Report from fourth quarter 2012

2/15/2013 2:00 AM EST

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 AMYtectT 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

Outlook

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
Contact:

Paul de Potocki, Chief Executive Officer

Telephone: 47 2324 8950

e-mail:  
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 pleas