EarlyCDT^® Frequently Asked Questions section

This page contains answers to commonly-asked questions about EarlyCDT^® platform.
Please do not forget to check EarlyCDT^®-Lung FAQ section and EarlyCDT^®-Breast FAQ section.

How EarlyCDT^® works?

Cancerous tumors produce protein molecules known as —“markers”. These proteins are also called “antigens.”

This is how EarlyCDT^® works:

• Antigens are certain by–products from cancer cells that are produced very early in a tumor's development, and they trigger the body's immune system to respond.
• The immune system releases autoantibodies to fend off these antigens.
• The immune system produces many more autoantibodies than the tumor does antigens, making the autoantibodies easier to detect than the antigens.
• The immune system does not normally produce antibodies against normal tissue proteins; therefore, these autoantibodies to cancerous tissue antigens provide high specificity.
• EarlyCDT^®  measures autoantibodies produced in response to a number of antigens associated with a particular type of tumor.
• The measurement of autoantibodies provides an early indication that a tumor exists, thus improving the potential for saving a life.

Is one antigen on the test panel more relevant to disease diagnosis than another?

At this time, all of the antigens are equally relevant, therefore the overall result is positive if one or more of the autoantibodies to a specific antigen are present at a level above the cut-off value.

What do sensitivity, specificity and reproducibility mean?

The sensitivity of a test such as EarlyCDT® depends on its ability to identify its target, in EarlyCDT®’s case, autoantibodies to a cancer–associated protein, even at very low levels. 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).

What are the sample requirements for EarlyCDT®?

The test requires a blood draw of 10 ml. There are no special requirements such as fasting necessary prior to your blood draw. The healthcare professional performing the draw will then use a centrifuge to spin down the blood sample and submit at least 5 ml (about one teaspoon) of serum to Oncimmune for testing.

What is the difference between EarlyCDT® and genetic testing?

Genetic testing can determine whether you carry a genetic mutation that indicates a predisposition to developing 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; additional tests are needed to confirm whether cancer is present. EarlyCDT® is designed to aid in the early detection of cancer at the moment of test but does not measure your likelihood of developing cancer in the future.

How are the results reported?

The test is reported to your doctor as either a negative or positive result via secure communication means. Your doctor will present and explain the results directly to you. The report may come back invalid which means we were unable to determine the result for one of autoantibodies. The test report will include the results for all of the measured autoantibodies.

What does a negative EarlyCDT® result mean?

A negative EarlyCDT® result means that the test did not detect antibodies that are associated with a specific tumour. It does not indicate you do not have cancer, nor does it alter your risk. You should still be evaluated carefully and monitored regularly by your healthcare provider, if you are at high risk for cancer.

Does a positive result mean that I have cancer?

A positive EarlyCDT® result indicates that autoantibodies to one or more of the cancer antigens in the EarlyCDT® panel exist in quantities exceeding a cut-off value. This suggests that a tumour may be present. Your doctor can combine this information with the result of other tests as an aid in evaluating whether cancer is present.

What do I do if my test result is negative?

If your result is negative, your health-care provider will probably recommend that you continue your regular schedule of testing and examination. A negative test does not mean that you do not have cancer, remember that you still might be in high risk group.

How will I get my results?

Your results will be made available to your doctor/health-care provider and you will need to talk with your doctor to review those results.

What forms of payment are accepted?

Credit Cards:

• VISA
• MasterCard

Cheques:

• Personal cheque
• Cashier’s cheque
• Money order

Cash will not be accepted

How do I pay for the test if not through the website?

When a patient has his or her blood drawn for the test, they will need to fill out the payment portion of the Test Requisition Form (TRF), tear or cut off the payment portion and provide to the laboratory for payment verification. Once the laboratory has verified the payment and collected the tender (if applicable), insert both the tender and tear off from the TRF in the payment envelope provided in the collection kit. The payment will need to accompany the sample in the collection kit and be sent to Oncimmune®'s laboratory facility for testing.

Is the EarlyCDT® procedure covered by insurance?

At this time, insurance carriers do not cover EarlyCDT®; however, we advise you to contact your insurance company to discuss whether the opportunity for assistance exists.