Report from fourth quarter 2011
The interim report for the fourth quarter 2011 was approved by the Board of Directors on 13 February 2011. Please find the interim report and presentation attached.
Highlights from the report:
MCItect®: The first blood based test for early Alzheimer disease (AD)
As the world’s first blood-based prodromal AD gene expression markers, DiaGenic has demonstrated that MCI patients converting to AD within two years can be identified in an MCI population with a prediction accuracy of 74 %, enabling early disease intervention. MCItect® is ready for use in phase II clinical trials. US FDA pre IDE (Investigational Device Exempt) submission of MCItect® planned after verification and validation studies. This documentation will also provide European CE labelling for MCItect®. Upon approval, MCItect® can be used to develop companion diagnostics. MCItect® US FDA PMA (Pre-Market Approval) submission for regular clinical use, thereby also supporting Alzheimer drug sales, after performance of a EU/US prospective trial.
Gene expression test for 18F PET imaging in Alzheimer disease
DiaGenic continue discussions with world leading imaging companies to develop a test that correlates with brain deposits of amyloid in the brain detected by PET (Positron Emission Tomography) imaging. Discussions are progressing. The combination of imaging and blood based tests improves quality of AD management through optimal use of PET imaging.
Parkinson disease: New R&D progress, data presentation in China and interest from Pharma
A DiaGenic whole genome study identifying gene signatures that can detect Parkinson disease with improved accuracy in the important early disease state was presented at the XIX World Congress on Parkinson's Disease and Related Disorders in November 2011. Total accuracy of 88 %, and sensitivity of denovo PD is increased to 85%, while previously only 70% was reported. These data expands substantially the potential clinical utility of the biomarker. Substantial pharma interests in an early disease biomarker for clinical PD trials.
Operating revenue were NOK 0.1 million in the fourth quarter 2011 and NOK 3.1 million for the full year 2011, compared with NOK 1.1 million for both the corresponding periods in 2010. Total operating costs for the fourth quarter in 2011 amounted to NOK 9.4 million and NOK 40.1 million for the full year 2011, compared with NOK 11.6 million and NOK 43.6 million in the corresponding periods in 2010. Comprehensive income totalled NOK -8.7 million for the fourth quarter in 2011 and NOK -34.8 million for the full year 2011, compared with NOK -9.9 million and NOK -41.8 in the corresponding periods in 2010. The company’s cash and cash equivalents totalled NOK 58.9 million at 31 December 2011.
Post quarter outlook
- Execute on the companion diagnostic strategy, closing R&D agreements with pharmaceutical and imaging companies within the CNS field.
- Initiating new US collaborations to expand our Alzheimer biobank supporting the development of an early (prodromal) AD test
- DiaGenic’s current strategy for entry into the US Alzheimer diagnostic market is through a FDA PMA application. This implies execution and readout of calibration, verification and validation studies.
Attachments: The interim report and presentation
Erik Christensen, CEO
Telephone: 47 95939918
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