Delphi Diagnostics

What Delphi Diagnostics does

Delphi Diagnostics Inc. is a Texas-incorporated, privately held molecular diagnostics company founded in 2016, headquartered at 8515 Fannin St., Suite 105, Houston, TX (with operating presence also in Austin). The company operates a CAP/CLIA-accredited laboratory that commercializes the Endocrine Activity Index (EAI), an 18-gene expression profiling assay measuring transcriptional activity related to Estrogen Receptor (ER) and Progesterone Receptor (PR) in Stage II–III, HR+/HER2− breast cancer tumor tissue. EAI is the first and only genomic assay shown to predict benefit from contemporary taxane-based chemotherapy regimens, addressing a clinical decision gap left by recurrence-risk-only tests such as Oncotype DX and MammaPrint. The broader portfolio includes the Endocrine Activity Index Recurrence Risk (EAI RR) — which combines EAI with baseline prognostic factors (RNA4 molecular subtype, pathologic tumor size, nodal status) — and the SET2,3 Index used in adaptive trial randomization. The technology is licensed exclusively worldwide from The University of Texas MD Anderson Cancer Center based on work by co-founder Dr. W. Fraser Symmans, and is protected by US Patent No. 11,459,617 (through 2037) with granted EU and allowed Japanese counterparts.

Delphi's business model is a fee-for-service laboratory testing operation: healthcare providers (breast surgeons, medical oncologists, cancer centers) order the EAI or EAI RR test, tumor tissue from prior surgery or biopsy is shipped to Delphi's Houston laboratory, and results are returned within approximately 14 days to inform chemotherapy-regimen selection and prognosis. Go-to-market is enterprise-focused, leveraging direct sales through Medical Science Liaisons, presence at major oncology conferences (ASCO, SABCS, ESMO Breast Cancer), peer-reviewed publications in journals such as Journal of Clinical Oncology, Clinical Cancer Research, European Journal of Cancer, and Annals of Oncology, and clinical-trial partnerships including inclusion in the I-SPY 2 platform trial. The company has scaled distribution through a 2024 strategic partnership with Protean BioDiagnostics and launched an Early Access Program the same year. Pricing is not publicly disclosed and operates through standard healthcare reimbursement channels.

The company has completed three capital raises backed by family offices, professional investors, and Silicon Valley impact VC DigitalDX Ventures. Leadership includes founder/CEO/Chair Winz Casagrande, CFO Eric Lindquist (effective April 2026, with prior senior roles at Natera, Celcuity, InnoSIGN, and Roche), Chief Medical Officer Dr. Federico A. Monzon (formerly of Castle Biosciences and Invitae), Chief Commercial Officer J. Chuck Morrison (formerly PerkinElmer), and an advisory bench including former Genomic Health CEO Kim Popovits and former Exact Sciences Precision Oncology GM Gisela Paulsen. The clinical evidence base spans 7 randomized trials (CALGB 9741, GEICAM/9906, SWOG S8814, PACS-01, PALLAS, NRG/NSABP B-42, I-SPY 2) covering more than 4,600 patients and 10+ peer-reviewed publications.

Name

Delphi Diagnostics

Legal name

Delphi Diagnostics Inc.

Website

https://delphi-diagnostics.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

Delphi Diagnostics is a Houston-based molecular diagnostics company commercializing the 18-gene Endocrine Activity Index (EAI) test, which predicts benefit from taxane-based chemotherapy in Stage II-III HR+/HER2- breast cancer. It serves breast surgeons, oncologists, and cancer centers via a CAP/CLIA laboratory under an exclusive MD Anderson Cancer Center license.

Ownership category

akta.pro rank

Product category

Breast Cancer Diagnostics

NAICS

Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI)

Keywords

• Genomic diagnostic testing
• Breast cancer diagnostics
• Gene expression profiling
• Molecular diagnostic assays
• Clinical laboratory services

Headquarters

HQ city

Austin

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Laboratory Diagnostic Testing Services: Delphi Diagnostics provides genomic testing services where healthcare providers order the Endocrine Activity Index test. Tumor tissue samples are sent to the company's CAP/CLIA-accredited laboratory in Houston, TX for analysis. Results are returned to physicians to guide breast cancer treatment decisions. The company operates on a fee-for-service laboratory testing model.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Delphi Diagnostics provides laboratory diagnostic testing services centered on the Endocrine Activity Index (EAI), an 18-gene expression profile assay that measures transcriptional activity related to Estrogen Receptor (ER) and Progesterone Receptor (PR) in Stage II-III, HR+, HER2- breast cancer tumor tissue. Healthcare providers order the test, tumor samples are sent to Delphi's CAP/CLIA-accredited laboratory in Houston, TX, and results are returned to physicians to inform chemotherapy regimen selection and recurrence risk assessment.

Product overview

Delphi Diagnostics offers a unified diagnostic platform centered on the Endocrine Activity Index (EAI) technology, which includes two related products: the Endocrine Activity Index (EAI) for predicting benefit from dose-intense paclitaxel-based chemotherapy, and the Endocrine Activity Index Recurrence Risk (EAI RR) for refined breast cancer prognosis. Both products are 18-gene expression profile tests that measure endocrine transcriptional activity in Stage II-III, HR+, HER2- breast cancer tumors. EAI provides predictive information for chemotherapy selection, while EAI RR combines the endocrine activity measurement with baseline risk factors for enhanced prognostic assessment.

