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Pathology
PreciseBreast
by PreciseDx · US
CLIA lab test that scores breast cancer recurrence risk from H&E slides and clinical factors, for oncologists and pathologists.
On this page
21/100
Not rated: too little independent evidence yet.
- Regulatory & Compliance0/28
No FDA clearance listed
- Clinical Integration0/6.6
No EHR integrations listed
- Evidence Strength12.3/28.8
1 peer-reviewed paper
- Vendor & Market3/18
Seed-stage or unfunded
- Sentiment & Transparency2.5/5
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance0/18
No FDA clearance listed
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/4
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/2
None of the top-3 EHRs covered
- Peer-reviewed papers8/21
1 peer-reviewed paper
- RCT / meta-analysis / systematic review4/8
1 observational study (no RCT)
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market0/6
Founded year not recorded
- Pricing transparency3/5
Pricing on request, no public amounts
CLIA lab test that scores breast cancer recurrence risk from H&E slides and clinical factors, for oncologists and pathologists.
No public price.
Evidence record
No FDA decision cited in our research as of November 2, 2026.
1 study on PubMed: 1 observational, published 2025. Read the literature summary
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, PreciseBreast record, https://medaiverdict.com/tools/precisedx, version November 2, 2026
Bottom line
PreciseBreast is a CLIA laboratory test, and the vendor's Series B release says it passed the New York State Department of Health's Clinical Laboratory Evaluation Program assay validation review. It scores recurrence risk from digitized H&E slides plus clinical factors for "newly diagnosed women with invasive ductal carcinoma HR+, HER2-, Node -/+ (1-3), any menopausal status, no prior treatment." Oncologists are the first audience the homepage names, followed by surgeons, pathologists, payors and patients. Anyone with a different subtype or prior treatment falls outside that population, and a practice that must order this month faces an open question, since the vendor said in June 2025 that commercial launch was planned for 2026 and its site offers a contact form and a portal login.
What does the test do?
PreciseBreast uses the vendor's OncoIntelligence platform to combine an AI-derived grade with key clinical factors into an OncoIntelligence Score. It reads cellular morphology on the slides pathologists already use for tumor grading and sorts patients into a low or high recurrence risk cohort, with results "in hours."
The vendor says gene expression tests take up to 6 weeks and cost "more than $4,000." Sold as a CLIA lab service, it has no 510(k) record under PreciseDx, and the vendor mentions no FDA clearance or Breakthrough designation. CAP accreditation is not stated.
How strong is the published validation?
Three papers on the product are vendor-affiliated. A 2022 development and validation in Breast Cancer Research (PMID 36539895) used a Mount Sinai cohort to predict recurrence within 6 years. A 2024 analytical validation (PMID 38114366) and a 2024 U.S. payer budget-impact model (PMID 39010830) followed. A 2025 paper (PMID 40836358) validated PreciseBreast in an external early-stage cohort from the Netherlands, which makes it the closest to independent, and its authorship is open.
The vendor adds a 2024 SABCS poster on a Baptist Health Miami and COTA cohort plus three SABCS 2025 abstracts. It claims clinical validation "in more than 1,600 breast cancer cases" and describes treatment-benefit prediction trials as ongoing.
How does it compare?
Against Oncotype DX, the vendor's own poster reports equivalence. Stratipath Breast and Waiv's RlapsRisk BC also profile breast cancer prognosis from H&E slides.
What does PreciseBreast cost?
PreciseDx publishes no list price. Its only figure is relative: "30% the cost of gene expression testing," a vendor claim.
Who funds PreciseDx?
The company has offices in New York and Coral Gables, Florida. A $20.7 million Series B on August 21, 2024, led by Eventide with Labcorp, Quest Diagnostics and GenHenn Capital, took total funding to $31.5 million. An $11 million round on June 18, 2025, led by Eventide with Merck Global Health Innovation Fund and Philips Ventures, took it past $43 million, and CEO Eric Converse and CFO Ed Sitar were named the same day.
The verdict
An oncology team treating HR+, HER2-negative early invasive ductal disease that wants a slide-based alternative to gene expression testing can weigh the validation record, with the Dutch cohort paper the closest to independent. Practices treating other subtypes sit outside the stated population. The vendor's June 2025 release put commercial launch in 2026, and no list price is published.
Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | Not stated | Not stated | No public price. |
Source: vendor pricing page. Last checked November 2, 2026.
What the literature says
1 peer-reviewed study indexed on PubMed evaluate PreciseBreast in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- External validation of precisebreast, a digital prognostic test for predicting breast cancer recurrence, in an early-stage cohort from the Netherlands. (opens in new tab)
- Westenend PJ, Meurs C, Fernandez G, et al.· Breast Cancer Res· 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. We retrospectively analyzed PDxBR in a cohort of 739 patients with early-stage hormone receptor-positive, HER2-negative breast cancer (median follow-up of 8.8 year…
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