Freenome
Documentation ProvidedRegulatory Status Disclosed
Overview
Freenome is a medical AI tool that utilizes a multiomics platform and artificial intelligence to develop blood-based tests for early cancer detection. The platform analyzes various biomarkers, including cell-free DNA (cfDNA), cfRNA, and proteins, to identify complex biological signals associated with cancer. Freenome’s approach aims to detect cancer in its earliest, most treatable stages through a standard blood draw.
- What it does: Freenome develops blood tests for early cancer detection by combining multiomics technology with AI and machine learning to analyze molecular patterns in blood samples. Their platform identifies cancer-specific signals, including DNA methylation patterns.
- Who it is for: The tool is designed for healthcare providers in various care settings, including primary care and health systems, to aid in cancer screening. Its initial focus includes colorectal cancer screening for average-risk adults aged 45 and older. Freenome is also developing tests for other indications, such as lung cancer.
- How it fits a clinical or practice workflow: Freenome’s blood-based tests are intended to integrate into routine clinical workflows, offering a less invasive screening option. The company plans to provide digital tools that assist healthcare systems in identifying eligible patients, engaging care teams, and incorporating screening into standard care.
- Notable capabilities: A notable capability is the SimpleScreen™ CRC, a blood-based test for colorectal cancer screening that has received FDA approval. This test utilizes AI/ML-based models to detect specific methylation signatures in cfDNA. Freenome’s platform is also being advanced to develop next-generation assays and automation technologies, integrating new analytes and leveraging deep learning models to potentially improve detection and expand across cancer indications.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Early cancer detection
- Blood-based screening tests
- Multiomics technology
- Artificial intelligence and machine learning
- Personalized Cancer Detection approach
- SimpleScreenu2122 CRC for Colorectal Cancer Screening
- CLIA certified laboratory
Use Cases
- Early detection of colorectal cancer
- Expanding access to cancer screening
- Personalized cancer risk assessment
What Physicians Need to Know
Evidence Base
Freenome's approach combines a multiomics platform that analyzes genomic, epigenomic, and proteomic biomarkers with artificial intelligence and machine learning to detect cancer-specific signals in the bloodstream. Their colorectal cancer (CRC) screening test, SimpleScreenu2122 CRC, applies an AI/ML-based model to detect specific methylation signatures in cell-free DNA (cfDNA). The company's research program focuses on the discovery, development, and validation of early cancer detection tests.
Clinical Validation Studies
Freenome has conducted large-scale clinical validation studies, most notably the PREEMPT CRCu00ae Study, which is the largest clinical study validating a blood-based colorectal screening test. This prospective, multi-center observational study enrolled over 40,000 participants across more than 200 study sites. The updated SimpleScreenu2122 CRC test met all primary and secondary endpoints in a pivotal clinical validation study. The updated test demonstrated 80.4% sensitivity for detecting CRC, including 52% of Stage I cases, and 18.2% sensitivity for advanced precancerous lesions (APLs), with 41.9% sensitivity for APLs with high-grade dysplasia (HGD). The specificity for no findings on colonoscopy was 90%. Freenome is also conducting the PROACT LUNG Study for lung cancer screening and the Vallania Study for multiple cancer types.
Alert Fatigue Management
Freenome's platform leverages AI and machine learning, which can be instrumental in managing alert fatigue by filtering, correlating, and prioritizing alerts effectively. While not explicitly detailed for Freenome, general strategies for alert fatigue management in healthcare include eliminating inconsequential alerts, tiering alerts by severity, and continuously reviewing and adjusting the alert system.
Drug Interaction Checking
The provided information does not indicate that Freenome's tools include drug interaction checking capabilities. Freenome focuses on early cancer detection through blood-based tests. Drug interaction checkers are typically separate tools that scan medication lists for potential conflicts, often powered by FDA drug label data.
Differential Diagnosis Support
Freenome's primary focus is on early cancer detection through blood-based screening tests, rather than providing differential diagnosis support across a broad range of conditions. Their Personalized Cancer Detection approach aims to match blood-based screening tests to cancers most relevant to individuals based on their health profile.
