New Biomarkers Detect Pancreatic Cancer

The findings were reported in the February 6, 2004, issue of the Journal of Clinical Cancer Research.

Pancreatic cancer has the highest mortality rate of any solid cancer, with a five-year survival rate of less then 5%. The disease is often very advanced by the time symptoms occur and a diagnosis has been made. However, if detection is made early and the patient is treated with surgery, the rate improves to 15-40%, revealing an unmet need for accurate noninvasive tests that can detect the disease early. A serum test, CA19-9, can be used for monitoring therapy in patients already diagnosed, but there is currently no serum test for the initial diagnosis.

Using mass spectrometry technology called SELDI (surface-enhanced laser desorption ionization) and bioinformatics tools, the researchers analyzed blood samples from 60 patients with pancreatic cancer, 60 sex- and aged-matched patients with nonmalignant pancreatic diseases, and 60 sex- and age-matched healthy individuals. The analysis of the data showed that two protein biomarkers could discriminate pancreatic cancer patients from healthy controls with specificity (true negatives) of 96% and sensitivity (true positives) of 78%. Adding the CA19-9 test to the two-marker panel further improved the test's overall performance. Since the study analyzed patients with surgically respectable cancer, the researchers say it is possible that this marker panel will be diagnostically useful even for those patients who have small cancers.

Leading the research team were Drs. Michael Goggins and Daniel W. Chan, of Johns Hopkins University School of Medicine (Baltimore, MD, USA, www.hopkinsmedicine.org), who used the SELDI ProteinChip technology of Ciphergen Biosystems, Inc. (Fremont, CA, USA; www.ciphergen.com) for the study. Ciphergen and Johns Hopkins have been collaborating since 2000, focusing on the discovery of novel protein biomarkers of various cancers. Ciphergen has an exclusive option to the therapeutic and diagnostic rights to discoveries made under the collaboration, with royalties payable to Johns Hopkins.

Ciphergen Diagnostics Division is focused on the discovery of protein biomarkers and panels of biomarkers and their development into protein molecular diagnostic tests that can improve patient care. The company's Biomarker Discovery Center provides collaborative R&D services for drug toxicology, efficacy, and theranostic assays.

"We believe that novel biomarkers can enable early detection of pancreatic cancer, and this program is one we will be pursuing, in partnership with our collaborators at Johns Hopkins School of Medicine (Baltimore, MD, USA), said Gail Page, president of Ciphergen Diagnostics.




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