Frequently Asked Questions About Breast Cancer

^{Expected to be available in 2010}

Breast cancer can be a risk for every woman and may cause anxiety and fear. Especially for women at increased risk for breast cancer, every screening can be a difficult experience. However, the more knowledge we have the better equipped we are to deal with whatever comes along. Likewise, the earlier a cancer is diagnosed the better the outlook.

Here are answers to some frequently asked questions about the EarlyCDT^™-Breast. They will help you understand your physician's decision should he or she recommend the test for you.

Why should I be examined for breast cancer with both EarlyCDT^™-Breast and mammography?
EarlyCDT^™-Breast is designed to be used in conjunction with other testing to be most effective. Using mammography by itself only reduces breast cancer fatality by 23%.¹ EarlyCDT^™-Breast is recommended annually with your mammogram to increase the likelihood of early cancer detection.

¹ Chapman, C., et al. “Autoantibodies in Breast Cancer: Their Use as an Aid to Early Diagnosis.” Annals of Oncology. 18:868-873, March 2007 (online publication).

Who should be screened for breast cancer using the EarlyCDT^™-Breast as well as mammography?
Women of any age might benefit from a combination of EarlyCDT^™-Breast and mammography. However, it is most often recommended for women aged 55 or under who have one or more of the risk factors for breast cancer (visit www.oncimmune.com, www.cancer.gov or www.cancer.org and speak to your physician for more information about risk factors).

• Beginning your menstrual cycle before the age of 12
• Having a close relative with breast or ovarian cancer (first tier/second tier)
• Dense breast tissue
• Taking hormone replacement therapy (HRT), estrogen, progesterone, thyroid hormone or cortisone consistently for more than a year
• Having had a breast biopsy or a breast biopsy result of atypical hyperplasia
• Not having children or having your first child after age 30
• Drinking one or more alcoholic beverages a day.

If you would like to know more about breast cancer risks, please visit the National Cancer Institute's website at www.cancer.gov or the American Cancer Society site at www.cancer.org.
If you have concerns, please talk to your healthcare provider.

What is the difference between EarlyCDT^™-Breast and genetic testing?
Genetic testing can determine whether you carry a genetic mutation that indicates a predisposition to developing breast cancer. It helps you better understand the likelihood of developing cancer at some point in the future. A positive EarlyCDT^™ indicates that cancer might already be present in the body. It is a test designed to aid in early detection of cancer now rather than a way to measure your likelihood of developing cancer in the future.

What is HRT and how is it related to breast cancer?
HRT stands for Hormonal Replacement Therapy and is most commonly used to treat menopausal symptoms. When cells become cancerous, exposure to estrogen increases the cancer's growth and could affect the results of the test.

Who benefits from the Oncimmune^® EarlyCDT^™ -Breast?
Women answering “yes” to one or more of the questions in the breast cancer risk models, such as the Gail Model, should talk to their physician about their risk of developing breast cancer. The models can be found on the National Cancer Institute's website at:
www.cancer.gov or American Cancer Society at www.cancer.org.

Does a negative result mean I don't have to be concerned about breast cancer?
A negative EarlyCDT^™-Breast does not mean you do not have breast cancer, just as mammography is not a foolproof screening method. However, if both mammography and the EarlyCDT^™ are negative, it increases the likelihood that you do not have the disease. Early clinical tests indicate that more than 99 percent of women with a negative mammogram and a negative EarlyCDT<^™ will not have breast cancer at the time of testing.²

You should continue the regular schedule of cancer screenings advised by your physician.

² The value 99.5 percent is the negative predictive value of EarlyCDT^™-Breast in combination with mammography. It reflects the number of patients who test negative based on a formula that takes into account true negatives and false negatives.

What are the implications of a positive test?
In the event of a positive EarlyCDT^™-Breast result– when one or more of the autoantibodies used in the testing procedure is elevated beyond a certain level– your physician might recommend more tests, such as ultrasound or magnetic resonance imaging (MRI). If these additional imaging tests do not detect a breast cancer, your physician might recommend more frequent examinations, imaging and testing.

