Report from fourth quarter 2012

Continued product development progress focused on Alzheimer’s disease,
new industry guidelines support implemented strategic direction

The interim report for the fourth quarter 2012 was approved by the Board of Directors on 14 February 2012. Please find the interim report and presentation attached.

Highlights from the report:

  • The product development activities required for CE marking of new ADtect® and MCItect® are progressing as planned. Both products are undergoing technical verification studies and calibration trials. Final confirmatory validation studies will be performed during the spring, allowing CE marking of both products around mid-2013
  • The collaborative clinical study with GE Healthcare and Lund’s University for AMYtect™ is progressing as planned. An interim analysis is planned for the summer and results are expected in Q3 this year
  • DiaGenic is preparing a pre-IDE meeting with the FDA during the summer, with the aim to confirm the clinical and regulatory path to U.S. approval and commercial launch of MCItect®
  • DiaGenic, together with its financial advisors, are in dialogue with existing shareholders and potential new institutional and industrial investors with the aim to complete an equity issue. The indicative size of the issue is NOK 30 million, which will provide funding for its operations at least until end of first quarter 2014. The Company’s largest shareholders have given positive indications regarding their participation in an issue at the current market price level
  • Q4 2012 pre-tax earnings were NOK -10.9 million compared with NOK -8.7 million in Q4 2011.
    The cash balance was NOK 18 million at the end of the quarter, which is according to plan. Current cash balance is sufficient to fund the Company until early May 2013

Significant events after the end of the period:

  • In February, the FDA issued new draft industry guidelines regarding drug development for Alzheimer’s disease (AD). The FDA emphasizes the value of identifying and studying patients with early stage Alzheimer's disease, and highlights the need for biomarkers to identify AD patients in the mild cognitive impairment (MCI) pre-dementia stage of the disease
  • DiaGenic’s study on the ‘Prediction of MCI due to AD in an amnestic MCI population’ has been accepted for publication in the Journal of Alzheimer’s Disease
  • DiaGenic has signed an agreement with a major U.S. university that provides access to additional U.S. patient samples and clinical data enabling validation of DiaGenic’s MCItect® product
  • As a consequence of the strategic decision to focus on product development targeting Alzheimer’s disease, DiaGenic has terminated research activities and related employment positions outside of this focus. These measures will reduce the Company’s cost base by approximately NOK 3 million in 2013


DiaGenic´s goals for the next 12 months include:

  • To secure appropriate financing of the Company
  • To deliver on the near-term milestones related to product development:
    • CE marking of new ADtect® and MCItect® in Europe
    • Presentation of results from the on-going clinical study with GE Healthcare to identify a blood-based IVD test correlating with brain amyloid PET imaging
    • Conduct a pre-IDE meeting with the FDA to confirm the requirements for U.S. regulatory clearance
  • To enter into additional collaborative agreements related to Alzheimer's disease with major pharmaceutical companies
  • Proactively and in parallel evaluate the alternatives for strategic development providing optimal shareholder value following achievement of above product portfolio milestones

 Attachments: The interim report and presentation


Paul de Potocki, Chief Executive Officer

Telephone: 47 2324 8950


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:

About Us

NEL ASA is a leading global supplier of hydrogen technology for industrial / energy purposes, and has made over 500 deliveries in more than 50 countries. The company's main products are hydrogen production plants based on water electrolysis, complete hydrogen stations for transport and renewable energy storage solutions. The company has its roots from the hydrogen activities of Norsk Hydro, which dates back to 1927. The company also has a number of patents related to tests for early detection and diagnosis of diseases.