OSLO, Norway--(BUSINESS WIRE)--Regulatory News:
DiaGenic (OSE:DIAG) announces results from the calibration study for MCItect®, a blood based diagnostic test for Alzheimer’s disease in the pre-dementia stage. In a patient population of 157 patients diagnosed with amnestic mild cognitive impairment, MCItect® demonstrated a total prediction accuracy of 75% in detecting patients converting to Alzheimer’s disease dementia within two years.
The study included 157 patients from 19 centers in Europe and the U.S. diagnosed with amnestic mild cognitive impairment, MCI, that either remained stable or progressed to Alzheimer’s disease dementia during a two-year period. The primary goal of the study was to verify a gene expression test that predicts which patients remain stable and which progress to Alzheimer’s disease dementia within two years, based on a larger and more ethnically diverse patient population. The total prediction accuracy of this enhanced version of MCItect® was 75%, with 75% sensitivity and 73% specificity. This result is based on the total study population, including sixteen statistical outliers of which at least six were considered potentially misdiagnosed.
In a subset of patients for which ApoE genotyping was available, ApoE genotype in itself was not a predictor of conversion from MCI to AD dementia. However, among the patients with at least one ApoE 4 allele (n=25), MCItect® predicted conversion to AD dementia within two years with a total accuracy of 88%.
“This calibration study is based on a significantly larger and more geographically representative patient population than previous studies on MCItect®,” said Paul de Potocki, CEO of Diagenic. “The next major step in the development of MCItect®, following in-house technical verification studies, is a validation study to enable regulatory clearances and commercialization. Such study will require a strategic partnership or additional funding of DiaGenic”.
DiaGenic’s second key product candidate AMYtect™ aims to detect elevated brain amyloid load, a condition recognized to be strongly associated with Alzheimer’s disease. The clinical phase of a study examining the correlation between a blood based gene expression test and brain amyloid PET imaging has been completed. In the study, 100 patients have been included and brain amyloid PET scans using GE Healthcare’s flutemetamol tracer have been performed. Analysis of data is ongoing and top line study results are expected during the month of October.
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
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