| Four years ago, Seattle researchers identified a | | | | Fujirebio Diagnostics Inc., is inching closer to FDA |
| protein, known as Human Epididymis Protein 4 | | | | approval. Because expression of HE4 by normal |
| (HE4), as being highly effective in distinguishing | | | | ovarian tissue or benign ovarian masses is very |
| cancer of the ovary from benign ovarian masses | | | | low, it has far better potential as a screening test |
| and cysts. Since then additional studies have | | | | than CA125. |
| supported these initial findings, including one just | | | | The latest study, headed by Dr. RG Moore, |
| published in the December 2007 edition of the | | | | showed that HE4 was the single best marker for |
| journal Gynecologic Oncology. | | | | Stage I, or early, cancer of the ovary. An |
| The only commercially available test to date, that | | | | additional finding in the study was that combining |
| also detects proteins elaborated by ovarian | | | | HE4 and CA125 was better. Statistical analysis |
| cancer, is CA-125. It is most useful for following | | | | showed that this combination had a 76.4% |
| patients with known ovarian cancer, to assess | | | | sensitivity and 95% specificity, making the |
| how well patients are responding to treatment | | | | combination more accurate than either test alone. |
| and to detect recurrence after treatment. The | | | | HE4 is not the only bio-marker that is being |
| problem with CA125 as a screening test is that is | | | | investigated as an ovarian cancer screening tool. |
| it very often elevated in the presence of normal | | | | More than 30 others have been evaluated alone |
| ovaries or benign ovarian cysts and tumors. In | | | | and in combination with CA125 by different |
| addition, CA125 is not elevated very often in early | | | | investigators. Some of the most promising include: |
| cancer of the ovary, when it is still highly curable. | | | | mesothelin, M-CSF, osteopontin, kallikrein(s), and |
| These two issues, render it almost useless for | | | | soluble EGF receptor. Keep an eye out for all of |
| screening. | | | | these in upcoming breaking news. It is highly likely |
| Just like CA125, HE4 protein breaks free from | | | | that we will have an effective screening tool |
| ovarian cancer cells and finds itself into the | | | | combination for the ovarian cancer, widely known |
| bloodstream where it can be detected. The HE4 | | | | as the "silent killer", within the next two to three |
| test, which is patented by Japanese based | | | | years. |