Guideline Update Frequency
Freenome's SimpleScreenu2122 CRC blood test has been included in the American Cancer Society (ACS) Guideline for Colorectal Cancer Screening. The ACS guideline update recognized blood-based testing as an option and reviewed clinical performance and modeling data, including Freenome's test. Freenome continues to develop updated versions of its tests and conducts independent clinical validation studies, with an updated version of SimpleScreen CRC expected to complete in Q3 2026.
Clinical Workflow Integration
Freenome's blood-based tests are designed for integration into routine clinical workflows with a standard blood draw. They offer EHR-native digital tools to help health systems identify eligible patients, engage patients and care teams, and integrate screening into routine care. Freenome aims to support population-health workflows and care-pathway optimization through multiomic testing combined with real-world clinical data and EMR integration.
Decision Audit Trail
The provided information does not specifically mention a 'decision audit trail' feature for Freenome's clinical decision support tools. However, their use of AI/ML and population-scale testing to build molecular and clinical datasets suggests a data-driven approach that could support such a feature.
Physician Tip
Freenome's SimpleScreenu2122 CRC offers a convenient blood-based screening option for average-risk adults aged 45 and older, which can help reach patients who may decline or not complete other recommended screening methods. A positive result from SimpleScreenu2122 CRC indicates a signal that may suggest colorectal cancer or advanced precancerous lesions and *must* be followed by a colonoscopy. It is crucial to inform patients about the pros and cons of all screening options and the limitations of blood-based testing. SimpleScreenu2122 CRC is not a replacement for diagnostic or surveillance colonoscopy in high-risk individuals.
Freenome's health system solution includes EHR-native digital tools for identifying eligible patients, engaging care teams, and integrating screening into routine care. They also provide population health and EMR integration services. Freenome has commercial collaboration agreements with Abbott for the U.S. market and Roche for markets outside the U.S., which will facilitate the commercialization and integration of their tests into broader healthcare systems. These partnerships aim to combine Freenome's blood-based screening tests with clinical workflow and patient navigation capabilities.
Details
| Category | Clinical Decision Support & Reference, Lab & Diagnostics |
| Pricing | Unknown — unknown |
| Mobile App | No |
| API Available | No |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Cleared AI-estimated Freenome's SimpleScreen™ CRC is approved by the U.S. Food and Drug Administration (FDA) for Colorectal Cancer Screening in adults 45 and older who are at average risk for the disease. The FDA has also granted Breakthrough Device Designation to SimpleScreen™ Lung, Freenome's investigational lung cancer screening test. |
| Integrations | |
| EHR | Not specified |
| Specialties | Family Medicine, Gastroenterology, Internal Medicine, Oncology |
Social Proof
| Customers | unknown |
| Notable | Abbott (commercialization partner for SimpleScreen CRC in the U.S.)Roche (strategic collaboration for ex-U.S. commercialization and technology development)Siemens HealthineersMerck KGaAMorehouse School of MedicineOracle CernerElligo Health ResearchNVIDIA. |
What the Web Says
Freenome is a biotechnology company focused on developing blood-based tests for early cancer detection, particularly colorectal cancer, using multiomics and AI. Their SimpleScreen CRC test aims to provide a convenient and accessible screening option, potentially increasing adherence compared to traditional methods like colonoscopies or stool tests. While their technology shows promise in detecting early-stage cancers and precancerous lesions, some analysts have noted that its sensitivity for advanced adenomas is lower than stool-based tests like Cologuard.
Overall: MixedStrengths
- Convenient blood-based screening for early cancer detection.
- Potential to increase screening adherence due to ease of use.
- Utilizes advanced multiomics and AI for comprehensive analysis.
- Strong investor backing from notable companies like Roche and Google.
- Improved sensitivity in updated test for precancerous lesions and colorectal cancer.
- Collaboration with Abbott for commercialization upon FDA approval.
Limitations
- Sensitivity for advanced adenomas is lower than some stool-based tests.
- Currently a clinical-stage, pre-revenue company without a commercially approved product (as of late 2022).
- Path to profitability is uncertain due to competition and high R&D costs.
- FDA approval for the first-generation test is expected mid-2026, with a supplemental application for the next-generation test.
- Some employee reviews mention poor management despite smart people and a good mission.
- Widespread commercial use may face barriers with USPSTF approval.
