Question 1

What is the Certitude Blood Test?

Accepted Answer

The Certitude&trade; Blood Test screens for breast cancer and can be taken annually as a simple blood draw. False positive and false negative results do occur. The Certitude Blood Test should be used in addition to healthcare provider's recommended screening tests.

Question 2

Does it replace a mammogram?

Accepted Answer

No, the Certitude Blood Test is a supplemental test to annual mammogram screening.

Question 3

Is the test approved by the FDA?

Accepted Answer

The Certitude Blood Test is not FDA approved. The Certitude Blood Test is available for clinical use as a CLIA-certified laboratory developed test (LDT).

Question 4

How can I order the Certitude Blood Test?

Accepted Answer

The test is available by prescription only. You can request a test through your healthcare provider or on our website through an independent telemedicine provider.

Question 5

How does Certitude look for cancer?

Accepted Answer

When cancer cells form, they release proteins into the plasma of the bloodstream. Historically, finding these specific proteins has been difficult due to the abundance of other proteins. The Certitude Blood 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 can take the test?

Accepted Answer

All women eligible for mammograms, those at high risk, or those referred by their provider can take the test. The Certitude Blood Test is especially valuable for women with dense breasts whose cancers may not appear on traditional imaging. Use of the Certitude Blood Test is not recommended in individuals who have gone or are undergoing active cancer treatment. The Certitude Blood Test should be used in addition to healthcare provider recommended screening tests.

Question 7

How accurate is the test?

Accepted Answer

In 1,214 women, Certitude Blood Test achieved 92% sensitivity and 92% specificity in detecting breast cancer with high sensitivity even at early stages. 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 100 people with breast cancer, Certitude Blood Test will detect 92% of them.

Question 9

What does specificity mean?

Accepted Answer

Specificity, or the true negative rate, is the ability of a test to detect those who are truly free of the condition. A true negative refers to those who do not have the condition and who have tested negative for the condition. For example, if there are 100 people without breast cancer, Certitude Blood Test will correctly identify 92% of them as not having breast cancer.

Question 10

How often should I take the Certitude Blood Test?

Accepted Answer

The Certitude Blood Test can be taken as an annual blood test. Adding the Certitude Blood Test to yearly wellness visits can improve your chance of finding a breast cancer signal early, when more treatment options may be available. The Certitude Blood 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 Blood Test. Check with 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 Blood Test, you can schedule your blood draw at a time and place convenient for you via the Certitude patient portal.

Question 13

Do I need to fast before the blood draw?

Accepted Answer

No fasting is required for the Certitude Blood Test.

Question 14

How much blood is drawn for the Certitude Blood Test?

Accepted Answer

Approximately 1 teaspoon (or about 4 mL) of blood is drawn from a vein in your arm.

Question 15

When will the Certitude Blood 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. In the event where the results will not be available within this time frame, the ordering physician and patient will receive an email notification (when an email was provided). It is important to understand that the timing of your test result does not indicate or predict the outcome of the test, nor does it impact the accuracy of the final result.

Question 16

What does it mean if I receive a Positive result?

Accepted Answer

A positive Certitude Blood Test indicates potential cancer associated proteins were detected. It does not necessarily mean cancer. It signals the need for further evaluation. You provider will recommend the appropriate follow-up, which may include imaging&mdash;like a breast MRI&mdash;or a biopsy if needed. False positive and false negative results do occur.

Question 17

What does it mean if I receive a Negative result?

Accepted Answer

A negative Certitude Blood Test indicates potential cancer associated proteins were NOT detected. This result does not completely rule out the possibility of cancer, and you should continue with other cancer screenings your provider recommends. False positive and false negative results do occur.

Question 18

Why are additional diagnostic tests needed with a Positive result?

Accepted Answer

A Cancer Signal Detected test result is not a cancer diagnosis and requires follow-up diagnostics testing to confirm cancer. Follow-up diagnostics may include imaging (i.e. confirmatory Breast MRI) and/ or biopsy ordered by your healthcare provider to confirm cancer.

Question 19

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 and complete the online form to add your healthcare provider.

Question 20

Where is the test available?

Accepted Answer

Certitude will be available in 2026 across the US. Join our mailing list to be notified when it's offered in your area.

Question 21

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