With the Certitude Test, you get Accuracy and Answers.
It’s finally here — a new way to detect breast cancer as early as Stage 0.
~50% of women have dense breastsCleveland Clinic- Someone with dense breasts is ~2x more likely to develop breast cancerHolt DB, JAMA 2026, Lynge E, et al. Int J Cancer 2023
- 15% of women are high riskJiang, et al. (JCO Clin Cancer Inform 2019)
Who is this test for?
Certitude is for women 40+ who:
- Have dense breast tissue or inconclusive mammogram results
- Have a family history or elevated risk of breast cancer
- Need an additional layer of screening beyond mammography
- Want the peace of mind
The test has not been evaluated in individuals with a personal history of cancer (except non-melanoma skin cancer), autoimmune disorders, or during pregnancy.
What is Certitude?
Peace of Mind From a Breast Cancer Blood Test
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 the Certitude Breast Cancer Blood Test 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.
93%
Sensitivity
Drake (Breast Cancer: Targets and Therapy 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)
93% Sensitivity: This means the test correctly finds cancer about 93 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 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.
Comparing Breast Cancer Screening Tests
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.
Comstock et al. (JAMA 2020)
Pötsch et al. (Radiology 2020)
Getting Certitude is Simple
Get screened in four simple steps
There are two ways to request Certitude. Choose the option that works best for you.
Option 1
Ask Your Healthcare Provider
Talk with your healthcare provider about whether Certitude may be right for you. Our Discussion Guide can help you start the conversation and know what questions to ask.
Download the Discussion GuideOption 2
Request Through Telehealth
Prefer to get started online? You can request Certitude through OpenLoop Health. A licensed healthcare provider will review your information and determine whether the test is right for you.
Request Certitude
OpenLoop provides the telehealth platform and healthcare provider network used to review your request for Certitude. Its nationwide network connects patients with credentialed providers and supports virtual care across all 50 states.
What Patients Say
“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.”
“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.”
“Peace of mind means everything to me. After my own experience with cancer, I know how much early detection can matter. I’m less afraid of cancer than I am of not catching it early. Anything that can make detection easier and more accessible gives me more confidence - not just for myself, but for my daughter, too.”
What Providers Say
“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 LevyChief Medical Officer at Visana Health and Clinical Professor at George Washington University and UC San Diego Health“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. ParkProminent breast cancer physician-scientist
Understanding Your Results
Straightforward Out-of-Pocket Pricing
For a limited time, eligible patients can request the Certitude test at the introductory self-pay price of $525.
Certitude Test
Testing will be available through our telehealth provider beginning in September 2026. To take advantage of the introductory price, your test request must be submitted by December 31, 2026. There is no requirement to complete your blood draw by December 31 to receive the introductory price.
While insurance coverage is not currently available, you may be able to use your Flexible Spending Account (FSA) or Health Savings Account (HSA) to pay for the Certitude test. You should consult your plan administrator regarding eligibility and reimbursement requirements to confirm.
The $525 introductory price includes:
Test kit, sample processing, digital results
No hidden fees
Payment handled through the patient portal
Request your Certitude test by December 31, 2026, to lock in the introductory self-pay price of $525.*
*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. The pricing above is for ordering the test directly through our patient portal. If ordered separately by your physician, pricing may vary and depend on any additional services provided to you by your healthcare provider.
Frequently Asked Questions
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