Certitude

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

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

Breast Cancer Screening
Why It Matters
Patient
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Patient

Who is this test for?

Certitude is for women who:

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

What is Certitude?

Peace of Mind From a Single Blood Draw

Certitude is a simple, accurate blood test designed to screen for breast cancer — especially in women with dense breasts or who are at high risk. It’s not a replacement for mammography, but a powerful new partner in your personal screening plan.

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

Learn More
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Backed by Clinical Data

Certitude’s performance shows strong sensitivity and specificity — regardless of breast density.

How does this compare with other screening options?

Compare published sensitivity and specificity across 3D mammography, ultrasound, CEM, MRI, and Certitude 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
  • 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.

  • 92% specificity

    This means the test correctly shows a negative result about 92 times out of 100 when a person does not have cancer. It’s very good at avoiding false alarms.

  • >99% NPV (Negative Predictive Value)

    This means that if your test result is negative, there is greater than a 99% chance you truly do not have cancer.

  • Works across breast density, breast cancer stages and subtypes

    These numbers hold true for non-dense and dense breast, early and late stages of cancer, and different breast cancer subtypes, meaning the test performs consistently no matter the type or stage of cancer.

Getting Certitude is Simple

From Requests to Results

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Certitude is available by prescription. Your healthcare provider can order it, or you can request it online through an independent telemedicine provider.

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What Providers Say

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"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."
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"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. Barbara Levy
Chief Medical Officer at Visana Health and Clinical Professor at George Washington University and UC San Diego Health

Understanding Your Results

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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.

Disclaimer: The Certitude Breast Cancer Screening Test and its performance characteristics were developed and validated by Astrin Biosciences, Inc., 1000 Westgate Dr., Suite 1009, Saint Paul, MN 55114. CLIA #24D2303035. CAP #: 24D2303035. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The Certitude test is performed in a CLIA-certified and CAP-accredited laboratory and is intended for clinical use consistent with applicable CLIA regulations.