Early diagnosis and calculating the risk of ovarian cancer in women by combining the results of two biomarkers HE4 & CA125

Aaso Raoofi1,*, Adam Molner1, Fereshteh Pourlotfi1, Tatyana Danylchenko1

1Klinisk Kemi, Sahlgrenska University Hospital, Göteborg, Sweden

Introduction: Ovarian cancer is the second most common type of gynecological cancer and is highly frequent in industrial countries such as the Scandinavians,which has the highest rates of patients in the world.Almost 70–80 % of the patients relapse after the first treatment.Almost 90 % of all ovarian cancers are epithelial.

The cancer can be associated with age,heredity,anemia,abdominal pain and distension,rectal bleeding,postmenopausal bleeding,appetite/weight loss.The diagnosis process currently starts with a physical examination,CA125 test in blood and transvaginal ultrasound.Symptoms for ovarian cancer can appear in early stages of the disease,it is therefore very critical to recognize them.Nowadays the majority of patients are diagnosed in the late stages.

Objectives: CA125 itself cannot be used for a safe clinical diagnosis because it does not elevate in all of the patients with ovarian cancer.

The HE4 biomarker is found to increase the sensitivity of CA125 and therefore the chance of detecting the cancer in earlier stages.This biomarkers usage is an important progress in terms of diagnosis,treatment,monitoring and management of ovarian cancer patients.

Methods: After validating and introducing the new methods for CA125 and HE4 which are presented by Roche and run on Cobas system,the results can be assessed by an algorithm called ROMA (Risk Of Ovarian Malignancy Algorithm),which combines the results of CA125 and HE4 and helps with the risk stratification of women with a pelvic mass.


Results: The new reagents/analysis method to the Cobas system has been introduced,validated and accredited by the dep. of clinical chemistry lab. Sahlgrenska.A comparison of the results from the Cobas instrument at Sahlgrenska and the results from the chemistry lab in both Lund and Halmstad has also been made.

Conclusion: By introducing HE4 and CA125 to the Cobas system,we are able to perform the tests 24/7,all days of the year. We are going to help a faster an safer monitoring av the possible patients in the region.

Keywords: Biomarker development, Cancer, Method