Veracyte

Each test pairs a laboratory assay with a learned classifier. Decipher Prostate was developed, according to the discovery paper Veracyte lists, as a random forest classifier over 22 markers selected from whole transcriptome expression data, and the company's privacy notice says it uses AI and machine learning to help with its tests. What a clinician orders is the assay and its locked score: the model was trained once and does not learn from new patients, and the laboratory measurement is as much the product as the classifier.

The model is the engine of a core module, with the assay carrying value alongside it.

A test result a physician interprets against published cut points. Decipher Prostate returns a score that the treating urologist or oncologist uses with the patient, and the company's provider page reproduces the guideline text setting the low (0.45 or below) and high (0.60 or above) score groups and the treatment decisions they bear on, so an external rule governs how the score is used.

The privacy notice says staff check AI or ML results before important decisions and that no decision about a patient is made by AI without human review. What is missing is what happens after a wrong score: nothing says how a result later found inconsistent with the clinical course is reviewed.

The model and its training data are published for the flagship test, with no update practice. The Decipher discovery paper the company lists describes a random forest classifier of 22 markers trained on whole transcriptome arrays from a nested case-control cohort of 639 men from the Mayo Clinic registry, validated with an area under the curve of 0.75; Decipher Bladder uses a 219-gene classifier. The classifiers are locked panels, so versions change rarely, but no version history or statement of how a change would be validated and notified is published.

Approach and data named without the update discipline.

An in-house build run in the company's own laboratories. Veracyte develops its classifiers itself and performs Decipher and Afirma as laboratory developed tests in its own CLIA-certified laboratories, so no outside model provider sits between a sample and a score; Prosigna runs as a kit in local laboratories on the nCounter system. The privacy notice says the company uses service providers and international transfer safeguards, without naming them, and nothing identifies the hosting of the ordering portals or any outside AI tools it uses.

A structurally short chain at the model layer, with the operating chain unnamed.

Guideline inclusion rests on randomized trial evidence. Decipher Prostate is, per the company's provider page, the only gene expression test in the Advanced Tools table of version 7.2026 of the NCCN prostate cancer guidelines, which quote post hoc, prespecified analyses of phase 3 randomized trials: in NRG/RTOG 0126, 10 year distant metastasis rates of 4 percent for low scores against 16 percent for high scores after radiotherapy alone; in a meta analysis of three RTOG trials, an absolute benefit of long term over short term hormone therapy of 11 percent for high scores and 3 percent for low; and post prostatectomy results from NRG/RTOG 9601 and SAKK 09/10. The guideline text also notes where breakdowns were not provided. Prospective randomized trials including the test are under way.

Independently evaluated performance in randomized trial cohorts, with the method available.

Research use of patient data is stated, without the terms that govern it. The privacy notice says Veracyte may use information, often in a form that does not directly identify the person, to improve its products and develop new ones, and the notice of privacy practices lists de-identification among its operations; the company also offers a research-use database built from its testing. Neither says what de-identification standard applies, how long samples and data are kept, or whether a patient can opt out of research use.

General assurances that do not answer what reaches a model.

A covered entity with a published notice of privacy practices. Veracyte states that it provides laboratory testing as a HIPAA covered entity, and its notice of privacy practices (effective 18 September 2023) sets out uses and disclosures for treatment, payment and operations, de-identification, and patients' rights of access, amendment and accounting; a separate privacy notice covers its websites and services, including its use of AI and machine learning. For Prosigna kits run in local laboratories, testing happens at the customer's site. No business associate agreement template is published for the vendors Veracyte itself uses.

Status stated and supported by a substantive privacy document.

Nothing independent is published on security. The legal pages in the site footer and the privacy notice describe safeguards such as encryption, pseudonymization and access controls for international transfers, but the company publishes no SOC 2 report, ISO/IEC 27001 or HITRUST certification, trust center or penetration testing statement. The laboratory's CLIA, CAP and New York State credentials govern testing quality, not information security.

A stated laboratory developed test position, with one cleared kit. The company says Decipher and Afirma are performed as laboratory developed tests in its CLIA-certified laboratories and have not been cleared or approved by FDA, which it says is not required, and names College of American Pathologists and New York State accreditation. Prosigna is sold as a kit to local laboratories and is CE-IVD outside the United States. The locked Decipher classifier is the AI component, and its status is the laboratory developed test route.

A governing regime named precisely, with the marketing matching it.

Ancestry studies are listed, and their results come through an abstract and a company release. The company lists a prospective study in the Journal of the National Cancer Institute (2022) of 226 men, 113 African American and 113 matched non-African American, whose abstract reports that African American men with low or favorable intermediate clinical risk more often had higher Decipher scores, and a company release describes results from the VANDAAM trial presented in 2024 as showing no significant difference in performance between the two groups.

Prostate cancer mortality is markedly higher in Black men, so this is the comparison that matters most. The full papers may report performance by group in more detail. There is no governance framework or monitoring commitment beyond the privacy notice's statement that staff check AI results.

A patient can ask the laboratory to correct the result it reported. Veracyte provides these tests as a HIPAA covered entity, and its notice of privacy practices (effective 18 September 2023) gives patients the right to request in writing an amendment to protected health information in its designated record set, which includes the Decipher or Afirma result, with a written decision if the request is denied. The guideline text on the provider page gives observed 10-year metastasis rates by score group in named trial cohorts, though without event counts on the page. No warranty, indemnity or remediation commitment attaches to a score, and the kit terms for Prosigna cover the instrument, not the result.

A correction route the affected person can exercise against the vendor.

No record system integration is described. Clinicians order Decipher, Afirma and Prosigna and view reports through Veracyte's web portals, or send requisitions by email or fax, and results reach the chart the same way. Its published material names no EHR, laboratory system, interface or standard.

Two routes, each with a defined location. Decipher and Afirma are performed in Veracyte's own CLIA-certified laboratories in the United States, so samples and results rest there, while Prosigna is sold as a kit that local laboratories run on their own nCounter system, keeping data at the ordering site. The privacy notice describes safeguards for international transfers. No hosting provider or region is stated for the web portals that carry orders and reports.

Options and residency stated with the processing path for the portals left open.

No price is published; coverage is stated. Decipher Prostate is covered by Medicare and, the company says, by most major insurance plans, with financial support available to eligible patients, and TrueMRD has Medicare coverage. The tests are ordered per patient through portals, and Prosigna is sold as a kit under published kit terms. No list price, patient out-of-pocket estimate or kit price is published.

The sales posture is discoverable, with no price.

Named cancers and care points, with strong validation behind prostate. The tests cover thyroid nodules (Afirma), prostate (Decipher Prostate at biopsy, after prostatectomy and in metastatic disease), bladder (Decipher Bladder, TrueMRD monitoring and, since September 2026, the UroAmp urine test from Convergent Genomics) and breast (Prosigna). Decipher Prostate's settings are defined and supported by trial analyses; the other tests are validated to different depths, and the intended use differs by setting.

Coverage named with validation behind part of it.