Mammogen

What Mammogen does

Mammogen, Inc. is a privately held, female-led molecular diagnostics company founded in October 2020 within the IV BioHoldings (IVBH) ecosystem and headquartered in Newport Beach, California. The company develops RNA-powered liquid biopsy tests built on a proprietary dual-source cell-free RNA (cfRNA) platform that captures both tumor-associated and host-response signals to detect active biological processes in real time. Its lead product, genTRU-breast, is a blood-based clinical assay designed to support earlier breast cancer detection — particularly for the 38 million+ U.S. women with dense breast tissue, those with elevated risk, or those facing uncertainty about whether to escalate to advanced imaging such as MRI or contrast-enhanced mammography. Internal validation data reports up to 99% sensitivity and 89% specificity in Stage I disease, with reported 93%/97% and 97%/87% performance in women under 40 and over 55, respectively.

The company operates a sales-led, healthcare-provider-anchored go-to-market model. Tests are intended to be ordered by physicians (primary care, gynecologists, breast specialists) and processed through CLIA-certified laboratories under an exclusive strategic partnership with P4 Diagnostix, which provides seven certified labs, EHR integration, and commercialization infrastructure across the United States. Biomarker discovery is accelerated by the Emerge bio-analytics platform from Liquid Biosciences, which uses evolutionary computing to compress what historically takes 5–7 years into 22 days; Mammogen claims the IVBH portfolio has generated more than 200 novel RNA biomarkers. Revenue is intended to flow from per-test processing fees once commercialization commences, with management signaling a price point well below the $3,000 typical of legacy liquid biopsy assays.

Mammogen is pre-revenue and pre-commercial, currently advancing a prospective clinical trial to support CLIA-enabled market entry. The company has raised approximately $2 million in seed funding (June 2021) and up to $30 million in Series A financing (June 2026) led by a U.S. public retirement system, plus two small additional financings. Governance and clinical leadership have been deliberately upgraded ahead of commercialization, with Denise "DeeDee" DeMan (Founder/CEO of Bench International) appointed Chairwoman in June 2025 and Dr. Elise Berman (former CMO of Delphinus Medical Technologies) appointed Chief Medical Officer in June 2026. The platform is positioned as disease-agnostic, with a longer-term pipeline beyond breast cancer into other women's health, oncology, and metabolic indications.

Name

Mammogen

Legal name

Mammogen, Inc.

Website

https://mammogen.bio

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

1–10 employees

Short description

Mammogen is a female-led molecular diagnostics company developing RNA-powered blood-based liquid biopsy tests, led by the genTRU-breast assay for early breast cancer detection in women with dense breast tissue. It sells to healthcare providers via an exclusive lab partnership with P4 Diagnostix and is currently pre-commercial.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics / Breast Cancer Detection

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG)

akta.pro secondary industries

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes) (HLAAAMAH), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE)

Keywords

• Molecular diagnostics
• Breast cancer detection
• Liquid biopsy assay
• Cell-free RNA biomarkers
• Women's health diagnostics

Headquarters

HQ city

Aliso Viejo

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Diagnostic Testing Services: Blood-based clinical assay (genTRU-breast) sold to healthcare providers and patients through clinical laboratory partnerships. The test is ordered by physicians and performed in CLIA-certified laboratories. Revenue generated from test processing fees.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Mammogen develops and is commercializing the genTRU-breast™ blood-based clinical assay, a cell-free RNA (cfRNA) liquid biopsy test designed to support earlier breast cancer detection in women with dense breast tissue, elevated risk, or screening uncertainty. The assay runs on the broader genTRU™ liquid biopsy platform, which uses a proprietary dual-source cfRNA approach and AI/ML-driven biomarker discovery (via the Emerge platform from Liquid Biosciences) to capture both tumor-associated and host-response signals. Distribution is delivered through physician ordering and an exclusive clinical laboratory partnership with P4 Diagnostix, with the company advancing toward CLIA-enabled commercialization.

Product overview

Mammogen is a predictive health company developing RNA-powered molecular diagnostics. The company's flagship product is the genTRU-breast™ blood-based assay, part of the genTRU™ liquid biopsy platform. The platform uses cell-free RNA (cfRNA) analysis and a proprietary dual-source cfRNA™ approach to enable earlier breast cancer detection, designed to work alongside existing breast imaging pathways. The company also mentions a disease-agnostic discovery engine designed to identify novel cfRNA signatures for future diagnostic applications beyond breast cancer.

Differentiator

Problem solved

Functional benefit

Products and services

• genTRU-breast™ Blood-Based Assay A blood-based clinical assay that uses cell-free RNA (cfRNA) biomarkers and a dual-source approach capturing both tumor-associated and host-response signals to support earlier breast cancer detection, particularly in women with dense breast tissue, elevated risk, or uncertainty about escalating to MRI or contrast-enhanced mammography. Designed to be ordered by healthcare providers and processed through CLIA-certified laboratory partner P4 Diagnostix.

