MeCo Diagnostics

What MeCo Diagnostics does

MeCo Diagnostics is a San Diego-based, venture-backed private company developing the MeCo Score, a first-in-class predictive biomarker test that measures tumor extracellular matrix stiffness (mechanical conditioning) from existing biopsy tissue to identify early-stage, high-risk HER2-negative breast cancer patients likely to benefit from FDA-approved antifibrotic therapy (nintedanib). The underlying science originated from a decade of NCI-funded research beginning in 2014 and is led by CEO Adam Watson (PhD) and CSO Gus Mouneimne (PhD), with KOL-affiliated collaborators at Cleveland Clinic, George Washington Cancer Center, City of Hope, and CNIO. Clinical validation rests on a 130-patient Phase 2 study with 9.7 years of median follow-up, published in Clinical Cancer Research (2024), demonstrating a 62% reduction in recurrence risk (p=0.031) for high MeCo Score patients receiving nintedanib plus chemotherapy versus chemotherapy alone.

The MeCo Score test is designed as a drug-, pathway-, and mechanism-of-action-agnostic companion diagnostic, enabling forward compatibility with second-generation antifibrotic therapies. Because the assay uses existing biopsy material, it requires no additional procedures for most patients, and the underlying drug (nintedanib) is a generic, positioning the combined regimen at >10X lower cost than alternative targeted breast cancer therapies.

The company's business model is pre-commercial: the test is currently labeled for Investigational Use Only and is not FDA cleared or approved. The intended revenue mechanics, once cleared, are laboratory testing services (one-time per-patient diagnostic fees) and companion diagnostic licensing royalties from pharmaceutical partners developing antifibrotic therapies. Go-to-market targets oncologists and cancer treatment centers, with reimbursement pursued via publication in CMS-endorsed oncology journals. To date, the company has raised approximately $1.0M in angel financing (GoAhead Ventures 2023; Seattle Angel Conference and Team Ignite Ventures 2024) and secured a €320,000 (~$378,000) three-year Spanish government grant flowing to CNIO in February 2026 to advance clinical evaluation.

Name

MeCo Diagnostics

Legal name

MeCo Diagnostics Holdings, Inc.

Website

https://mecodiagnostics.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

MeCo Diagnostics develops the MeCo Score, a first-in-class predictive biomarker test that uses existing biopsy tissue to identify HER2-negative breast cancer patients likely to benefit from FDA-approved antifibrotic therapy (nintedanib). The company serves oncologists and cancer centers and is currently pre-commercial, with the test designated for Investigational Use Only.

Ownership category

akta.pro rank

Product category

Companion Diagnostics / Oncology Biomarker Testing

NAICS

Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Predictive biomarker diagnostics
• Companion diagnostic tests
• Oncology biomarker assays
• Antifibrotic therapy selection
• Breast cancer diagnostics

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. MeCo Score Diagnostic Test: Revenue from biomarker testing services. The MeCo Score test is currently for Investigational Use Only and not yet FDA cleared or approved. Once commercialized, the company will generate revenue through laboratory testing services, potentially reimbursed through existing oncology care pathways.
2. Companion Diagnostic Licensing: As a companion diagnostic for antifibrotic therapy, MeCo Score could generate licensing revenue from pharmaceutical partnerships and healthcare providers implementing the test. The company's drug-agnostic, pathway-agnostic design enables compatibility with second-generation antifibrotic therapies under development.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

MeCo Diagnostics develops and plans to commercialize the MeCo Score, a first-in-class predictive biomarker test that identifies early-stage, high-risk HER2-negative breast cancer patients likely to benefit from FDA-approved antifibrotic therapy (nintedanib). The test is performed on existing biopsy tissue, eliminating the need for additional procedures, and is positioned as a companion diagnostic for antifibrotic therapy in oncology. The product is currently for Investigational Use Only and not yet FDA cleared/approved.

Product overview

MeCo Diagnostics offers a single unified product, the MeCo Score™ — a first-in-class, clinically validated predictive biomarker test that identifies early-stage, high-risk breast cancer patients who may benefit from FDA-approved antifibrotic therapy. The test analyzes existing biopsy tissue to measure tumor mechanical conditioning, enabling a biomarker-enabled drug repurposing approach that augments conventional chemotherapy without requiring additional patient procedures. The MeCo Score was validated through a landmark 10-year Phase 2 clinical study with 130 patients, demonstrating a 62% reduction in recurrence risk over 9.7 years for high MeCo Score patients receiving antifibrotic therapy plus chemotherapy.

Differentiator

Problem solved

Functional benefit

Brands

• MeCo Score: The first and only clinically validated biomarker test to identify patients with early-stage, high-risk breast cancer who may benefit from FDA-approved antifibrotic therapy.

