DiaGenic ASA: DiaGenic Reports High 85% Accuracy for Blood Based Diagnosis in Early Parkinson Patients in European Multicenter Study

Regulatory News:

The initial findings from DiaGenic (OSE:DIAG) sponsored prospective European multicenter Parkinson study is reported. The initial read out of the first subcohort of 79 PD patients and 75 matched healthy controls with no neurodegenerative disease, shows a diagnostic accuracy of 85% in early disease patients while overall accuracy was 88% across all stages.

The preliminary results of the biomarker development program in Parkinsons’s Disease (PD) were presented at the 19th World Congress on Parkinson’s Disease and Related Disorders in Shanghai in November last year. DiaGenic reported that their gene expression data contained information that can be used to classify PD with high average accuracy in peripheral blood.

The company today reports that further analysis of gene expression data from the whole genome study of the initial cohort has demonstrated a model accuracy of 88% (89% sensitivity and 87% specificity) using a set of around 700 probes. In the clinically important group of early PD, previously untreated patients, which represent particular challenges in clinical diagnosis (de novo PD), a high 85% sensitivity was demonstrated.

79 PD patients, whereof 27 were early, non drug treated patients (de novo PD), and 109 matched neurodegenerative healthy controls were included in the study.

All patients were diagnosed at each site by a movement disorder specialist and met the modified United Kingdom Parkinson’s Disease Society Brain Bank clinical diagnostic criteria for PD. The healthy control samples were included at the same clinical sites as the PD patients. They were cognitively healthy and had no apparent symptoms of any neurodegenerative disease. ”PD-like” clinical cohorts were also included like essential tremor, progressive supranulear palsy and multiple system atrophy. DiaGenic’s biobank currently contains approximately 900 recruited Parkinson patients from Norway, Sweden, Germany and Italy.

Whole genome screening was performed on the Illumina platform (47,000 probes) to identify disease related gene probes (i.e. gene transcripts) and to develop disease specific diagnostic models. In total more than 11,000 probes were analyzed in blood and around 2,000 were impacted by PD.

DiaGenic CMO, Dr Magnus Sjogren said:” Early diagnosis of PD is challenging and a clinical accuracy of below 60% is often reported among non specialists. Leading experts agree that there appears to be a consensus amongst clinicians that a blood test with high accuracy that is risk-free, simple to use would be very useful in routine diagnostic examinations. We are excited to see accuracy early on using a whole genome approach, exceeding 85% in Parkinson disease.”

DiaGenic CEO Dr Erik Christensen said: "These findings are very encouraging and build a solid foundation for further development of a blood based biomarker for diagnosing PD at early stages together with a partner. Our study results are being discussed with pharmaceutical companies developing PD therapeutics. They express a need for an accurate identification of PD patients when developing new disease modifying drugs. We are happy to note that these companies state that DiaGenic is in the forefront of this field and that our biobank with serial samples from PD patients is unique.”

About DiaGenic ASA

DiaGenic is an innovative Norwegian biotechnology company that seeks to create value for patients, partners, and investors by developing new and more patient friendly methods for early detection of diseases. DiaGenic is currently a world leader in analyzing gene expression signatures related to disease in easily available clinical samples such as peripheral blood. This unique method is based on the principle that even when a disease is localized at a specific part of the body, secondary responses, which are also characteristic of the disease, can be measured in other parts of the body. DiaGenic has developed and CE marked two blood based diagnostic tests, BCtect® for early breast cancer detection and ADtect® for early detection of Alzheimer’s Disease. The company protects its technology through an extensive patent portfolio. DiaGenic promotes its products towards leading pharmaceutical and imaging companies, and towards clinicians. DiaGenic is listed on the Oslo Stock Exchange. For more information visit www.diagenic.com

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