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Diagnostics - Ovarian Cancer Forum

Arrayit Corporation is at the forefront of ovarian cancer prevention by providing a comprehensive preventative program that includes an informational outreach to the public. This forum is intended to inform the public about the challenges of the disease, risk factors, symptoms, and the importance of early detection. If you have any additional questions about ovarian cancer, we encourage you to visit your healthcare professional. Regular physical check-ups with your doctor are recommended for all women.

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What is ovarian cancer?
Ovarian cancer is a medical condition resulting from the abnormal growth of cells comprising the ovaries. Similar to other types of cancer, ovarian cancer cells can spread from the ovaries to other parts of the body, causing further medical complications.

What are ovaries and where are they located?
Ovaries are small, oval-shaped organs in women that produce and store eggs and secrete the female hormones estrogen and progesterone. Women have two ovaries, one located on the left side of the pelvis and the other located on the right side of the pelvis. Each ovary measures approximately 1.0 x 2.5 cm in size, about the size of an almond. Figure 1 illustrates the location of the ovaries in the pelvic region.

Figure 1. 
Illustration of the female pelvic region and the two ovaries, as well as the other components of the reproductive system.

Are there different types of ovarian cancer?
Yes. About 90% of ovarian cancers arise from the cells that comprise the surface or epithelium of the ovaries, and about 10% arise from other types of ovarian cells including the egg cells and supporting cells.

How common is ovarian cancer?
According to the Centers for Disease Control (CDC), the lifetime risk of ovarian cancer among American women is approximately 1.6%, which means that nearly 1 in 60 women will be diagnosed with the disease at some point in their lives. Ovarian cancer is the fifth leading cause of cancer death among American women and the leading cause of reproductive cancer death. Historically, only 35% of women with this disease have gone on to become long-term survivors.

Does family history increase the risk of ovarian cancer?
Yes. According to the CDC, the lifetime risk of ovarian cancer among American women rises from 1.6% to approximately 5% or 1 in 20 in women who have first-degree relatives affected by the illness. However, ovarian cancer occurs more often in women without a family history of the illness than in women with a family history. The disease is also prevalent in women who are carriers for certain gene mutations.

What is a gene mutation?
A gene mutation is a mistake in the genetic code that results in the improper function of a gene in the human body. Mutations can be inherited from our parents or caused by environmental factors such as viral infections or exposure to harmful chemicals.

Do specific gene mutations increase the risk of ovarian cancer?
Yes. According to the CDC, the lifetime risk of ovarian cancer among American women rises from 1.6% to as high as 25-60% for women bearing specific mutations in genes known as BRCA1 and BRCA2. BRCA1 and BRCA2 genes are known as tumor suppressor genes because they function in the body to prevent the formation of tumors. Mutations in BRCA1 and BRCA2 impair the normal function of the genes, allowing the growth of tumors such as those found in ovarian cancer.

Do other genetic factors increase ovarian cancer risk?
Yes. According to Johns Hopkins University and the Mayo Clinic, a family history of hereditary nonpolyposis colorectal cancer (HNPCC) and a past history of breast cancer increase the risk of ovarian cancer.

Can physiological factors impact the risk of ovarian cancer?
Yes. According to Johns Hopkins University and the Mayo Clinic, the risk of ovarian cancer increases slightly among women who have taken certain types of hormone replacement therapy. The lifetime risk of ovarian cancer is also slightly higher among woman who have never taken the birth control pill and among women who have never been pregnant.

Does ovarian cancer risk vary among ethnic groups?
Yes. According to Johns Hopkins University and the Mayo Clinic, the risk of ovarian cancer is slightly higher among women of European and Jewish descent compared to women of other ethnic groups.

What are the mortality rates associated with ovarian cancer?
According to the American Cancer Society, ovarian cancer is responsible for the deaths each year of approximately 21,000 women in the United States and approximately 140,000 women worldwide. Ovarian cancer is a serious illness.

What are the most common presenting symptoms of ovarian cancer?
According to the Mayo Clinic, unusual abdominal pressure, fullness, swelling or bloating, pelvic discomfort or pain, discomfort or pain during intercourse, persistent indigestion, gas or nausea, changes in bowel habits such as constipation, changes in bladder habits including frequent urination, loss of appetite or quickly feeling full, increased abdominal girth, clothes fitting tighter around the waist, a persistent lack of energy, and lower back pain are all symptoms of ovarian cancer.

Why is ovarian cancer known as the “silent killer”?
Ovarian cancer is known as the "silent killer" because the normal physical changes that occur during the monthly menstrual cycle are similar to many of the symptoms of ovarian cancer, particularly at the earliest stages of the disease. For this reason, many women ignore the symptoms of ovarian cancer for years after feeling the initial symptoms. Most women (~70-75%) are diagnosed at later stages of the illness.

Why is early stage detection of ovarian cancer so important?
Early stage detection of the disease is critical because it greatly improves the prognosis of the illness and the treatment options. According to the American Cancer Society, women diagnosed and treated at the earliest stages of the illness (stage IA and IB) have a 93% 5-year survivability, compared to a 5-year survivability of just 18% for women diagnosed and treated at the latest stage (stage IV).

Can ovarian cancer be cured by early stage detection and treatment?
Yes. According to Dr. Julie A. Taguchi, MD, of the Sansum Medical Clinic in Santa Barbara, CA, surgical removal of stage IA ovarian tumors effectively cures ovarian cancer in a large percentage of patients without the requirement for chemotherapy. According to the medical literature, the 20-year survival rate for stage IA patients is very good.

Can early stage detection of ovarian cancer preserve fertility?
Yes. According to the Fertile Hope Gynecologic Center, some stage IA ovarian cancer patients are eligible for fertility sparing surgery, which removes the affected ovary and leaves the unaffected ovary intact. In many cases, women with a single ovary are capable of having a successful pregnancy.

What is CA-125?
Cancer antigen 125 (CA-125) is a normal cellular protein expressed in the cells of all women. Certain physiological conditions including ovarian cancer can cause elevated levels of CA-125, which can be detected in the bloodstream.

What is a CA-125 test?
The CA-125 test measures the abundance of the CA-125 protein in a woman’s bloodstream. Whole blood is drawn with a needle and CA-125 levels are measured using a detection reagent known as a monoclonal antibody. The normal range of CA-125 is 0-35 units per ml of whole blood, and levels above 35 U/ml are considered abnormal. High levels of CA-125 can correlate with ovarian cancer, but elevated CA-125 is also seen in some healthy women, during the first trimester of pregnancy, and in the cases of ovarian cysts and pancreatitis.

What is transvaginal ultrasound?
Transvaginal ultrasound is an outpatient procedure used to visualize a woman’s pelvic region including the ovaries. An ultrasound probe generates sound waves that reflect off solid structures in the body. The reflected sound waves are compiled into an image of the pelvic region using a computer, and the image is displayed on a video screen in real-time. Health care professionals use ultrasound images to detect abnormal structures in the pelvic region including ovarian tumors.

Are CA-125 and transvaginal ultrasound sufficient for early stage ovarian cancer screening?
No. According to a recent by the Stanford University School of Medicine and the Canary Foundation, current testing procedures including CA-125 and transvaginal ultrasound are insufficient for use as routine screening tests for early stage ovarian cancer.

What is the Arrayit OvaDx® Pre-Symptomatic Ovarian Cancer Test?
Arrayit Corporation has pioneered a new ovarian cancer screening test known as OvaDx®, which stands for ovarian cancer diagnosis. Based on the latest advances in life sciences technology, OvaDx® uses a sophisticated detection device known as a microarray to detect ovarian cancer as early as 5 years in advance of any overt disease symptoms. OvaDx® has been shown in research studies to detect stage IA tumors with high sensitivity and specificity.

What does OvaDx® detect?
OvaDx® detects a woman’s immune response, which is activated as soon as ovarian cancer cells begin to grow. The immune system identifies ovarian cancer cells as an abnormal condition in the body, and quickly activates an immune response to combat the illness. By measuring the immune response, OvaDx® is able to detect ovarian cancer at its earliest stages and much earlier than current tests.

How is the OvaDx® testing procedure performed?
OvaDx® is an advanced and non-invasive molecular diagnostics testing procedure. A few drops of blood are drawn and spun at high speed to collect the serum. A small amount of serum is then applied to an OvaDx® microarray to allow binding reactions to occur between the patient's serum molecules and capture agents on the OvaDx® testing substrate. Following the binding step, the test is stained with fluorescent molecules to visualize the captured molecules and a report is generated based on a scanned digital image. Samples that produce positive signals on OvaDx® are scored as positive for ovarian cancer whereas samples that fail to produce positive signals are scored as negative.

When will OvaDx® be available?
OvaDx® is currently to be used for research purposes only. OvaDx® as a clinical diagnostic test will be available to the public upon FDA approval.


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