PreciseDx

PreciseDx is an AI-driven oncology diagnostics company that commercializes a morphology-based risk‑stratification test, PreciseBreast, which analyzes standard H&E pathology slides to produce rapid, patient‑specific recurrence risk scores to support treatment decisions for early‑stage breast cancer patients[4][1]. The company leverages its OncoIntelligence platform and a patented Morphology Feature Array to quantify cellular morphology at scale and has raised institutional funding to expand commercialization after clinical validation and regulatory laboratory approvals[1][3].

High‑Level Overview

• Mission: PreciseDx’s stated mission is to deliver objective, accurate, and reliable reporting of key clinical information within hours to improve comprehensive decision‑making for patients affected by cancer[1].
  - Investment philosophy / Key sectors / Impact on the startup ecosystem: Not applicable — PreciseDx is a portfolio company/product company rather than an investment firm; relevant information below focuses on its role in diagnostics and oncology AI[4][1].
  - What product it builds: PreciseDx builds PreciseBreast, an AI‑powered early‑stage breast cancer risk assessment that analyzes digitized hematoxylin & eosin (H&E) slides to produce a Risk of Recurrence Score using OncoIntelligenceTM and a Morphology Feature Array®[4][1].
  - Who it serves: The product serves oncologists, pathologists, and multidisciplinary cancer care teams making adjuvant treatment decisions for patients with early‑stage invasive breast cancer[4][1].
  - What problem it solves: PreciseBreast addresses subjectivity and delays in conventional tumor grading and the wait/cost associated with gene‑expression assays by providing objective, reproducible risk stratification in hours from existing pathology slides[4][1].
  - Growth momentum: PreciseDx has completed clinical validation in >1,600 breast cancer cases, obtained CLIA and NYSDOH laboratory clearances, received an AMA CPT PLA code in 2023, began commercial activities in 2023, raised a $10.75M Series A in 2021 and a $20.7M Series B in 2024 to support commercialization, and announced a Scientific Advisory Board as it commercialized PreciseBreast in 2024–2025[6][2][3][5][4].

Origin Story

• Founders and background: PreciseDx’s technology and scientific foundation trace to the work of Dr. Carlos Cordon‑Cardo and Mount Sinai researchers; the company was founded in 2021 to translate that academic work into a commercial diagnostic service[6][2].
  - How the idea emerged: The company emerged from academic research showing that quantifiable cellular morphology (as opposed to purely qualitative histologic grading) contains predictive signals; PreciseDx built an AI platform (OncoIntelligence) and the Morphology Feature Array to extract those signals from routine H&E slides[1][2].
  - Early traction / pivotal moments: Key early milestones include clinical validation studies (>1,600 cases reported), CLIA and New York State Department of Health (NYSDOH) laboratory approvals in 2022, obtaining an AMA CPT PLA code in 2023, Series A funding in 2021, Series B funding in 2024, and commercial launch activities culminating in broader commercialization of PreciseBreast during 2024–2025[6][2][3][4].

Core Differentiators

• Product differentiators: Uses morphology‑driven AI (Morphology Feature Array®) to quantify every cell on standard H&E slides and combine those features with clinicopathologic data to produce patient‑specific risk scores, rather than relying solely on gene‑expression assays or subjective grading[1][3].
  - Speed and workflow: Provides risk stratification results in hours from existing pathology slides—shortening a process that can take 2–6 weeks for gene‑expression tests—enabling faster treatment planning and reduced patient anxiety[4].
  - Analytical performance and validation: Company cites high reproducibility and reproducible performance metrics from validation studies (e.g., high intra‑lab concordance and repeatability reported in peer‑reviewed/internal validation publications)[1].
  - Regulatory & reimbursement progress: CLIA and NYSDOH laboratory certification achieved in 2022 and an AMA CPT PLA code granted in 2023, supporting clinical adoption and billing pathways[6][4].
  - Clinical evidence base: Clinical validation across thousands of cases and peer‑reviewed publications underpin the model’s claimed ability to stratify recurrence risk up to ~8.8 years in retrospective cohorts[1][4].

Role in the Broader Tech Landscape

• Trend alignment: PreciseDx rides two major trends: AI/digital pathology adoption and the push to deliver precision oncology using existing clinical data streams (digitized histology) rather than costly molecular assays[4][1].
  - Why timing matters: Rapid digitization of pathology labs, growing regulatory frameworks for AI in medicine, and pressure to reduce diagnostic turnaround time and cost create a receptive market for morphology‑based AI assays[3][4].
  - Market forces in its favor: Demand for scalable, lower‑cost prognostic tools, value‑based oncology care emphasizing appropriate use of adjuvant therapy, and payer interest in clinically validated diagnostics all support uptake of objective risk‑stratification tools[3][1].
  - Influence on ecosystem: If broadly adopted, morphology‑driven AI tests like PreciseBreast could shift some diagnostic workflows away from expensive gene‑expression tests for particular use cases, accelerate integration of digital pathology into routine care, and spur additional AI companies to validate morphology‑first approaches[4][1][3].

Quick Take & Future Outlook

• What’s next: PreciseDx is focusing on commercial expansion of PreciseBreast while developing additional oncology assays (prostate cancer is noted in development) and growing clinical and payer adoption supported by its Series B financing[3][2].
  - Trends that will shape their journey: Wider digital pathology adoption, prospective clinical utility studies, payer coverage decisions, and comparative effectiveness versus gene‑expression assays will determine clinical penetration and reimbursement[4][3].
  - How influence might evolve: With robust clinical validation and reimbursement, PreciseDx could become a mainstream, lower‑cost alternative or complement to molecular assays in selected oncology indications and an exemplar for morphology‑based AI diagnostics; conversely, broad adoption will require continued demonstration of clinical utility, integration into pathology workflows, and payer acceptance[1][3][4].
  

Quick take: PreciseDx is a clinically validated, well‑funded startup translating Mount Sinai’s academic AI pathology research into a commercial, morphology‑based risk‑stratification test that aims to deliver faster, objective recurrence risk information from routine H&E slides—positioning it to accelerate adoption of digital pathology and tighter, data‑driven oncology decision making if it continues to demonstrate real‑world clinical utility and secures reimbursement[1][4][3].