Quantifiable outcome

• Up to 99% sensitivity in Stage I breast cancer detection using real-time qPCR technology
• +4 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature4 records

Partnerships

Seven partnerships are on record, tiered core, flagship and minor.

• Denise 'DeeDee' DeMan / Bench InternationalcoreOthers · 30 June 2025DeeDee DeMan, founder/CEO of Bench International, appointed as Chairwoman of Mammogen's Board of Directors. Bench International is the longest-serving woman-founded executive search firm in life sciences with 50+ years of experience building leadership teams.
• BrilliantlycoreGTM or Marketing Partner · 15 October 2021Comprehensive collaboration between female-led women's health companies. Joint initiatives include a coffee table book about breast cancer journey, corrective exercise programs for survivors, and product giveaways (50 Brilliantly Warm wearable bra inserts). Partnership focuses on community engagement and patient empowerment beyond clinical products.
• P4 DiagnostixflagshipStrategic or Co-development Partner · 22 September 2021Exclusive strategic laboratory partnership for clinical assay development and validation. P4 Diagnostix provides seven CLIA-certified labs, EHR integration capabilities, and 20 years of diagnostic commercialization expertise. Partnership covers all clinical development and validation of genTRU-breast liquid biopsy platform across the commercialization pathway.
• IV BioHoldings (IVBH)flagshipOthersMammogen was founded within the IVBH ecosystem, a bio innovation studio applying advanced computation to biomarker discovery. IVBH provides capital, shared resources, and strategic partnerships across portfolio companies (LiquidLung, HepGene, Mammogen). Partnership with Liquid Biosciences provides AI/ML platform for biomarker discovery.
• Liquid BiosciencescoreTechnology or IntegrationProvides the Emerge bio-analytics platform using evolutionary computing and AI/machine learning for biomarker discovery. Platform analyzes millions of clinical datapoints and generates algorithms that evolve through natural selection to identify optimal biomarker sets.
• Touch, The Black Breast Cancer AllianceminorGTM or Marketing PartnerDr. Monique Gary, founder of Touch, partnered with The Breasties and Mammogen to oversee distribution of Brilliantly Warm products to diverse women in the breast cancer community.
• The BreastiesminorGTM or Marketing PartnerBreast cancer survivor/previvor organization partnering with Touch and Mammogen to distribute products and support community initiatives.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• GRAIL: GRAIL's Galleri is a blood-based multi-cancer early detection test, the most direct liquid biopsy competitor to Mammogen's genTRU-breast. Both target asymptomatic/early-stage cancer detection via a single blood draw, competing for the same screening-adjacent clinical workflows and reimbursement pathways.
• Guardant Health: Guardant Health offers blood-based oncology tests (Guardant360, Reveal for MRD) using cfDNA and is expanding into early detection. Both companies compete in liquid biopsy oncology diagnostics targeting similar oncologist and screening populations.
• Caris Life Sciences: Caris offers MI Profile and molecular profiling across tumor types using both DNA and RNA (whole transcriptome) approaches. Both companies are advancing RNA-inclusive multi-modal liquid biopsy diagnostics in oncology.

Broad incumbents

• Myriad Genetics: Myriad's BRACAnalysis and riskScore target hereditary breast/ovarian cancer risk assessment, and the CEO of Mammogen previously led commercial operations there. Both companies address breast cancer risk and detection through molecular diagnostics sold via physician channels.
• NeoGenomics: NeoGenomics provides oncology-focused clinical laboratory services including molecular diagnostics and liquid biopsy assays. Both companies serve oncologists and breast cancer specialists through CLIA-certified lab channels.
• Natera: Natera's Signatera (tumor-informed MRD) and Empower (hereditary cancer) operate in adjacent liquid biopsy oncology diagnostics. While focused on MRD rather than screening, both companies sell molecular diagnostic tests through clinical lab channels targeting oncologists.
• Hologic: Hologic's breast health franchise (Genius 3D mammography, Brevera) is the dominant breast imaging workflow that Mammogen's genTRU-breast is designed to integrate alongside. Both target the same radiology and breast imaging specialists.
• Bio-Techne: Bio-Techne acquired ExosomeDx (Mammogen CEO's former employer) and operates in the liquid biopsy / exosome diagnostics space. Both companies are pursuing RNA-based cancer detection through CLIA labs and physician channels.
• Exact Sciences: Exact Sciences (Cologuard, Oncotype DX, Thrive Earlier Detection acquisition) is an established cancer diagnostics leader with deep commercial, payer, and lab infrastructure that Mammogen must eventually compete against in early-detection screening.

Emerging players

• Delphinus Medical Technologies: Delphinus developed the FDA-cleared SoftVue breast imaging platform for dense breast tissue. Mammogen's newly appointed CMO was previously CMO at Delphinus, and both companies target the same under-screened dense-breast population with complementary diagnostic approaches.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds4 records

Investors

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 Mammogen