Question 1

What is the Certitude Test for Breast Cancer?

Accepted Answer

The Certitude™ Test detects breast cancer associated proteins from blood. False positive and false negative results do occur. The Certitude Test should be used in addition to healthcare provider's recommended screening tests.

Question 2

Can a Blood Test for Breast Cancer Replace a Mammogram?

Accepted Answer

No, the Certitude Test is a supplemental test to mammogram screening. It is not meant to replace routine screening.

Question 3

Is the test approved by the FDA?

Accepted Answer

Many blood tests are not individually approved by the FDA. Instead, they are performed in CLIA-certified and CAP-accredited laboratories, which are regulated to ensure tests are accurate, reliable, and safe for patient care. Certitude falls into this category, meaning the test is validated and performed in a highly regulated laboratory environment that meets strict quality standards.

Question 4

How can I order the Certitude Test?

Accepted Answer

The test is available by prescription only. You can request a test through your healthcare provider or by requesting Certitude through the telemedicine provider, OpenLoop Health.

Question 5

How Does a Breast Cancer Blood Test Detect Cancer?

Accepted Answer

When cancer cells form, they release proteins into the the bloodstream. Historically, finding these specific proteins has been difficult due to the abundance of other proteins. The Certitude Test filters out normal proteins and uses AI to identify abnormal ones detecting signals of cancer at its earliest stages. False positive and false negative results do occur.

Question 6

Who Should Get a Breast Cancer Blood Test?

Accepted Answer

Women with dense breasts who have had a mammogram or those referred by their provider can take the test. The Certitude Test is especially valuable for women with dense breasts whose cancers may not appear on traditional imaging.

Question 7

How accurate is the test?

Accepted Answer

Across studies the test has maintained around 90% overall sensitivity. When accounting for prevalence, the Certitude Test has a negative predictive value (NPV) above 99%, making it reliable to rule out breast cancer. False positive and false negative results do occur.

Question 8

What does sensitivity mean?

Accepted Answer

Sensitivity, or the true positive rate, is the ability of a test to detect those who truly have the condition. A true positive refers to those who have the condition and who have tested positive for the condition. For example, if there are 10 people with breast cancer, the Certitude Test will detect 9 of them.

Question 9

What does Negative Predictive Value (NPV) mean?

Accepted Answer

Negative predictive value (NPV) defines how likely it is that when someone receives a negative result, they do not have breast cancer. The Certitude Test has a NPV of  >99% meaning that of 100 women who receive a negative result, less than 1 of them will have undetected cancer.

Question 10

How often should I take the Certitude Test?

Accepted Answer

The Certitude Test can be taken as an annual blood test. Adding the Certitude Test to yearly wellness visits can improve your chance of finding a breast cancer signal early, when treatment options may be more effective. The Certitude Test identifies cancer proteins currently in the bloodstream and does not predict future risk for cancer.

Question 11

Does health insurance cover the test?

Accepted Answer

Certitude is not currently covered by insurance; however, we are actively working with different insurance providers to add this test. You may be able to use pretax dollars in your flexible spending account (FSA) or health savings account (HSA) to pay for the Certitude Test. Check with your FSA or HSA administrator to confirm eligibility.

Question 12

How do I complete my blood draw?

Accepted Answer

When you're ready to take the Certitude test, you can choose what is most convenient for you: visit a partner lab or, where available, schedule a mobile blood draw at your home or work.

Question 13

Do I need to fast before the blood draw?

Accepted Answer

No fasting is required for the Certitude Test.

Question 14

How much blood is drawn for the Certitude Test?

Accepted Answer

Approximately 2 teaspoons (or about 10 mL) of blood is drawn from a vein in your arm.

Question 15

When will the Certitude Test results be available?

Accepted Answer

Typically, you can expect to receive your test result about 2 weeks after your sample arrives at the Astrin Biosciences lab. In certain cases, results may take up to 4 weeks.

Question 16

What does it mean if the result is Abnormal Protein Pattern Detected?

Accepted Answer

This result does not mean that cancer has been detected. It indicates that follow-up evaluation may be appropriate. Your healthcare provider will determine the most appropriate next steps, which may include imaging such as mammography, ultrasound, or breast MRI.

Question 17

What does it mean if the result is No Abnormal Protein Pattern Detected?

Accepted Answer

This result indicates a low likelihood of breast cancer at the time of screening, and no additional testing is indicated based on this result. You should continue routine screening according to your healthcare provider's recommendations.

Question 18

What does it mean if the result is Equivocal Protein Pattern Detected?

Accepted Answer

This result does not mean that you have cancer. This result needs to be looked at along with other information about your health. Your healthcare provider will guide the next steps, which could be continuing routine screening or recommending additional testing.

Question 19

Why is additional testing needed with an Abnormal Protein Pattern Detected result?

Accepted Answer

An Abnormal Protein Pattern Detected result does not mean that cancer has been detected. It means the test identified a signal that may benefit from further evaluation to gather more information.

Additional tests help your healthcare provider better understand what may be causing the signal and determine whether anything further needs attention. Your provider will recommend the most appropriate next steps based on your individual situation. This may include imaging tests such as a mammogram, ultrasound, or breast MRI.

In many cases, follow-up testing helps confirm that no cancer is present, but it is an important step to ensure a complete evaluation.

Question 20

Can you share my test result with one of my healthcare providers?

Accepted Answer

All results are automatically shared with the provider who ordered the test. If you would like us to fax your result to an additional healthcare provider, go to the Certitude order portal.

Question 21

Where is the test available?

Accepted Answer

Certitude is actively being rolled out across the US. Find out if it is available in your area by requesting Certitude.

Question 22

Can Certitude be used to monitor treatment effectiveness or recurrence after breast cancer treatment?

Accepted Answer

No, Certitude has not been tested on patients that are undergoing or have undergone treatment for cancer.

Frequently Asked Questions

Frequently Asked Questions