DiaGenic provides update on AMYtect™ study
DiaGenic reports intermediate results from an exploratory study that examines the correlation between gene expression in blood and brain amyloid PET imaging. In an initial patient population of 100 patients, a correlation between brain amyloid load as measured by brain PET imaging and gene expression in peripheral blood was established. Additional data analyses and possibly additional patients are required to determine the degree of correlation and test accuracy.
The primary goal of this exploratory study is to identify a gene expression signature which detects whether an individual has normal or elevated levels of amyloid in the brain as determined by PET imaging. The subsequent goal is to develop an IVD multivariate index assay test, AMYtect™. The study has so far included 100 patients from clinical centers coordinated by Lund University in Sweden, of which 85 were diagnosed with suspected mild cognitive impairment and 15 were healthy controls. Blood samples were collected and brain amyloid PET scans using GE Healthcare’s investigational [18F] Flutemetamol tracer were performed for all patients. Based on available study data, the preliminary results show a correlation between gene expression in blood and PET imaging results with a specificity of 84 % and a sensitivity of 74 % using the PET imaging as the reference.
“This is an exploratory gene signature candidate that requires improvement and verification prior to development into a test for clinical use. We are still awaiting numerical data from the semi-quantitative PET imaging analysis as well as clinical information related to chronic disorders and medication for the study population. These additional data may influence data modeling, patient outlier classification and the eventual final accuracy of the IVD test”, said Paul de Potocki, CEO of Diagenic. “The study and the robustness of final results will also benefit from the inclusion of additional patients”.
DiaGenic will evaluate to include up to 50 additional patients in the study and expects to report final study results during the fourth quarter this year.
For more information, contact:
Paul de Potocki, CEO at DiaGenic, telephone: +47 2324 8950
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