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DGAP-News: MIDAS Research: Express Mark of MIDAS Research Epigenomics AG (ISIN DE000A0BVT96)


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Shipping note of MIDAS Research Epigenomics AG (ISIN DE000A0BVT96)
Identify the possible source of error in Epigenomics’s PRESEPT study promises rapid study completion
‘A swift solution is in sight and the risk seems to decline, "said the summary of Thomas Schießle, Specialist Analyst MIDAS Research, on the outcome of the review The unexpectedly strong results from a study of the three different Laboratories where the samples were measured PRESEPT cohort.
In addition, the analyst is confident that with The now available knowledge and the announced Measures the way to the final study results in the coming eight weeks and this has paved as planned, the important upcoming medical conferences, and presented for review and publication in scientific journals can be submitted.
Regardless of these academic study and its Results no influence on official procedures such as a future FDA approval or other permits for the house Epi proColon product, the Abbott MS9 assays or tests in the Quest ColoVantage current or future marketing regions.
The fundamentals of the business model of Berlin, the Specialist Analyst, were therefore not in danger, and ‘the original timetable expected after the recent indications hardly suffer ‘, sums up Thomas Schießle together.
Where does this confidence?
The audits of all three participating laboratories, the internal processes at Epigenomics and the Biostatistics Group at the University of Minnesota, conducted as part of the investigation were, according to management were no significant differences in the unambiguous assignment of the samples throughout the entire laboratory process, the Handling the samples during their processing and determine what the explain the observed outcomes could be. Thus, neither handling nor Evaluation errors explain the variations in measurements. Instead, they found massive Notes that there is a – or a combination of several – ‘hardware failure’ could have been that the correct reading of the samples in some Could have prevented lots of the laboratories concerned. A Knowledge, which completely surprised, because all materials used were tested before the start of the PRESEPT study for their suitability and No such effects were not in the other two laboratories still earlier studies conducted by Epigenomics observed.
Yet, it put out that the analytical Instrument of the laboratory with the unexpected findings, a recently published a new version of the device was, while in the two other laboratories used an older version of this instrument was. According to the company-provided the audit team found that this Instrument with which unexpectedly proved to be a few cancer cases could, in several but not all device streams unusually high fluorescence signal was showing, and thus the readout of Test results were falsified. For this source of interference ‘can a valid reading is no longer with the result that these samples be counted as ‘negative results’.
We already know the exact cause?
These fluorescence signals could be installed by Sample containers, which were used for the measurement on this device and / or have been caused by the device itself. It is this Question, namely whether and to what extent these signals for observed low detection rate may be responsible, it is now pursue in the coming weeks. If necessary, the Audit Team those (retention) samples, the potential of this Phenomena are concerned, measured again, thus the amount of rework remain very manageable.
Measures under the guidelines of the Medical Devices Act must have convinced the so Berliners in the present situation for its own product in Europe not be initiated. For if confirm the suspicion of a hardware problem, it is at best, the manufacturer of this hardware to your customers should inform any errors. These producers are already been informed of the observations from the study and at the Troubleshooting involved. And also in the direction of the laboratories, the Epi proColon test kits used, the field with customers, together sensitized to the possible source of error in routine operation ruled out.
So it is understandable to analysts think that if the CEO Geert Nygaard stresses that the marketing of existing on the market Colorectal cancer blood test Epi proColon ‘completely gone according to plan’. For this such remains are researching the cause and treatment in accordance rigorously carried out, and not just the affected samples nachzumessen the streets of the remaining two test laboratories.
In addition to the investigation of the unexpectedly low Detection rate in the affected laboratory will study the recommendation of the Clinical Steering Committee – not least for ethical reasons — also tested a small number of additional cancer cases. These Cancer cases were confirmed only by means of a pathological finding, in December after the last of the batches to be tested in the labs has been sent. The Steering Committee had the clinical testing of this Samples already under the original study plan provided so that the data included in the final data set can be. Statistically, they increase so that the Number of cases and the performance indicators of the Septin 9 test.
So all questions answered?
Not yet! It will take until the end of March 2010, estimates MIDAS analyst, will show up whether the final Evaluation – after any re-measurement – the very positive detection rate Measurements of the Septin 9 respectively 62.5% of cancer cases confirmed increased (rather unlikely) or reduced (rather likely).
In either case, remains the definitive Sensitivity ratio of 50.0% is the target class, thus fulfilling the U.S. Guidelines, achieved. And on the way you are now presented with the Error analysis progressed a long way, there is the MIDAS-Analyst convinced.
05.02.2010 Ad-hoc news, financial news and Press releases transmitted by DGAP. Media archive at http://www.dgap-medientreff.de and http://www.dgap.de