DiaGenic provides update on key clinical programs
DiaGenic announces that the validation study for MCItect®, a blood based diagnostic test for Alzheimer’s disease in the pre-dementia stage, has failed to reach the study goals. Consequently, DiaGenic will not pursue CE-marking or U.S. trials with the current version of MCItect®. The clinical study for the company’s other key product AMYtect™ has successfully recruited 100 patients and will enter the analysis phase in August.
In the development of MCItect®, DiaGenic reported results on July 17th 2012 from a 60-patient study demonstrating a total prediction accuracy of 74% in detecting patients converting from mild cognitive impairment to Alzheimer’s disease dementia. Utilizing an improved assay methodology and instrumentation, a separate non-overlapping subset of genes increased the prediction accuracy to 81%.
The current validation study for MCItect® included 84 patients from both Europe and the U.S. diagnosed with amnestic mild cognitive impairment (aMCI) that either remained stable or converted to Alzheimer’s disease dementia during a two-year period. The primary goal of the study was to validate a gene expression test to identify those aMCI patients converting to Alzheimer’s disease dementia within two years, with prediction accuracy above 75%.
“Final study results are still in progress, but it is clear that the current version of MCItect® has not demonstrated the diagnostic accuracy we deem is required for CE-marking, US studies and commercialization,” said Paul de Potocki, CEO of Diagenic. “We will continue a detailed analysis of the study results, including the possible influence of differences in ethnicity, age and gender in this study population compared to earlier studies. A back-up program for a modified version of MCItect® has been prepared and may be quickly initiated”.
DiaGenic’s second key product AMYtect™ is in advanced exploratory stage of development. The product aims to detect patients with brain amyloid, a condition recognized to be strongly associated with Alzheimer’s disease. The ongoing study examines the correlation between a blood based gene expression test and brain amyloid PET imaging. In the study, 100 patients have been included and brain amyloid PET scans using GE Healthcare’s flutemetamol tracer have been performed. Analysis of patient material and data is planned to commence in August.
Contact:
Paul de Potocki, Chief Executive Officer
Telephone: 47 2324 8950
e-mail: paul.depotocki@diagenic.com
Paul de Potocki will be traveling to Oslo and not awailable before 11.30 AM CET / 29-July-2013
For any questions please contact: Magnus Sjögren, Chief Medical Officer at DiaGenic, telephone: +47 2324 8950
About DiaGenic ASA
DiaGenic is an innovative Norwegian diagnostic company that seeks to create value for patients, partners and investors by developing innovative and patient friendly in vitro diagnostic (IVD) products for early detection of diseases. The company’s proprietary concept implies that a disease evokes systemic responses in the blood unique for the disease, and which can be measured by using a blood sample. DiaGenic is a world leader in identifying gene expression signatures in blood and is focused on the development of IVD biomarker products in the field of Alzheimer’s disease. The company protects its technology through an extensive patent portfolio. DiaGenic is listed on the Oslo Stock Exchange. For more information please visit: www.diagenic.com