Improve Patient Confidence with a Breast Cancer Blood Test
High sensitivity.
Reduces anxiety for you and your patients.
>99% NPV
Rules out the need for unnecessary follow-up with high confidence
Women ≥40 with dense breasts (BI-RADS C or D) and a negative mammogram- Patients with inconclusive or indeterminate mammographic findings (e.g., BI-RADS 0 or 3)
- High-risk patients with a negative or equivocal mammogram, used as part of high-risk screening rotation
- Suspicious or positive findings (BI-RADS 3 or 4)
Certitude is intended for women following screening mammography who require additional risk stratification before further imaging.
It is most appropriate for:
The test has not been evaluated in individuals with a personal history of cancer (except non-melanoma skin cancer), autoimmune disorders, or during pregnancy.
Comparing Breast Cancer Screening Tests
Certitude can support decision-making within the dense breast screening pathway when mammography is negative, equivocal or inconclusive.
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.
Certitude Performance
Certitude's clinical utility is in reducing the number of patients who need additional imaging while maintaining high sensitivity for women with dense breast tissue. Certitude is a blood-based breast cancer screening test designed to support additional risk stratification following mammography.
93%
Sensitivity
Sensitive and Specific Early-Stage Breast Cancer Detection using Deep Proteome Profiling from Plasma
Drake (Breast Cancer: Targets and Therapy 2026)
90%
Sensitivity in Dense Breast
A Plasma-based Deep Proteomic Platform for Early-Stage Breast Cancer Detection
Horrmann (Endocrinology 2026)
91%
Sensitivity in High Risk Dense Breast
Deep Plasma Proteomics for Early-Stage Breast Cancer Detection
Advani (AACR 2026)
>93%
NPV
Based on Study Results for Benign Breast Conditions vs Cancer
>99%
Negative Predictive Value (NPV)
Based on Population Level Breast Cancer Prevalence
How does Certitude Work?
How the Breast Cancer Blood Test Works
Sample Processing
Blood Sample
Protein Isolation
Peptide Generation
Protein Analysis
Data Analysis
Protein Identification
Machine Learning
Cancer Proteins Detected
Certitude employs proprietary proteomic analysis to map patterns of circulating protein expression that are distinctly correlated with breast malignancy. These highly specific biomarkers are processed by sophisticated machine-learning algorithms — trained on extensive, clinically validated datasets — to deliver accurate, reproducible results.
Certitude is an Innovative, CLIA-certified, CAP-accredited Blood Test Developed by Astrin Biosciences
The test uses deep plasma proteomics and machine-learning analysis to identify circulating protein patterns associated with breast malignancy.
Elevate Early Detection
Identify molecular signatures of breast cancer even when imaging is equivocal or inconclusive
Strengthen Clinical Decision-Making
Integrate objective proteomic data with imaging findings and patient risk profiles to guide patients in their screening journey
Maximize Patient Compliance
A familiar, non-invasive blood draw minimizes anxiety and can be conveniently incorporated into any routine office visit
Enable Shared Decision-Making
Provide women with dense breasts a clear path toward more informed and proactive screening next steps
To help contextualize Certitude’s clinical utility, the table below compares its performance with mammography and MRI.
| Detection | |
|---|---|
| Mammography | Limited visibility in dense tissue |
| Certitude Test | High sensitivity with 99% NPV |
| MRI | High sensitivity, frequent false positives |
| Patient Experience | |
|---|---|
| Mammography | Compression, radiation exposure |
| Certitude Test | Simple, standard blood draw |
| MRI | Time-intensive, expensive, limited access |
| Accessibility | |
|---|---|
| Mammography | Widely available |
| Certitude Test | Broadly accessible via standard labs |
| MRI | Specialist centers only |
| Use Case | |
|---|---|
| Mammography | Primary screening |
| Certitude Test | Rule out test before follow-up imaging |
| MRI | Follow-up/High-risk imaging |
Just Blood. No Sweat. No Tears.
Certitude integrates effortlessly into any clinical setting — requiring no new equipment or complex logistical changes.
Workflow Process
Contact Certitude to establish your account. Receive onboarding support and ordering access.
No Abnormal Protein Pattern Detected: Indicates that no additional testing is needed. Continue routine screening.
Abnormal Protein Pattern Detected: Indicates additional testing is needed. It does not necessarily mean cancer. It signals the need for further evaluation. Next steps are typically to administer a mammogram, ultrasound, or breast MRI as a confirmatory test as determined by the treating provider's discretion and judgement.
Equivocal Protein Pattern Detected: The test did not determine a clear normal or abnormal result. This result is highly dependent on clinical context. Next steps could be continuing routine screening or recommending additional testing.
Coverage & Support
- We are actively working on establishing insurance coverage for the Certitude test.
- The Certitude test is available via self-pay. Patients will have to cover the out-of-pocket cost.
- Patients may be able to use pretax dollars in their flexible spending account (FSA) or health savings account (HSA) to pay for the Certitude test.
Straightforward Out-of-Pocket Pricing
Certitude is currently available at our introductory self-pay rate through our Early Access Program.
Certitude Test
For a limited time, the Certitude test is available at the introductory self-pay rate.*
The $525 introductory price includes:
Test kit, sample processing, digital results
No hidden fees
*Introductory pricing is available to eligible patients who request the Certitude test on or before December 31, 2026. We anticipate the future list price for the Certitude test will be $750 or more after the introductory pricing period ends. Pricing may vary depending on the practice setting or healthcare provider who orders the test.
How does this compare to other breast cancer screening costs?
| Breast Cancer Screening Test Options | Out-of-Pocket Costs* |
|---|---|
| Certitude test | $525 (list price $750) |
| 2-D mammogram | $100$350 |
| 3-D mammogram (DBT) | $100$600 |
| Breast ultrasound | $200$800 |
| Contrast-enhanced mammography (CEM) | $200$1000+ |
| Breast MRI (full) | $700$3000+ |
| Abbreviated (fast) breast MRI | $250$500+ |
*Regional & facility variantion is large
Frequently Asked Questions
Follow Us
Connect with us on our social channels for news about breast health