Biohit Oyj - Company Announcement

NEW DELAYS IN THE FDA APPROVAL PROCEDURE FOR BIOHIT'S PEPSINOGEN I AND II TESTS

BIOHIT OYJ STOCK EXCHANGE RELEASE ON 25 NOVEMBER 2008 AT 7:00 PM

NEW DELAYS IN THE FDA APPROVAL PROCEDURE FOR BIOHIT'S PEPSINOGEN I AND II TESTS 

The US Food and Drug Administration (FDA) has not approved the further          
clarification related to Biohit's application for the GastroPanel Pepsinogen I  
and II tests. Biohit delivered this clarification to the FDA in October this    
year. According to FDA, the clarification contains insufficient information. To 
continue the process, more comprehensive research data and a new submission is  
required.                                                                       

As per FDA's request, two patient studies have been made in the USA. The        
research data acquired, however, proved to be insufficient according to FDA     
criteria.                                                                       

The FDA has already earlier granted authorisation to GastroPanel's Gastrin-17   
and Helicobacter pylori antibodies tests. No other company has previously       
received FDA approval for Pepsinogen I and II. Biohit had to supplement its     
original application in the United States with two studies that compared the    
results of Biohit's Pepsinogen I and II to the histology of several biopsies    
taken through gastroscopy (a normal finding or atrophic gastritis, - i.e. loss
of glands and function of the stomach mucosa). In other countries, patient
trials with GastroPanel have given good results. 

Biohit will continue the authorisation process by making a plan to get further  
clarifications that will meet the requirements of FDA.                          


Biohit Oyj                                                                      
Osmo Suovaniemi                                                                 
President & CEO                                                                 


Further information:                                                            
Osmo Suovaniemi, M.D., Ph.D., Professor                                         
President & CEO                                                                 
Tel: +358-9-773 861                                                             
GSM: +358-40-745 5605                                                           
Email: osmo.suovaniemi@biohit.com                                               

Distribution:                                                                   
Helsinki Exchanges                                                              
Central storage facility (www.oam.fi)                                           
Press                                                                           
www.biohit.com                                                                  


About Biohit Oyj                                                                

Biohit Oyj develops, manufactures and markets liquid handling products and      
diagnostic test systems for use in research, health care and industrial         
laboratories.                                                                   

Liquid handling products include electronic and mechanical pipettes and         
dispensers, and disposable tips, as well as pipette maintenance and calibration 
services. Diagnostics business comprises products and analysis systems for      
diagnosing, screening and prevention of gastrointestinal diseases, e.g. the     
blood-sample based GastroPanel and GastroView, for diagnosing diseases of the   
stomach and associated risks, as well as quick tests for the diagnosis of       
lactose intolerance, H. pylori infection and fecal occult blood.                

Biohit Oyj is headquartered in Finland. Biohit has subsidiaries in France,      
Germany, the UK, Russia, China, Japan and the USA. Additionally, Biohit's       
products are sold by approximately 450 distributors in 70 countries. Biohit's   
share (BIOBV) is quoted on NASDAQ OMX Helsinki.                                 

Read more at www.biohit.com