Ovarian cancer remains the leading cause of cancer death from gynecologic origin and the 4th cause of cancer death in women worldwide. In Europe, the mortality rate is between 3.6 and 9.3 to 100,000 women. If an early diagnosis is being established, the prognosis is very good. Unfortunately, 70% of cases the diagnosis is established in advanced stages when the survival rate is very law, only 10-30% of these patients surviving in one year.

Symptoms of ovarian cancer are related to the presence of adnexal formations and are often vague and unspecific. The main purpose of the diagnostic evaluation of such formations is to determine if it is benign or malignant. It is estimated that in the U.S. 5-10% of women resorting recur to a surgical procedure for a suspected ovarian cancer, which is confirmed in 13-21% of cases.Since most of them are benign adnexal formations is very important to be able to determine preoperatively if a patient has an increased risk of ovarian cancer or not and to address an appropriate therapeutic attitude. This risk is assessed value and good positive correlation with clinical data's value of the tumor marker CA 125 (cancer antigen 125) and ultrasound examination.



To improve the risk assessment for ovarian cancer and to decrease its mortality rate there have been created two new diagnostic tests. In September 2009, the Food and Drug Administration (FDA) has approved the test OVA1 ™ - the first blood test that, before exploratory surgery or biopsy, may help the doctor to determine whether a woman with an adnexal tumor is malignant or not , with a high sensitivity or not, even if radiological exporarile does indicate or not malignancy. The test is developed by Vermillion Inc. company.  A molecular diagnostic company, in cooperation with the firm Quest Diagnostics - the world leader in cancer diagnosis. Ouest Diagnostics - long-term investor in research and development OVA1 ™ technology - holds the exclusive right to market clinical reference laboratories in the U.S. for the next three years.



OVA1 ™ test is a qualitative in vitro diagnostic, which provides an index obtained by combining the results of five immunological tests using a patented algorithm, the numerical score achieved (between 0-10) indicating the risk of malignancy. This test indicated that 18 year old women and eve older ones who show an adnexal tumor and who were scheduled for surgery have not addressed the oncologist yet.  The test uses the following biomarkers:

transthyretin (TT or prealbumina)  apolipoprotein A1 -A2- microglobulin ransferin  CA 125 (cancer antigen 125)

The test should not be used without clinical and radiological assessment and should not be recommended as a screening test. The permitting process OVA1 ™ test, the FDA evaluated the results of a multicenter clinical trial, prospective, double blind, which included 27 different locations in terms of population.  Vermillion Inc. company. Gynecologists Society of Oncology prize for a poster presented at the 38th annual meeting of the society on the issue of cancer in women in 2007 - entitled "Independent prospective validation of a panel of markers to differentiate benign from malignant pelvic formations. Results showed that the test correctly identified 84% of ovarian cancers, compared with only 33% identified by standard diagnostic methods.

In early February 2010, Abbott - a global leader in vitro diagnosis - the FDA approval under a new diagnostic test useful in monitoring patients with epithelial ovarian cancer - Architect HE4 (Human Epididymal Protein 4). If you receive approval, this important immunological test will automatically be the first test of this type.
HE4 is a biomarker for detecting ovarian cancer, with a very low expression in normal ovarian tissue. Proper expression at the cellular level, high levels of HE were detected in the sera of four patients with ovarian cancer. HE 4 has a sensitivity of 70-80% at a specificity of 95-96% in diagnosing ovarian cancer.

Repeated determinations of HE4 and percentage growth estimates are useful in monitoring disease evolution and the emergence of the appellants in patients with epithelial ovarian cancer.This test should not be used as a screening test and no monitoring is recommended in patients with other types of ovarian tumors (mucinous, germ cells) - in which no growth of HE4. 4 Studies show that HE is more sensitive than CA 125, CA125 + HE4 combination - is more sensitive than either marker alone, and for stage I, HE4 alone is the most sensitive marker.
Architect analyzer (Abbott) has the possibilities to carry out both determinations and to estimate the risk of ovarian cancer in women, depending on the status of pre-or post-menopause, by an algorithm called the Risk of Ovarian Malignancy ROME = Algorithm, set within a multicenter clinical trial, prospective, double blind, obtaining a predictive index: premenopausal - ROME 7.4% - low risk,  7.4% - high risk  menopause - ROME 25.3% - low risk,25.3 - risk.