What does a negative EarlyCDT^™-Breast result mean?
A negative test result indicates that the autoantibody levels for each antigen in the multi-antigen panel were below the cut-off value. Since the formation of cancerous tumors cannot be predicted, EarlyCDT^™-Breast is recommended annually. If you have other questions regarding your test results, please follow up with your healthcare provider.

What is the recommended follow-up for a positive EarlyCDT^™-Breast?
Your healthcare provider knows your medical history, and it is recommended that you follow up with your healthcare provider for the next steps associated with a positive test. You could also reference the protocol described later in this FAQ in answer to the question What happens if my EarlyCDT^™-Breast is positive?.

What is the Gail Model?
The Gail Model is one of several established methods for estimating your five-year and lifetime risk of developing breast cancer. The model assigns you a number, called the Gail model score, based on these risk factors:

• Chronological age and race
• Age of first menstruation
• Age at first live birth
• Number of first-degree relatives (mother, sister, daughter) who develops breast cancer
• Number of breast biopsies or a breast biopsy result of atypical hyperplasia

How are the questions on the requisition form relevant to EarlyCDT^™-Breast?
The questions on the requisition form are designed to provide a snapshot of the patient history as needed when completing a risk assessment, such as the Gail Model. Oncimmune^® believes the clinical data obtained will aid the oncology staff with direction when dealing with a positive result.

The requisition form asks for “oral contraceptives;” however, there are other forms of contraceptives with estrogen/progestogen that could be considered. Should I select the box anyway?
Yes. Women taking any form of estrogen/progestogen contraceptive should select the “oral contraceptive” box. The term is used because it is the most widely recognized form of hormonal birth control. Other forms that could be considered are NuvaRing^®, Depo-Provera, and Norplant.

What happens if my EarlyCDT^™-Breast is positive?
The chart to the right outlines the recommended follow-up to test results.

Your physician will work with you to determine the best approach for you but the chart below outlines the typical follow–up to test results.

The typical protocol begins with a review of your mammogram and physical examination. The chart shows you what might follow if the mammogram and physical exam are negative and your EarlyCDT^™-Breast results are either positive or negative. Ultrasound and magnetic resonance imaging (MRI) are tests that supplement mammography to obtain as thorough a picture of the breast as possible.

What does it mean when I'm told my EarlyCDT^™-Breast has high sensitivity, specificity and reproducibility? The effectiveness of a diagnostic test such as EarlyCDT^™-Breast depends on its ability to identify its target—in EarlyCDT^™-Breast's case, an autoantibody to a cancer–associated protein, or antigen—even at very low levels (sensitivity). The test must also be able to identify autoantibodies specific to the cancer–associated proteins (specificity). Finally, the test must produce the same results over and over under the same set of circumstances (reproducibility). Early clinical tests indicate that EarlyCDT^™-Breast may be highly reproducible with high sensitivity and specificity, making it a reliable diagnostic tool.

What is the EarlyCDT^™-Breast procedure like?
EarlyCDT^™-Breast requires only a blood sample that can be taken at your ordering physician's office. The sample is sent to Oncimmune^®'s CLIA–compliant laboratory for analysis. Your ordering physician will receive the results of your EarlyCDT^™-Breast in about a week. You should arrange for your ordering physician to discuss the results with you.

Will the fact that I've taken the EarlyCDT^™-Breast be reported to my health insurance provider? At this time, the Oncimmune^® EarlyCDT^™-Breast is not covered by health insurance, although patients can talk to their insurance company and attempt to seek coverage. Patients pay for the procedure out of pocket. Therefore, the physician is not required to give any information regarding the EarlyCDT^™-Breast to an insurance company unless you request a claim be submitted to the insurance company or otherwise authorize such disclosure. You may request that your physician maintain the confidentiality of your test results, unless you authorize such disclosure.