A NEW STANDARD OF CARE
Our mission at PreciseDx® is to deliver objective, accurate and reliable reporting of key clinical information within hours, to improve comprehensive decision-making for patients affected by cancer.
PreciseDx allows cancer specialists to confidently formulate a comprehensive review of their patient's specific tumor, allowing for a more informed care plan.
94%
Negative Predictive Value*
98%
Reproducibility and Repeatability**
99%
Intra-Lab Concordance**
*Fernandez, G., Prastawa, M., A.S. et al. Breast Cancer Research 2022
**PreciseDx's "Analytical Validation of a Digital Breast Cancer Test Predicting Recurrence in Early-Stage Breast Cancer", Clinical Breast Cancer, Nov 2023
The science
We’ve long known that the secrets of cancer can be seen directly in their cellular structure, but in the past we could only look at that structure qualitatively. PreciseDx changes that.
PreciseBreast® uses OncoIntelligence™, our proprietary AI-platform, to combine AI-grade with key clinical factors to produce an OncoIntelligence Score™.
PreciseBreast®, clinically validated in more than 1,600 breast cancer cases, accurately and reliably stratifies patients in to two cohorts based on risk of disease recurrence up to 8.8 years.
1) Gerardo Fernandez et al, 2022. Development and validation of an AI-enabled digital breast cancer assay to predict early-stage breast cancer recurrence within 6 years. Breast Cancer Research, 24(1), pp.1-11.
2) Physicians from MCI ordered the 21-gene assay for prospective clinical treatment decisions 6 years ago. This cohort represents the same patients’ stored H&E-stained glass slides that were then tested with PreciseBreast to report predicted prognostic outcomes. As reported at SABCS 2024, outcome data has been kept for these patients to match with test scores.
3) Specimen was collected from the Laboratory of Pathology, Dordrecht Albert Schweitzer Hospital, the Netherlands on patients that were prospectively tested with the 70-gene assay for prospective clinical treatment decisions 6 years ago. This cohort represents the same patients’ stored H&E-stained glass slides that were then tested with PreciseBreast to report predicted prognostic outcomes. As reported at ESMO 2024, outcome data has been kept for these patients to match with test scores.
4.) Westenend PJ et al. Breast Cancer Res. 2025 Aug 20;27(1):152
Aug 20, 2025
External validation of PreciseBreast, a digital prognostic test for predicting breast cancer recurrence, in an early-stage cohort from the Netherlands
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Aug 20, 2025
Current clinical guidelines recommend gene expression profiling to guide treatment in early-stage breast cancer. PreciseBreast (PDxBR) is a digital prognostic tool that integrates artificial intelligence (AI)-derived features from hematoxylin and eosin (H&E) slides with clinicopathologic data to predict recurrence risk. This study externally validated PDxBR in an independent cohort and compared its performance to other risk models.
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Jun 18, 2025
PreciseDx Continues Path to Commercial Launch: Secures Additional Funding and Announces New Leadership
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Jun 18, 2025
Funding now totals over $43 million, strengthened leadership focused on a 2026 commercial launch of the OncoIntelligence™-driven, PreciseBreast™
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Dec 9, 2024
San Antonio Breast Symposium-24: PreciseBreast, an AI-enabled digital test predicting breast cancer recurrence is equivalent with Oncotype
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Dec 9, 2024
San Antonio Breast Symposium-24: PreciseBreast, an AI-enabled digital test predicting breast cancer recurrence is equivalent with Oncotype in an observational, retrospective study of patients from Baptist Health Miami Cancer Institute in partnership with COTA, Inc.
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Contact us today to learn more about PreciseBreast.
