Question 1

What is the Certitude Blood Test?

Accepted Answer

The Certitude&trade; Blood Test is a blood-based test to screen for breast cancer intended as a supplement to typical imaging.

Question 2

How does it work?

Accepted Answer

Cells release proteins into the plasma of the bloodstream. Historically, finding the cancer-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.

Question 3

When will it be available?

Accepted Answer

Astrin aims to launch Certitude in select markets in early 2026, followed by a nationwide rollout in the second half of 2026.

Question 4

Which patients would benefit from the Certitude Blood Test?

Accepted Answer

The Certitude Blood Test is intended for use in women aged 40 years and older at average to high risk for breast cancer and individuals at high risk below 40 years of age as a supplemental screening tool to mammogram.

The Certitude Blood Test is not a diagnostic test. A positive result indicates that further evaluation, such as diagnostic imaging or biopsy, may be warranted. A negative result does not rule out breast cancer. Regular screening according to clinical guidelines remains essential.

The test has not been evaluated in individuals with a personal history of cancer, other active cancers, autoimmune disorders, or during pregnancy. The test is not intended to replace mammography, MRI, ultrasound, or biopsy as recommended diagnostic tools.

Question 5

Is there guidance for when I should offer the blood test to my patients?

Accepted Answer

Adding annual testing with Certitude to recommended mammograms offers an increased opportunity for early cancer detection while avoiding unnecessary work up and biopsy in patients who are not likely to have cancer at that time

Question 6

How can I order a test?

Accepted Answer

Visit the Get Started page to begin ordering the Certitude Blood Test.

Question 7

What preparations are necessary for the blood test?

Accepted Answer

No specific preparations are necessary (i.e. fasting, etc.) to administer the Certitude Blood Test.

Question 8

Is Certitude FDA approved?

Accepted Answer

Certitude is not FDA approved. Certitude is available for clinical use through a CLIA-certified laboratory developed test (LDT) program.

Question 9

Is Certitude covered by insurance?

Accepted Answer

Certitude is not currently covered by insurance; however, the company is actively working with different insurance providers to add this test.

Question 10

Will I be informed of my patient's screening results?

Accepted Answer

When your prescribe the test, all results are automatically shared with you via the Certitude Physician Portal.

If a patient requests the test via a telehealth provider, they can add your email and fax number so that you also receive their results.

Question 11

How long does it take for test results to be available?

Accepted Answer

Typically, you can expect to receive the test result about 2 weeks after the sample arrives at the Astrin Biosciences Lab. In certain cases, results may take up to 4 weeks. The length of time to receive results does not indicate a potential result.

Question 12

What happens if the result is positive?

Accepted Answer

A positive test result is not a cancer diagnosis and requires follow-up diagnostic testing to confirm cancer. Additional imaging and workup is as per guidance of the treating provider and can include (but is not limited to), breast MRI and biopsy.

Question 13

How can I get Certitude in my practice?

Accepted Answer

Visit the Get Started page to begin ordering the Certitude Blood Test.

Question 14

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

Accepted Answer

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

Question 15

How can I stay up to date on the latest developments with Certitude?

Accepted Answer

Use the Get Started form to receive updates.

Question 16

Who should I contact if I have additional questions?

Accepted Answer

Use the Get Started form to reach out with additional questions or to request more information.

Frequently Asked Questions

Frequently Asked Questions