Differentiator

Problem solved

Functional benefit

Brands

• Endocrine Activity Index (EAI): An 18-gene expression profile test measuring transcriptional activity related to Estrogen Receptor and Progesterone Receptor in Stage II-III breast cancer tumor tissue.
• Endocrine Activity Index Recurrence Risk (EAI RR)

Products and services

• Endocrine Activity Index (EAI) An 18-gene expression profile test that measures transcriptional activity related to Estrogen Receptor (ER) and Progesterone Receptor (PR) in Stage II-III, HR+, HER2- breast cancer tumor tissue. Patients with low endocrine activity (EAI <0.75) demonstrate improved survival when treated with dose-intense paclitaxel-based chemotherapy. The test is the first and only genomic assay shown to predict benefit from taxane-based chemotherapy regimens in HR+/HER2- breast cancer.
• Endocrine Activity Index Recurrence Risk (EAI RR) Combines the genomic measurement of endocrine activity with baseline tumor and patient risk factors including molecular subtype genes (RNA4), pathologic tumor size (pT), and nodal status (pN) to inform breast cancer prognosis and recurrence risk assessment. Shown to be a consistent prognostic indicator for long-term outcomes in Stage II-III breast cancer, independent of other prognostic tests.

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered core.

• Protean BioDiagnosticscoreStrategic or Co-development Partner · 2 April 2024Delphi Diagnostics entered a strategic partnership with Protean BioDiagnostics, a CAP/CLIA-accredited laboratory headquartered in Orlando, FL specializing in advanced cancer diagnostic technologies. This collaboration allows Delphi to expand capacity to participate in additional clinical trials and begin an Early Access Program in 2024. Protean's expertise in developing and deploying laboratory tools complements Delphi's technology to help scale and bring EAI to more breast cancer patients.
• Quantum Leap Healthcare CollaborativecoreStrategic or Co-development Partner · 27 October 2022Delphi's SET2,3 test was included in the I-SPY 2 TRIAL adaptive randomization process for patients with locally advanced breast cancer. SET2,3 helps determine which patients with HR+ tumors will benefit from endocrine therapy. The test is used in the Endocrine Optimization Pilot (EOP) sub-study of I-SPY 2. The I-SPY 2 TRIAL is the longest-running platform trial globally with over 1,400 patients enrolled.
• The University of Texas MD Anderson Cancer CentercoreOEM/ Whitelabel/ Licensing PartnerDelphi Diagnostics holds an exclusive worldwide license from MD Anderson Cancer Center in Houston, TX to commercialize past, present, and future breast cancer diagnostics and intellectual property developed by Dr. Fraser Symmans. The EAI technology was developed by Dr. Symmans' laboratory. Dr. Symmans serves on the I-SPY Pathology Working Group and chairs it.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Exact Sciences: Acquired Genomic Health and now markets Oncotype DX, the dominant breast cancer recurrence score test. Competes head-to-head with Delphi's EAI for inclusion in adjuvant treatment decision-making for HR+/HER2- breast cancer patients.
• Veracyte: Genomic diagnostics company with oncology products including Prosigna (PAM50-based breast cancer assay). Overlaps with Delphi in providing molecular prognostic/predictive information for breast cancer treatment decisions.
• Natera: Specializes in cell-free DNA and molecular diagnostics, including Signatera MRD test in oncology. Delphi's incoming CFO Eric Lindquist previously helped launch Signatera, and Natera represents a comparable molecular oncology diagnostics commercial platform.
• NeoGenomics: Provides oncology-focused clinical laboratory services including comprehensive genomic profiling. Operates a CAP/CLIA-accredited lab serving oncologists, comparable to Delphi's CAP/CLIA service model for breast cancer providers.
• Guardant Health: Liquid biopsy leader with Guardant360 and Reveal assays. While focused on blood-based testing rather than tissue-based expression profiling like Delphi, Guardant is expanding into breast cancer MRD and treatment selection, representing an adjacent competitive threat.

Direct peers

• Agendia: Markets MammaPrint and BluePrint, genomic assays that provide recurrence risk and molecular subtyping for breast cancer. Competes with Delphi in the same HR+/HER2- adjuvant decision-making niche with established guideline inclusion and payor coverage.
• Castle Biosciences: Commercial-stage molecular diagnostics company whose DecisionDx assays guide oncology treatment. Delphi's CMO Dr. Federico Monzon was previously CMO at Castle, indicating direct strategic and operational overlap in oncology test commercialization.
• Biotheranostics: Markets Breast Cancer Index (BCI), a genomic test predicting benefit from extended endocrine therapy in HR+ breast cancer. Direct competitor to Delphi's EAI extended endocrine therapy use case for the same patient population.

Emerging players

• Caris Life Sciences: Provides molecular profiling services including MI Profile and Caris Assure for cancer treatment guidance. Emerging competitor offering broad tumor profiling that could be positioned as an alternative to single-indication assays like EAI.

Others

• Inivata (acquired by NeoGenomics): Liquid biopsy technology acquired by NeoGenomics. Relevant as an example of a smaller molecular diagnostics player consolidating into a larger oncology lab services platform, illustrating the likely exit pathway for Delphi.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/delphi-diagnostics-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds2 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Delphi Diagnostics