Epigenomics AG

Company overview

Initial data from the PRESEPT study on the bowel cancer test, Sept9, were released on 15 January. One laboratory had a lower detection rate than the others but it seems likely that Sept9 will detect 50-62.5% of colon cancer patients including many patients with curable early stage disease. An audit of the laboratories is ongoing and retesting of samples may occur. Final data should be released by late March. However, 96.5% of positive tests will prove negative on colonoscopy examination.

Date	Reports available	Download
Mar 10 2010	Positiver Ausblick PRESEPT study issues have been resolved by sample retesting. The reasons for the outlier results have not been disclosed. The academic steering group has shown that test sensitivity (percentage of true cases) is 62.75%. The specificity is low at 89% (percentage of true negatives). Helpfully, the negative predictive value (NPV) was calculated at 99.7%; this is the probability that a negative test results is really negative. Sadly, the positive predictive value (PPV), the chance that a positive SEPT9 result is true, was not estimated. To be helpful, we calculate this at 3.56%. Research type: QuickView	Log in to download 2 page note available
Feb 08 2010	Es ist zu hell A possible cause for the variable PRESEPT laboratory data was identified as too much background fluorescence in a PCR system. Reanalysis of samples should give a more consistent picture. The main implication might be for 2010 sales, but peer review of PRESEPT data, due Q2, and Abbott results on its m2000 platform in H111 should put Epi proColon back on its commercial track. There are no regulatory implications as this does not affect the CE mark and Abbott will file a separate PMA. Research type: QuickView	Log in to download 2 page note available
Jan 20 2010	Probleme in den Daten Initial data from the PRESEPT study on the bowel cancer test, Sept9, were released on 15 January. One laboratory had a lower detection rate than the others but it seems likely that Sept9 will detect 50-62.5% of colon cancer patients including many patients with curable early stage disease. An audit of the laboratories is ongoing and retesting of samples may occur. Final data should be released by late March. However, 96.5% of positive tests will prove negative on colonoscopy examination. Research type: QuickView	Log in to download 2 page note available

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Peter Knowles
Director, Fyshe Horton Finney