OSLO, Norway--(BUSINESS WIRE)--Regulatory News:
DiaGenic's (OSE:DIAG) blood sample based Alzheimer's disease test has proven successful in a clinical study released today. DiaGenic is the first to diagnose Alzheimer's disease from a blood sample at such an early stage of the disease.
The results of the pilot study now being made public were presented at the 4th Conference Clinical Trial on Alzheimer's disease (CTAD) meeting in San Diego, California today. Upon further product development and regulatory approval, DiaGenic's tests have the potential to significantly reduce costs related to the development of Alzheimer treatment.
Two diagnostic tests are currently being developed. One aims to identify the patients with mild cognitive impairment who will develop Alzheimer's disease within the next two years. This test will be suitable for patient inclusion into clinical trials in the pre dementia stage of AD. The second test aims to demonstrate disease progression and may be used to monitor treatment effects of new drugs in trials.
129 patients participated in the study in which DiaGenic successfully identified blood-based biomarkers consistent with Alzheimer's disease in patients with the very first symptoms of cognitive impairment. The study demonstrated an accuracy of 74 per cent, which is considered high at this challenging stage of the disease. Applied as a selection tool, the DiaGenic test has the potential to reduce the necessary size of the clinical trials by 30-40 per cent through optimal identification of patients.
DiaGenic also reported the first blood based expression signature to monitor disease progression. The signature showed 90% sensitivity in a subset of patients with very mild cognitive symptoms.
"The study confirms the potential of DiaGenic's blood based diagnostic test for early detection of Alzheimer's disease. Early diagnostics is crucial for the development of better treatment for a serious and fast growing condition", said M.D. Ph. D Erik Christensen, CEO of DiaGenic.
In a smaller subset of samples where spinal fluid protein biomarkers was available the test demonstrated equal performance as the invasive CSF tests currently in use. The proof of concept, as the first in the world, is established for this blood based early Alzheimer's disease test.
The new signature, combining identified genes and the bioinformatics tool, has demonstrated a robust diagnostic power, also when applied on samples from DiaGenic's former clinical studies at the dementia stages of Alzheimer's disease.
"These findings demonstrate the strengths of DiaGenic's technology and expertise within blood-based CNS biomarkers," Dr Christensen added.
"The new study also shows that DiaGenic is ahead of competitors. Our AD concept is IP protected with patents in the US, Europe and in several other countries. A broad patent application including the above findings has now been filed", said Erik Christensen.
The study was partly funded by Pfizer Inc., the market leader for Alzheimer's therapeutics.
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