Question 1

What is the Certitude Test?

Accepted Answer

Certitude® is a simple, accurate blood test designed to detect breast cancer in women with dense breast tissue or are at high risk for breast cancer.

Question 2

How does it work?

Accepted Answer

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

Question 3

When will it be available?

Accepted Answer

It is available to order now. Visit the Get Started page to begin ordering the Certitude test.

Question 4

Which patients benefit most from a Breast Cancer Blood Test?

Accepted Answer

The Certitude test is intended for use in women with dense breasts (BI-RADS C/D) aged 40 years and older at average or high risk for breast cancer as a supplement to mammogram.

The test has not been evaluated in individuals with a personal history of cancer (except non-melanoma skin cancer), autoimmune disorders, or during pregnancy.

Question 5

Where does Certitude fit in the breast cancer screening pathway?

Accepted Answer

Certitude is a blood-based test designed to provide an additional layer of information within established breast cancer screening pathways. Mammography remains the foundation of routine breast cancer screening along with supplemental or diagnostic testing when clinically appropriate.

Certitude may be considered after mammography when additional biological insight could help inform next steps. Certitude results should be considered alongside imaging findings, breast density, individual risk factors, clinical history, and physician judgment. If a Certitude result is abnormal, appropriate follow-up imaging and further diagnostic evaluation are recommended based on the patient’s clinical context.

Question 6

How does Certitude support dense breast screening?

Accepted Answer

Dense breast tissue can make mammographic interpretation more challenging because both fibroglandular tissue and many breast cancers appear white on mammography. Breast density is also an independent breast cancer risk factor, making individualized screening decisions particularly important for women with BI-RADS C or D density.

The published validation study of Astrin Biosciences’ deep-proteomic classifier reported 92.6% sensitivity in its held-out validation cohort, with a modeled negative predictive value of >99% illustrating the test’s potential as a supplemental screening option, particularly for patients with dense breasts.

Question 7

How does Certitude use deep plasma proteomics?

Accepted Answer

Certitude analyzes patterns of proteins circulating in plasma rather than relying on a single tumor marker or circulating tumor DNA (ctDNA). Proteins reflect active biological processes, including cell signaling, immune response, metabolism, and tissue remodeling, providing information about disease biology even when a tumor is small.

Astrin Biosciences uses high-throughput mass spectrometry to perform deep profiling of the plasma proteome. In the published clinical validation study, over 9,000 unique proteins were represented, with a median of more than 7,000 per sample. A machine-learning classifier then analyzes the resulting multidimensional protein pattern to distinguish patterns uniquely associated with breast cancer.

This approach is designed to identify a biological signature across many proteins rather than depend on any single biomarker.

Question 8

Which BI-RADS categories may be appropriate for Certitude?

Accepted Answer

Certitude may be considered in several clinical scenarios in which additional information could support breast-care decision-making, including:

Women age 40 or older with dense breasts—BI-RADS breast density category C or D—and a negative mammogram.
Patients with inconclusive or indeterminate mammographic findings, including BI-RADS assessment categories 0 or 3.
High-risk women with a negative or equivocal mammogram when Certitude is being considered as part of a broader high-risk screening strategy.
Patients with suspicious findings, including selected BI-RADS 3 or 4 assessments, when the result may provide an additional clinical data point.

A patient’s Certitude result should not be considered in isolation. It is intended to be interpreted alongside imaging findings, breast density, clinical history, overall breast cancer risk, and physician judgment. Suspicious imaging findings should continue to be managed according to appropriate diagnostic pathways.

Question 9

How should sensitivity, specificity and NPV be interpreted?

Accepted Answer

These measures answer different clinical questions.

Sensitivity describes how often a test correctly identifies patients who have breast cancer. In Astrin Biosciences’ published held-out validation cohort, the classifier demonstrated 92.6% sensitivity, meaning approximately 93 of every 100 cancers in that study population were correctly classified as positive.

Specificity describes how often a test correctly identifies patients who do not have breast cancer. The same validation cohort demonstrated 92.3% specificity.

Negative predictive value, or NPV, describes the probability that a patient with a negative test result does not have the disease. The published study reported a modeled NPV of >99%. Because predictive values change with disease prevalence, NPV should always be interpreted in the context of the population being tested and the patient’s underlying risk.

Question 10

Is there guidance for when physicians should offer a breast cancer blood test?

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 11

How can I order a test?

Accepted Answer

Visit the Get Started page to begin ordering the Certitude test.

Question 12

What preparations are necessary for the blood test?

Accepted Answer

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

Question 13

Is Certitude FDA approved?

Accepted Answer

The Certitude test is not FDA approved. The Certitude test is available for clinical use through Astrin Biosciences's CLIA-certified and CAP-accredited laboratory and is intended for clinical use consistent with applicable CLIA regulations.

Question 14

Is Certitude covered by insurance?

Accepted Answer

Certitude is not currently covered by insurance; however, Astrin Biosciences is actively working with different insurance providers to cover this test.

Question 15

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

Accepted Answer

When you 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 16

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 17

What happens if the result indicates Abnormal Protein Pattern Detected?

Accepted Answer

This result does not necessarily mean cancer. It signals the need for further evaluation. Additional imaging and workup is as per guidance of the treating provider and can include (but is not limited to), mammogram, ultrasound, or breast MRI.

Question 18

How can I get Certitude in my practice?

Accepted Answer

Visit the Get Started page to begin ordering the Certitude test.

Question 19

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

Accepted Answer

Certitude is designed for breast cancer detection and is not intended as a molecular residual disease, recurrence-monitoring, or treatment-response test.

Tests used for molecular residual disease, or MRD, answer a different clinical question: whether evidence of a previously diagnosed cancer remains or reappears after treatment. These assays commonly track tumor-specific genomic alterations or other biomarkers over time in patients with a known malignancy.

Certitude instead evaluates a proteomic signature associated with breast cancer to provide additional information during the screening and detection pathway.

Question 20

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

Accepted Answer

Use the Get Started form to receive updates.

Question 21

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