PreciseDx

The model is the product. PreciseBreast's score combines an AI grade, computed from cell and tissue patterns on the H&E slide, with tumor size, node status and age. Those clinical factors are already in the patient's chart, so without the AI grade there is no test to sell. PreciseDx offers no other product or service beside it.

Ask how much of the risk score comes from the AI grade and how much from the clinical factors, and how the score behaves when the two point in different directions.

Results go to an ordering clinician, and the controls around the score are not described. Oncologists, surgeons and pathologists order PreciseBreast and get it back as a laboratory result, so a clinician decides what the risk group means for treatment.

PreciseDx publishes nothing on whether a pathologist reviews the AI grade or the tumor outline before release, when a slide is rejected as unsuitable, how the cut point between low and high risk was set, or how a score near the cut point is reported.

Ask who reviews each result before release, the slide quality criteria that stop a test, and how borderline scores are reported.

PreciseDx names and has published its approach, without a version or update practice. It describes the OncoIntelligence platform as outlining the tumor, deriving an AI grade from cell and tissue patterns on H&E slides, and combining it with tumor size, node status and age. The method was published in Breast Cancer Research in 2022.

No model version is published, and the training data is described only as Mount Sinai cases. Nothing describes how the model or the cut point is updated, or how ordering clinicians are told.

Ask for the model version in production, what changed since the 2022 publication, and whether a model change can move a past patient's risk group.

PreciseDx developed its own model from Mount Sinai pathology research and runs it in its own laboratory, so no outside model provider sits between a slide and a result. The notice says business associates must protect patient information, without naming them. No hosting provider or subprocessor list is published.

Ask for the processors and hosting provider that handle slide images and results.

Peer reviewed validation comes from the founding institution, looking back at past cases, with other comparisons reported more briefly. The method and its validation on more than 1,600 breast cancer cases from Mount Sinai were published in Breast Cancer Research (Fernandez and colleagues, 2022), by the founders.

A comparison with Oncotype in a gene expression tested cohort from Baptist Health Miami, with COTA, was presented at SABCS 2024 as showing equivalence. An outside validation in an early stage Dutch cohort was reported in August 2025. PreciseDx also reports 98 percent precision and reproducibility in tumor segmentation and less than 2 percent variation in the risk score.

The headline claims, equivalence with gene expression testing at lower cost and faster turnaround, rest on the conference comparison, not a peer reviewed or prospective study. The figures for the Dutch cohort are not set out on PreciseDx's pages.

Ask for the hazard ratios and recurrence rates in each risk group for every cohort, the SABCS comparison in full, and any prospective or decision impact study.

PreciseDx publishes privacy notices, without the answers the model raises. Its notice allows research use of protected health information where required legal steps are taken. Nothing published says how long slides, images and results are kept, whether patient slides are used to train or recalibrate the model, or how training data was de identified.

The model was developed on Mount Sinai cases, and no data governance terms for that archive are published. No safety engineering for the model is published.

Ask whether patient slides are used to retrain the model, how long images and results are kept, and how training data was de identified.

PreciseDx publishes the privacy notice a laboratory covered by HIPAA issues to its patients. Its Notice of Privacy Practices, effective 1 March 2025, describes how PreciseDx Inc. uses and shares protected health information and the rights patients have, including amendment. It covers research use where legal safeguards are met and the duties of business associates, and names a privacy contact. The notice shows PreciseDx's role as a covered entity, though it does not state it in words.

A separate consumer health data privacy policy and a website privacy policy are also published. No agreement for health system or payer partners is published.

Ask for confirmation of PreciseDx's role for each program, and the business associate terms where it works under a health system's agreement.

PreciseDx publishes no security audit or certification. It describes itself as HIPAA compliant and publishes privacy notices. No SOC 2 report, ISO/IEC 27001 certificate, HITRUST certification, penetration testing statement or trust center appears on its site.

CLIA certification, New York State certification and CAP accreditation cover laboratory quality, not information security.

Ask for a current security attestation with its scope and date.

PreciseDx makes no device claim, and offers the test as a laboratory developed test under state and federal laboratory rules. It describes a CLIA certified laboratory and New York State Department of Health certification, both from 2022, and CAP accreditation. The FDA's databases list no PreciseDx device, and no FDA position is stated. State certification governs the laboratory itself.

The test is marketed as equivalent to gene expression testing for recurrence risk. A buyer should weigh that clinical claim against a status that rests on laboratory regulation alone.

Ask whether New York State approved PreciseBreast specifically, and whether any FDA submission is planned.

PreciseDx claims analytical consistency, but publishes no results by group. It reports 98 percent precision and reproducibility in tumor segmentation and less than 2 percent variation in the risk score. It does not give the number of slides, scanners, operators or sites behind those figures. It reports validation in three cohorts, without results compared across age, menopausal status, node status, race or ethnicity, or scanner on its pages.

Breast cancer recurrence risk and tumor appearance differ by age and ancestry, which is where a model that reads tumor appearance is most likely to underperform. No governance process or monitoring after release is described.

Ask for reproducibility data with counts by scanner and site, and for recurrence prediction by age group, node status and race or ethnicity.

PreciseDx reports the result as the laboratory, and its privacy notice gives the patient a route to correct it. The risk group is the AI driven result the laboratory reports. Under the Notice of Privacy Practices, a patient can ask PreciseDx in writing to amend information, and PreciseDx answers in writing whether it accepts or denies the request. No time limit is stated.

No error rate at the risk cut point, warranty, retesting commitment or indemnity is published.

Ask for the recurrence rate in the low risk group and the share of recurrences classed low risk, with the cohort, and what PreciseDx does when a reported result is found to be wrong.

PreciseDx publishes no integration. Its pages for oncologists cover billing and the patient assistance program. They name no ordering route through a record system, no results interface, no laboratory information system and no standard. How results reach the ordering clinician is not described.

Ask how PreciseBreast is ordered and resulted, whether an electronic interface to your record system exists, and at which health systems it runs.

PreciseBreast is a laboratory service, and where data sits is implied, not stated. Slides go to PreciseDx's own laboratory in New York or Coral Gables, Florida, and results come back as a laboratory report, so the ordering practice runs no software.

Nothing published says where digital slide images and results are stored or processed, or which cloud or hosting provider is used.

Ask where slide images and results are stored, by which provider and in which region, and how long they are kept.

No price is published, but how the test is billed can be worked out. PreciseBreast is billed per test under its own billing code, CPT 0220U. Insurance coverage varies by plan, and there is a patient assistance program and interest free payment plans of up to six months.

PreciseDx says the test costs 30 percent of gene expression testing, a comparison that gives no figure.

Ask for the list price, the Medicare payment for 0220U, and the typical patient cost under commercial plans.

PreciseDx names the eligible patients precisely, with validation behind part of that group. PreciseBreast is for untreated, early stage, hormone receptor positive, HER2 negative invasive ductal carcinoma with no or one to three positive lymph nodes, at any menopausal status. It predicts recurrence over up to 8.8 years.

Validation covers a Mount Sinai cohort of more than 1,600 cases, a Baptist Health Miami cohort and a Dutch cohort. PreciseDx's pages do not show results separately for node positive patients or for tumor types other than invasive ductal carcinoma. Oncologists and surgeons order it as a prognostic laboratory test, which is why PreciseDx is also listed under diagnostics and genomics.

Ask for results in node positive and premenopausal patients specifically, and how lobular or mixed histology is handled.