Certitude

With the Certitude Blood Test, you get Accuracy and Answers.

It’s finally here — a new way to detect breast cancer as early as Stage 0.

Have a Kit?
Breast Cancer Screening
Why It Matters
Patient
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Patient

Who is this test for?

Certitude is for women 40+ who:

  • Certitude LogoHave dense breast tissue or inconclusive mammogram results
  • Certitude LogoHave a family history or elevated risk of breast cancer
  • Certitude LogoNeed an additional layer of screening beyond mammography
  • Certitude LogoWant the peace of mind
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What is Certitude?

Peace of Mind From a Single Blood Draw

Certitude is a simple, accurate blood test designed to detect breast cancer in women with dense breast tissue.

Complements mammography for added confidence

Designed to screen for breast cancer as early as Stage 0 through protein biomarkers in your blood

Reduces anxiety for women who are high risk or those with dense breasts

How Certitude Works

Certitude analyzes specific protein patterns in your blood that are linked to breast cancer. Our advanced AI-driven technology detects these subtle changes—often before they can be seen on imaging.

Sample Processing

Blood Sample

Protein Isolation

Protein Analysis

Data Analysis

Protein Identification

Machine Learning

Cancer Proteins Detected

Backed by Clinical Data

Certitude’s performance remains strong across breast densities.

92%

Sensitivity

Drake (SABCS 2026)

90%

Sensitivity in Dense Breast

Horrmann (Endocrinology 2026)

91%

Sensitivity in High Risk Dense Breast

Advani (AACR 2026)

>93%

NPV

>99%

Negative Predictive Value (NPV)

92% Sensitivity: This means the test correctly finds cancer about 92 times out of 100 when cancer is truly present. In other words, it is very good at not missing cancers.

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.

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Patient

Current Screening Performance

How does this compare with other screening options?

Compare published sensitivity and specificity across 3D mammography, ultrasound, CEM, and MRI for women with dense breasts. These data do not come from a head-to-head study but provide a comparative side-to-side view.

Risk Graph
Learn More

Gilbert et al. (Lancet 2025)
Comstock et al. (JAMA 2020)
Pötsch et al. (Radiology 2020)

Getting Certitude is Simple

From Requests to Results

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Certitude is available by prescription. Your healthcare provider can order it. Coming soon — you can request it online through an independent telemedicine provider.

Download a Discussion Guide for Your Next Doctor’s Appointment
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What Patients Say

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Quote
I did everything right — yearly mammograms, ultrasounds, follow-ups — and still my cancer was missed. Knowing a blood test could find what imaging overlooked gives me hope for the future. I want other women to have every possible chance to catch cancer early.
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As someone with dense breasts, I have never felt like I had any clarity after my mammograms. Knowing that there is a test that could actually work for me gives me new found hope for me and all women who are at high risk for breast cancer.

What Providers Say

  • Quote
    Too many women with dense breasts are left without clear answers after their annual screening. Certitude offers something we’ve needed — a simple, accessible test that can help detect cancer earlier and provide greater clarity. Certitude represents a meaningful and long-awaited advancement — one that can help physicians intervene sooner, reduce anxiety, and guide more confident clinical decision-making.
    Dr. Barbara Levy
    Chief Medical Officer at Visana Health and Clinical Professor at George Washington University and UC San Diego Health
  • Quote
    Mammography remains our most powerful population-level screening tool, but it is not perfect — particularly for the many women with dense breasts. A blood-based test that can identify molecular signals of cancer before they’re visible on imaging has the potential to fundamentally reshape the breast cancer screening paradigm.
    Dr. Ben H. Park
    Prominent breast cancer physician-scientist

Understanding Your Results

Senior, caucasian, female doctor smiling while holding a clipboard

Straightforward Out-of-Pocket Pricing

Certitude is currently available as an out-of-pocket test option. Transparent pricing allows patients and providers to move forward without delays or uncertainty.

Certitude Test
$525$750Introductory Price

For a limited time, take advantage of the self-pay introductory rate for the Certitude test.

If the Certitude test is right for you, your provider will need to complete the test order form.

  • Includes kit, processing, and digital results

  • No hidden fees

  • Payment handled through the patient portal

A test request and blood draw must be completed between May 1, 2026 and Dec 31, 2026 to take advantage of this offer.*

*We anticipate the list price for the Certitude test will be $750 or more after the introductory period. The cost of the Certitude test may vary depending on the practice setting or healthcare provider who orders your test.

Get Started

Certitude will be available in 2026 across the US.

Join our mailing list to be notified when it’s offered in your area.

Frequently Asked Questions

Certitude

1000 Westgate Drive
St. Paul, MN 55114

© Astrin Biosciences 2025. All rights reserved.

The Certitude test was developed, and the performance characteristics validated by Astrin Biosciences Laboratories following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. This test has not been cleared or approved by the US Food and Drug Administration. The test is performed at Astrin Biosciences Laboratories. Astrin Biosciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing.