What Freenome does

Freenome is a clinical-stage biotechnology company developing blood-based multi-cancer screening tests built on a proprietary AI-powered multiomics platform. Founded in 2014 and headquartered in Brisbane, California (formerly South San Francisco), the company combines cell-free DNA (cfDNA), methylation, cell-free RNA (cfRNA), and protein biomarker assays with proprietary deep learning and machine learning classifiers to detect cancer at its earliest, most treatable stages from a standard blood draw. Freenome operates a CLIA-certified high-complexity clinical laboratory that executes its screening assays, and its platform architecture processes both tumor- and immune-derived signatures jointly rather than relying on a single analyte.

The company's flagship product is SimpleScreen CRC, a blood-based colorectal cancer screening test that completed its FDA Premarket Approval submission and was included in the American Cancer Society's updated CRC screening guideline (May 2026), with FDA approval anticipated in H2 2026. Updated clinical data showed 85% sensitivity for CRC and 22% sensitivity for advanced precancerous lesions at 90% specificity in a 966-sample study, with a 2.6-fold reduction in limit of detection versus the prior version. The pipeline also includes SimpleScreen Lung (investigational, with reported 90.7% sensitivity at 50% specificity, advancing through the PROACT LUNG registrational study targeting 20,000 participants) and a broader multi-cancer platform validated through the Vallania, Sanderson, and PREEMPT CRC studies. The Health System Solution pairs SimpleScreen testing with EHR-integrated digital health tools that automate patient identification, education, and adherence workflows for health system customers.

Freenome's commercial model is structured primarily through licensing partnerships rather than direct-to-consumer sales. Exact Sciences (now Abbott) holds exclusive U.S. commercialization rights in a deal valued up to $885 million tied to regulatory and guideline milestones, and Roche holds exclusive ex-U.S. rights in a deal valued over $200 million including a $75 million equity investment. The company also runs a direct B2B "founding partner" program with health systems and conducts biopharma biomarker collaborations. Freenome has raised approximately $1.5 billion cumulatively across multiple venture rounds and strategic Roche investments, and is pursuing a public listing via SPAC business combination with Perceptive Capital Solutions Corp (announced December 2025, S-4 declared effective June 2026, closing anticipated July 2026) to be renamed Freenome, Inc. and listed on Nasdaq under ticker FRNM.

Name

Freenome

Legal name

Freenome Holdings, Inc.

Website

https://freenome.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

251–500 employees

Short description

Freenome is a clinical-stage biotechnology company developing AI-powered blood-based multi-cancer screening tests combining cfDNA, methylation, and protein biomarkers with deep learning for early cancer detection, serving U.S. and international health systems via licensing partnerships with Exact Sciences and Roche.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics

NAICS

Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Proteomics & Biomarker Analytical Testing (HLAGADAG)

Keywords

• Blood-based cancer detection
• Multiomics screening platform
• Cell-free DNA diagnostics
• Early cancer detection tests
• Liquid biopsy diagnostics

Headquarters

HQ city

South San Francisco

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. U.S. Licensing & Commercialization (Exact Sciences): Exclusive U.S. licensing and commercialization rights granted to Exact Sciences for the blood-based colorectal cancer screening test, with deal value up to $885 million tied to regulatory and screening-guideline milestones; contingent on FDA approval (expected H2 2026).
2. Ex-U.S. Licensing & Kitted Test Commercialization (Roche): Exclusive agreement with Roche to develop and commercialize 'kitted' versions of Freenome's cancer screening assays outside the U.S., with deal potentially worth over $200 million including a $75 million equity investment, R&D support, and access to Roche's SBX sequencing technology.
3. U.S. Broad Commercialization (Abbott, forthcoming): Abbott (formerly Exact Sciences) will lead broad U.S. commercialization of SimpleScreen CRC blood-based test following expected FDA approval anticipated mid-2026.
4. Health System Direct Sales (Founding Partner Program): Direct B2B sales of cancer-specific blood-based screening (SimpleScreen CRC and lung) combined with EHR-integrated digital health tools to health system 'founding partners,' supported by a full implementation team; recurring per-test / per-program economics implied.
5. Biopharma Biomarker / R&D Collaborations: Research and biomarker development collaborations with pharmaceutical companies (e.g., ADC Therapeutics) using Freenome's multiomics platform for patient stratification and drug development; financial terms typically not disclosed.

Go-to-market motion1 record

Core offering

Freenome fundamentally develops and sells blood-based cancer screening tests built on its proprietary multiomics platform, which integrates cell-free DNA, methylation, cell-free RNA, and protein biomarker assays with advanced computational biology and machine learning to detect cancer at its earliest stages from a standard blood draw. Its lead product, SimpleScreen CRC, is a colorectal cancer screening test currently under FDA Premarket Approval review, complemented by investigational SimpleScreen Lung and an integrated Health System Solution that pairs the tests with EHR-integrated digital health tools. Revenue flows through milestone-based licensing deals with Exact Sciences (now Abbott) in the U.S. and Roche internationally, direct sales to health system founding partners, and biopharma research collaborations.

Product overview

Freenome offers an AI-powered multiomics platform for early cancer detection delivered as a unified set of blood-based screening tests and integrated health system offerings. The company's core technology is the Freenome Multiomics Platform, which integrates cell-free DNA, methylation, cell-free RNA, and protein biomarker assays with proprietary deep learning and machine learning classifiers. Built on this platform, the SimpleScreen product line comprises cancer-specific blood-based screening tests, led by SimpleScreen CRC (the flagship colorectal cancer screening test, currently under FDA Premarket Approval review) and SimpleScreen Lung (an investigational lung cancer screening test in development). These tests are delivered to providers through the Freenome Health System Solution, which pairs SimpleScreen testing with EHR-integrated digital health tools to automate patient identification, education, and adherence support. Together, the Multiomics Platform, the SimpleScreen test family, and the Health System Solution form a vertically integrated offering that combines laboratory science, AI software, and clinical workflow tooling.

Differentiator

Problem solved

Functional benefit

Brands

• SimpleScreen: Freenome's blood-based cancer screening test product line, including SimpleScreen CRC (colorectal cancer blood test under FDA review).
• PREEMPT CRC

Products and services

• SimpleScreen CRC Freenome's flagship blood-based colorectal cancer (CRC) screening test built on its multiomics platform, currently under FDA Premarket Approval review with anticipated approval in the second half of 2026. The updated version demonstrated 85% sensitivity for CRC and 22% sensitivity for advanced precancerous lesions at 90% specificity in a 966-sample validation study presented at ASCO GI 2026; the earlier PREEMPT CRC pivotal study reported 79.2% CRC sensitivity and 91.5% specificity for non-advanced colorectal neoplasia. Intended for average-risk adults aged 45-85 as a non-invasive screening alternative to colonoscopy.
• SimpleScreen Lung Investigational blood-based multiomics screening test for the early detection of lung cancer in high-risk individuals, with reported sensitivities of 90.7% at 50% specificity and 80.4% at 75% specificity across various lung cancer subtypes and all stages. Being advanced through the PROACT LUNG registrational study targeting 20,000 high-risk participants.
• Freenome Health System Solution An end-to-end solution pairing SimpleScreen blood-based testing (for colorectal and lung cancers) with EHR-integrated digital health tools that automate patient identification, education, and adherence support using native EHR functionality to close screening gaps and streamline workflows. Offered to founding partner health systems with implementation support, co-development publication opportunities, and early access to additional cancer tests.
• Freenome Multiomics Biomarker Collaboration Service Research and biomarker development collaborations with pharmaceutical companies using Freenome's multiomics platform for patient stratification and drug development support, including identification of patients likely to respond to specific therapeutics (e.g., ADC Therapeutics' ADCT-402 for diffuse large B-cell lymphoma).

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability6 records

Feature5 records

Recent moves7 records

Expansion highlights7 records

Direct peers

• Guardant Health: Direct competitor in blood-based cancer screening and liquid biopsy. Guardant's Shield test is already FDA-approved for CRC screening, directly competing with Freenome's SimpleScreen CRC, and both companies use cfDNA-based approaches with advanced computational biology for early cancer detection.
• GRAIL: Direct peer in multi-cancer early detection via blood-based screening. GRAIL's Galleri test targets multi-cancer detection from a single blood draw, overlapping directly with Freenome's long-term multi-cancer roadmap (Vallania and Sanderson studies).
• Exact Sciences: Both a commercial partner (U.S. licensee for SimpleScreen CRC) and a competitor via Cologuard, the established non-invasive CRC screening stool test. Comparable as a cancer screening franchise with strong commercial infrastructure and a focus on early detection.
• Natera: Peer in blood-based oncology diagnostics. Natera's Signatera is a leading tumor-informed MRD test, and its oncology franchise (previously led by Freenome's CSO Jimmy Lin) competes in adjacent liquid biopsy applications and shares a similar cfDNA-based technology foundation.

Emerging players

• Delfi Diagnostics: Emerging liquid biopsy company using cfDNA fragmentation patterns for cancer detection, with a comparable machine learning / deep learning approach. Rob Guigley, Freenome's CCO, was previously CCO at Delfi, indicating overlapping expertise and adjacent technology positioning.
• Thrive Earlier Detection (Exact Sciences subsidiary): Acquired by Exact Sciences, Thrive developed blood-based multi-cancer screening tests (CancerSEEK). It represents an emerging player in the same multi-cancer early-detection space Freenome targets with its Vallania and Sanderson programs.

Broad incumbents

• Adaptive Biotechnologies: Broader diagnostics incumbent using immune-sequencing approaches (T-cell receptor profiling). Sally Howard, Freenome's SVP Regulatory, was previously VP Regulatory at Adaptive, indicating shared talent pool and overlapping regulatory pathways in novel diagnostic assays.
• NeoGenomics: Established oncology diagnostics company with broad oncology testing services. Douglas VanOort, Freenome's board member, is the former Chairman and CEO of NeoGenomics, reflecting shared strategic perspectives on the oncology diagnostics market.
• Roche Diagnostics: Broad diagnostics incumbent and Freenome's ex-U.S. commercial partner. Roche provides global infrastructure, SBX sequencing technology access, and is a strategic equity holder with board representation, while also being a broad competitor in cancer diagnostics.
• Quest Diagnostics: Broad clinical laboratory incumbent and Series E investor in Freenome. Quest offers extensive cancer screening and diagnostic services infrastructure that could complement or compete with Freenome's lab-developed and FDA-approved tests.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

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Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Subsidiaries1 record

Funding overview

Funding rounds15 records

Investors56 records

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M&A1 record

Investments

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

Frequently asked questions about Freenome