The OVDx™ Test and Detecting Ovarian Cancer
Provista Diagnostics is presently developing a simple, blood test to aid in the early detection of Ovarian Cancer called OVDx™.
Ovarian Cancer has the highest mortality rate as a direct consequence of the lack of early reliable and accurate detection test methods.
Women with a personal history of breast cancer or with a family history of breast or ovarian cancer are at an increased risk for developing ovarian cancer. Women over the age of 45 are also more likely to develop the disease than younger women.
If detected in the early stages, the ovarian cancer survival rates are quite high; as high as 93%. For a higher survival rate, ovarian cancer must be detected before it spreads beyond the ovaries into the other organs of the body. Sadly, less than 20% of cases are detected in its early stages because the symptoms in the early stages are minimal and because invasive surgery is required to make a definite diagnosis.
As the disease is rarely diagnosed in the early stages when a total recovery is possible, the outcome of treatment is generally poor -- 76% of patients are diagnosed with the disease while in the advanced stages and consequently survive only up to 1 year with less than 45% living beyond the 5 year survival mark.
Provista anticipates its clinical trials to be completed by early 2013 and, if successful, making the OVDx Test available to the public as a CLIA compliant Laboratory Developed Test.
Women’s Reproductive Cancers: Facts
Women’s reproductive cancers are also sometimes referred to as estrogen-driven or associated cancers. They only affect women and the leading three types of reproductive cancers are cervical, endometrial/uterine and ovarian. The following definitions and statistics are from the National Cancer Institute:
Cervical Cancer: Cancer that forms in tissues of the cervix (the organ connecting the uterus and vagina). It is usually a slow-growing cancer that may not have symptoms but can be found with regular Pap tests (a procedure in which cells are scraped from the cervix and looked at under a microscope). Cervical cancer is almost always caused by human papillomavirus (HPV) infection. There were an estimated 12,200 new cases diagnosed and 4,210 deaths from cervical (uterine cervix) cancer in the United States in 2010.
Endometrial/Uterine Cancer: Cancer that forms in the tissue lining the uterus (the small, hollow, pear-shaped organ in a woman's pelvis in which a fetus develops). Most endometrial cancers are adenocarcinomas (cancers that begin in cells that make and release mucus and other fluids). Additionally, uterine sarcoma is a rare type of uterine cancer that forms in muscle or other tissues of the uterus (the small, hollow, pear-shaped organ in a woman's pelvis in which a fetus develops). It usually occurs after menopause. The two main types are leiomyosarcoma (cancer that begins in smooth muscle cells) and endometrial stromal sarcoma (cancer that begins in connective tissue cells). There were an estimated 43,470 new cases diagnosed and 7,950 deaths from endometrial (uterine corpus) cancer in the United States in 2010.
Ovarian Cancer: Cancer that forms in tissues of the ovary (one of a pair of female reproductive glands in which the ova, or eggs, are formed). Most ovarian cancers are either ovarian epithelial carcinomas (cancer that begins in the cells on the surface of the ovary) or malignant germ cell tumors (cancer that begins in egg cells). There were an estimated 21,880 new cases diagnosed and 13,850 deaths from ovarian cancer in the United States in 2010.
The OVDx™ Test and Ovarian Cancer
Frequently undiagnosed, women’s ovarian cancer often goes undetected in its early stages allowing the cancer to spread un-check and subsequently results in a high mortality rate.
According to the American Cancer Society in 2010, in the United States:
- About 21,880 women received a new diagnosis of ovarian cancer, and
- About 13,850 women died from ovarian cancer
Ovarian cancer is the ninth most common cancer among women, excluding non-melanoma skin cancers. It ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Ovarian cancer accounts for about 3% of all cancers in women. A woman's risk of getting ovarian cancer during her lifetime is about 1 in 71, and her lifetime chance of dying from ovarian cancer is about 1 in 95 (These statistics don’t count low malignant potential ovarian tumors.)
The rate at which women are diagnosed with ovarian cancer has been slowly falling over the past 20 years. If ovarian cancer is found (and treated) before the cancer has spread outside the ovary, the 5-year survival rate is extremely good - 93%. However, less than 20% of all ovarian cancers are found at this early stage.
To aid in the early detection of ovarian cancer, Provista is developing a simple blood test called OVDx™. Initial studies have proven extremely promising; an overall accuracy demonstrated of 96% with both high sensitivity and specificity.
With the goal of narrowing the timeframe between cancer incidence and cancer detection, it is Provista's goal to have the OVDx™ Test serve as a new and very powerful analytical tool for physicians to employ in their fight to detect ovarian cancer earlier and subsequently dramatically improve present healthcare outcomes associated with this disease.
Provista anticipates clinical trials to be completed by late 2012.
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