Four years ago, researchers in Seattle have identified a protein known as human epididymis protein 4 (HE4) as very effective in distinguishing ovarian cancer from benign ovarian mass and cysts. Since then, other studies have supported these initial findings, including one just published in December 2007 issue of Gynecologic Oncology.
The only evidence available in the market to date, which detects proteins produced by the ovariesCancer>, is CA-125. Y. 'More useful for monitoring patients with known ovarian cancer, to evaluate how patients respond to treatment and to detect recurrence after treatment The problem with CA 125 as a screening test is that it is often elevated in the presence of normal ovaries or benign ovarian cysts and tumors. In addition, the CA 125 is not very high frequency in ovarian cancer early, when it is still highly curable. These two aspects make it almostuseless for research.
As the CA125, HE4 protein is released by ovarian cancer cells and is found in the bloodstream, which can be detected. The HE4 test, which is patented by the Japanese, Inc., Fujirebio Diagnostics, is closer to FDA approval. Because the expression of HE4 ovarian tissue mass is benign or normal ovarian very low, there is a much better potential as a screening test for CA125.
The latest study, led by Dr. RG Moore, showed that HE4was the best single marker for Stage I, or primary ovarian cancer. Another study finding was that the combination of HE4 and CA125 was better. Statistical analysis showed that this combination had a sensitivity of 76.4% and a specificity of 95%, making the combination more accurately than any test alone.
HE4 is not the only biomarker that is being investigated as a screening tool for ovarian cancer. More than 30 people have been evaluated alone or in combination withCA125 by different investigators. Some of the most promising are: mesothelin, M-CSF, osteopontin, kallikrein (s), and soluble EGF receptor. Keep an eye out for these in the following news. It is very likely to have an effective combination of a screening tool for ovarian cancer, known as the "silent murderer" in the next two or three years.
