OSLO, Norway--(BUSINESS WIRE)--Regulatory News:
DiaGenic ASA (OSE:DIAG): DiaGenic today reports on the finalization of data collection and database lock of a blinded study in a Norwegian cohort of 80 patients with familial Parkinson’s disease (PD). The majority of these patients are carrying a mutation in the parkin 8 gene (also called LRRK2) that significantly increases the risk of developing PD. Patients recruited from St Olavs University Hospital under the lead of Principal Investigator Professor Jan Aasly are all LRRK2 mutation carriers with or without the disease or healthy relatives. Unblinding of the study is set to the May 16th and analysis and reporting is expected to be completed during summer 2012.
As part of the overarching program on development of diagnostic biomarkers for PD, the objective of the study is to identify a biomarker for individuals at risk of developing the disease using material from LRRK2 individuals and relatives. The LRRK2 study is unique being the first blood based RNA analysis in pre symptomatic PD. The study is also expected to allow independent validation of DiaGenic’s European multicentre study that previously this year reported a high accuracy (88%) in PD patients reported February 8th 2012.
The collection of data from the Norwegian individuals with this rare mutation has been ongoing at St. Olav`s University Hospital in Trondheim, Norway, since 2009 and includes collection of blood for gene signature analysis, clinical variables and imaging of the brain. By taking blood samples from individuals with LRRK2 mutations and identifying a gene signature before signs of the disease occur, a general blood based diagnostic test for early PD can be developed.
The gene analyses of 96 samples including technical controls and samples of 82 participants from families with a LRRK2 gene mutation are performed on an Illumina whole genome platform and aims to identify disease related gene probes (i.e. gene transcripts) for disease specific diagnostic models. The gene analyses were completed May 7th and the study now enters into the phase of final bioinformatical analysis.
Professor Jan Aasly, Dept Neurology, St Olavs University Hospital, Trondheim, Norway comments: “This unique study represents an opportunity to make new scientific discoveries in Parkinson`s Disease. Should we be able to identify a gene signature that is present before the onset of neurological signs in PD, in this form of familial PD, then we may be one step closer to identifying a diagnostic test for pre symptomatic PD.”
DiaGenic CEO Dr Henrik Lund said: “We are very pleased collaborate with St. Olav’s University Hospital and Professor Aasly. We are especially grateful to the families that are committed to support scientific advancements in PD. With their support we are in a good position to start identifying novel biomarkers that in DiaGenic’s product development programs can mature into diagnostic tools to support early diagnosis and development of new drugs to treat PD. DiaGenic is committed to develop novel diagnostic tools for severe disorders, especially in PD and Alzheimer’s disease.”
About PD
Parkinson’s disease (PD) is the second most common neurodegenerative disorder after Alzheimer’s disease with more than 5 million patients worldwide, whereas 1 million are in the US. PD is a disorder of the central nervous system that results from the loss of cells in various parts of the brain. No cure is yet available, but several pharmaceutical companies are currently developing medicines many of which target disease modification in PD. There is no objective test for Parkinson's, so the rate of misdiagnosis can be relatively high, especially when the diagnosis is made by a non-specialist at an early stage of the disease.
PD research in DiaGenic
PD is an additional therapy area for DiaGenic together with Alzheimer’s disease, initially funded by a grant from Michael J. Fox Foundation in US, subsequently from the Norwegian Research Council from 2010 onwards
About DiaGenic’s European multicenter Parkinson study
DiaGenic have as a core asset high quality large volume biobanks with biomaterial relevant for mRNA gene signatures can provide access to high quality patient cohorts in key neurodegenerative diseases. The 900 patient large Parkinson biobank was established in 2008 in collaboration with several Neurospecialist centres across Europe.
About DiaGenic ASA
DiaGenic seeks to create value for patients, partners, and investors by developing innovative and more patient friendly methods for early detection of diseases utilizing DiaGenic’s unique concept. The concept implies that a disease evokes systemic responses in the blood unique for the disease, and which can be measured by using blood samples.
DiaGenic is a world leader in identifying these gene expression signatures in peripheral blood and is focused on the development of biomarkers in the field of Alzheimer’s disease and Parkinson’s disease. DiaGenic’s Alzheimer’s disease development program includes the CE marked diagnostic test ADtect®, for detection of mild to moderate Alzheimer’s disease, and MCItect®which is under development for identifying patients with very early stages of Alzheimer’s disease (prodromal AD).
DiaGenic’s concept is protected through an extensive patent portfolio. DiaGenic promotes its products and services towards leading pharmaceutical, imaging and diagnostic companies. DiaGenic is located in Norway and listed on the Oslo Stock Exchange. For more information please visit: www.diagenic.com
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