Question 1

What is the Certitude Blood Test?

Accepted Answer

The Certitude&trade; Blood Test detects 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

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 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 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

Women with dense breasts who are eligible for a mammogram 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 had or are undergoing cancer treatment, have autoimmune disease, or are pregnant.

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 Blood 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, Certitude Blood 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 Blood 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 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 treatment options may be more effective. 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 choose what is most convenient either completing your blood draw at participating doctor's offices or by scheduling a visit to a partner lab.

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.

Question 16

What does it mean if it indicates more testing is needed?

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 it indicates no testing is needed?

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

Why are additional diagnostic tests needed with an Additional Testing Indicated result?

Accepted Answer

An Additional Testing Indicated 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 diagnostic 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 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