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Press Release 16.12.2003
Contribution to Assessment of Cervical Cancer.

Heidelberg, Germany; Copenhagen, Denmark, Dec. 16, 2003. DakoCytomation will launch a new diagnostic test within the next weeks that may improve early detection of cervical cancer in conventional and liquid-based cervical smears. The test was co-developed with mtm laboratories and is based on the CINtec™technology licensed from mtm laboratories. According to WHO 510,0001 yearly cases of cervical cancer are reported worldwide. Chances for complete recovery are nearly a 100% when detected early. Cervical cancer is the second largest cause of female cancer mortality worldwide with 288,0002 deaths yearly.

The CINtec™p16ink4a Cytology test identifies elevated levels of the p16 protein in cervical cells. Recent clinical studies have indicated that a high level of p16 in cervical cells seem to be correlated with an underlying persistent HPV infection and thereby presence of a pre-cancerous or cancerous cellular change.

An operation is less invasive when the cancer is detected early. The p16 test forms a potential piece of the puzzle that may lead to an improved treatment of cancer patients.

Preliminary results show that DakoCytomation's p16 test may become a valuable supplement to the traditional PAP test. Early detection of the female population using the PAP test already has contributed to a significant reduction of cervical cancer mortality in the last decades. Data from the Nordic countries3, for instance, has shown a reduced mortality from cervical cancer by approximately 60%.

There is, however, still a high number of false-negative and false-positive PAP test results, which in part is due to a rather subjective evaluation approach. The new p16 test from DakoCytomation takes complexity out of testing by clearly coloring cells having high probability of being pre-cancerous or cancerous.

"We are excited about the potential diagnostic value of p16 and we already see a lot of interest in the market. Each year 150 mio. PAP tests are performed worldwide and that makes it a market potentially 5 times as large as our current core market: cancer testing on tissue" says Jes Østergaard, CEO and President of DakoCytomation. "As we already visit the labs where the tests are performed expansion into this market is a logical move and in line with our strategy."

DakoCytomation will market and sell the CINtec™p16ink4a Cytology kit for both manual and automated use. The test was developed in collaboration with mtm laboratories AG based in Heidelberg, Germany.

1,2 World Health Organization
3 http://ncu.cancer.dk

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