Products and services

• MeCo Score™ MeCo Score is a first-in-class, clinically validated predictive biomarker test that identifies early-stage, high-risk HER2-negative breast cancer patients who may benefit from FDA-approved antifibrotic therapy (nintedanib). The test analyzes existing biopsy tissue to measure tumor extracellular matrix mechanical conditioning (stiffness) and requires no additional procedures for most patients. It is designed to function as a companion diagnostic to antifibrotic therapy, enabling biomarker-guided treatment selection. The product is currently for Investigational Use Only and is not yet FDA cleared/approved.

Quantifiable outcome

• 62% reduced risk of recurrence over 9.7 years median follow-up for high MeCo Score patients receiving nintedanib plus chemotherapy vs chemotherapy alone (p=0.031)
• +1 more outcomes

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

Four partnerships are on record, tiered core and secondary.

• CNIO (Spanish National Cancer Research Centre)coreStrategic or Co-development Partner · 27 February 2026Dr. Miguel Quintela-Fandino at CNIO was awarded a three-year, €320,000 (~$378,000) grant from Instituto de Salud Carlos III to advance the MeCo Score for HER2-negative breast cancer. CNIO serves as a key research collaborator for clinical validation and expansion of translational datasets for antifibrotic strategies across aggressive tumor models.
• Cleveland CliniccoreStrategic or Co-development PartnerDr. Julie Lang serves as Clinical Collaborator and Chief of Breast Surgery at Cleveland Clinic. The partnership involves positive data collaboration announced on the company's news page. Cleveland Clinic represents a key clinical validation and KOL affiliation partner.
• George Washington Cancer CentersecondaryStrategic or Co-development PartnerDr. Pavani Chalasani, Associate Director at George Washington Cancer Center, serves as an advisor. Partnership involves clinical collaboration and physician-investor/KOL affiliations.
• City of HopesecondaryStrategic or Co-development PartnerDr. Yun Yen, former Director of Clinical Pharmacology at City of Hope, serves as an advisor. Represents a key physician-investor and KOL affiliation.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Exact Sciences: Exact Sciences is the leading commercial-stage cancer diagnostics company (Cologuard, Oncotype DX), making it the most relevant scaled analog for MeCo's reimbursement and commercial trajectory in oncology testing. Comparable in the sense that both develop molecular diagnostic tests that match patients to therapy or screening pathways and must clear CMS reimbursement, though Exact operates at much larger scale.
• Myriad Genetics: Myriad Genetics is a long-established leader in cancer predisposition and predictive testing (BRACAnalysis, myChoice HRD). Myriad is a broad incumbent peer offering companion-diagnostic and prognostic testing across oncology and provides a useful benchmark for MeCo's longer-term commercial and licensing economics.
• Foundation Medicine: Foundation Medicine, a Roche subsidiary, provides comprehensive genomic profiling for solid tumors and is a dominant companion-diagnostic player across many oncology indications. Foundation is the closest large-scale analog for MeCo's companion-diagnostic licensing model and its pharma partnership mechanics.
• NeoGenomics: NeoGenomics is a specialty oncology reference laboratory providing biomarker testing services to oncologists, pathologists, and pharma clients. NeoGenomics is a broad incumbent peer reflecting the centralized specialty lab business model that MeCo is positioned to operate within.

Direct peers

• Agendia: Agendia commercializes MammaPrint and MammaBluePrint, the leading breast-cancer prognostic and predictive genomic assays. MeCo's MeCo Score is the most direct conceptual analogue: both are biomarker tests run on existing biopsy tissue to guide treatment decisions in early-stage breast cancer, including identification of patients who may benefit from chemotherapy intensification.
• Veracyte: Veracyte develops genomic and molecular tests that inform cancer treatment decisions, including Prosigna for breast cancer recurrence risk. Veracyte is a direct peer in the breast-cancer predictive-diagnostic category and shares MeCo's model of leveraging centralized lab testing with reimbursement-driven commercialization.
• Biotheranostics: Biotheranostics commercializes the Breast Cancer Index, a gene-expression-based test used to guide extended endocrine therapy decisions in early-stage hormone-receptor-positive breast cancer. Biotheranostics is a tight direct peer in breast-cancer predictive biomarker commercialization with similar clinical evidence and reimbursement dynamics.

Emerging players

• Guardant Health: Guardant Health is a leading liquid-biopsy company developing blood-based oncology tests, including companion diagnostics. Guardant represents the emerging precision-oncology peer that competes for the same oncologist customer base and reimbursement real estate that MeCo would target.
• Natera: Natera is a molecular diagnostics company with a strong oncology franchise (Signatera MRD test) and a growing women's health business. Natera is comparable to MeCo as a peer developing tissue- and blood-based oncology tests run through centralized CLIA-certified labs targeting oncologist customers.
• Caris Life Sciences: Caris Life Sciences offers molecular profiling and AI-driven pathology tests that match cancer patients to therapies, including emerging companion-diagnostic applications. Caris is an emerging peer in the molecular companion-diagnostic space with a similar aspiration to monetize predictive biomarker-pharma pairings.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/meCo-diagnostics

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds3 records

Investors3 records

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 MeCo Diagnostics