Frequently Asked Questions From Providers About EarlyCDT^™-Breast

^{Expected to be available in 2010}

What does a negative EarlyCDT^™ result mean?
A negative test result indicates the multi-test autoantibody panel measured below the cutoff value. Since formation of cancer tumors cannot be predicted, EarlyCDT^™ is recommended annually with a mammogram.

What if the autoantibodies are close to the cutoff value of the test? Does this mean the patient is close to a positive result for the Oncimmune^® EarlyCDT^™?
No. The test has a specific cutoff value, and autoantibodies close to the cutoff do not indicate that the patient is near a positive result. The positive indicator for the EarlyCDT^™ is one or more autoantibody over the cutoff value.

What is the difference between EarlyCDT^™ and genetic testing?
Genetic testing can determine whether your patient carries a genetic mutation that indicates a predisposition to developing cancer. A positive EarlyCDT^™ indicates that cancer might already be present in the body. EarlyCDT^™ is designed to aid in the early detection of cancer at this moment rather than a way to measure the likelihood of developing cancer in the future.

Does a negative result mean the patient does not have to be concerned about breast cancer?
A negative EarlyCDT^™ does not mean breast cancer is not present, just as mammography is not a foolproof screening method. More than 99% of women with a negative mammogram and a negative EarlyCDT^™ will not have breast cancer at the time of the testing. The value 99% is the negative predictive value of EarlyCDT^™. It reflects the number of patients who test negative based on a formula that takes into account true negatives and false negatives.

What is the recommended follow-up for a positive EarlyCDT^™-Breast?
The recommended treatment/follow-up is described in the EarlyCDT^™ Patient Education Guide on page 8. If you do not have a Patient Guide, please click here to download.

To order additional Patient Education Guides for your office, please contact Client Services at 888-583-9030 to place your order.

Why should patients 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. Mammography can only determine the outcome at the time of the test. Using mammography by itself only reduces fatality by 23%.* EarlyCDT is recommended annually with a patient's mammogram to increase the likelihood of early detection.

*Source: 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 examined for breast cancer using both EarlyCDT^™-Breast and 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.

The requisition form asks for oral contraceptives; however, there are forms of contraceptives with estrogen/progestogen that could be considered. Should patients 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^®.

Do you take payment arrangements?
Currently, Oncimmune^® is set up to accept credit cards, checks or money orders. We are also considering alternate payment options such as bill me later for our clients.

Does EarlyCDT^™-Breast indicate the type of breast cancer present?
At this time, EarlyCDT^™ suggests only that breast cancer is present. It does not differentiate among types of breast cancer.

Does EarlyCDT^™-Breast indicate other types of cancer might be present?
EarlyCDT^™-Breast has been developed for use based on clinical histories that rule out other cancers.