Based on reviews from: Nanalyze, MedTech Dive, BioPharma Dive, Freenome (Official Website), SimplyHired, Zippia, Comparably, Bain Capital Life Sciences, BioSpace, PR Newswire, YouTube
Last updated: 2026-08-30
Ratings & Reviews
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Press & Coverage
Freenome Newsroom
FDA Grants Breakthrough Device Designation to Freenome's Blood-Based SimpleScreenu2122 Lung Cancer Screening Test
Freenome announced that the FDA has granted Breakthrough Device Designation to its investigational SimpleScreenu2122 Lung cancer screening test for high-risk adults. This designation aims to accelerate the development and review of the blood-based test, which utilizes multiomics and AI/ML.
2026-08
Freenome Newsroom
FDA Approves Freenome's SimpleScreenu2122 CRC Blood-Based Screening Test; Abbott to Commercialize in the U.S.
The FDA has approved Freenome's SimpleScreenu2122 CRC, a blood-based test for colorectal cancer screening in average-risk adults aged 45 and older. Abbott will exclusively commercialize the test in the U.S., and Freenome will receive a $100 million milestone payment from Abbott.
2026-07
Freenome Newsroom
Freenome Debuts as a Publicly Traded Company Focused on Blood-Based Early Cancer Detection
Freenome announced the closing of its business combination with Perceptive Capital Solutions Corp., making it a publicly traded company on the Nasdaq Capital Market under the ticker symbol u201cFRNMu201d. The transaction generated approximately $310 million in gross proceeds to support its cancer screening portfolio and AI/ML-enabled multiomics platform.
2026-07
Freenome Newsroom
Freenome Reports Top-Line Readout of Updated SimpleScreenu2122 CRC Colorectal Cancer Screening Blood Test Met All Primary and Secondary Endpoints
Freenome reported favorable results from its pivotal clinical validation study for an updated version of the SimpleScreenu2122 CRC blood test, meeting all primary and secondary endpoints. The updated test showed improved sensitivity for advanced precancerous lesions and colorectal cancer.
2026-07
GenomeWeb
TD Cowen Initiates Coverage of Freenome With Buy Rating
TD Cowen initiated coverage on Freenome Inc. with a Buy rating and a price target of $17.00, citing the company's position as a first mover in liquid biopsy colorectal cancer screening and its differentiated liquid biopsy chemistry and partnerships.
2026-08
Freenome Newsroom
Freenome Announces Exclusive Agreement with Roche to Expand Technology Collaboration and Develop and Commercialize Cancer Screening Tests Outside the U.S.
Freenome and Roche expanded their technology collaboration with an exclusive agreement to develop and commercialize cancer screening tests outside the U.S., focusing on 'kitted' tests for accelerated access through a decentralized model.
2025-11
Freenome Newsroom
Freenome Announces JAMA Publication of Data from Pivotal Study of its Blood-Based Test for Colorectal Cancer
Freenome announced the publication of detailed results from its pivotal PREEMPT CRC study in JAMA, highlighting findings from the largest prospective study of a blood-based screening test for colorectal cancer.
2025-06
Freenome Newsroom
Freenome Raises $254 Million in New Funding to Accelerate its Platform for Early Cancer Detection
Freenome secured $254 million in new funding, led by Roche, to accelerate its platform for early cancer detection. The funds will be used to advance clinical programs and expand platform capabilities.
2024-02
Frequently Asked Questions
Freenome's technology utilizes a multiomics platform that combines computational biology, machine learning, and various data types to detect subtle cues of cancer in its earliest stages through a simple blood draw. Its primary clinical use is for early cancer detection, with the first FDA-approved test, SimpleScreenu2122 CRC, specifically for colorectal cancer screening in average-risk adults aged 45 and older.
Freenome's SimpleScreenu2122 CRC blood test for colorectal cancer screening received FDA approval on July 27, 2026. Freenome's Clinical Laboratory is also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for high complexity clinical testing. Additionally, SimpleScreenu2122 Lung, an investigational lung cancer screening test, has been granted Breakthrough Device Designation by the FDA.
Freenome aims to integrate its blood-based screening tests into routine clinical workflows, leveraging a simple blood draw and its software platform. The company is also partnering with healthcare organizations to optimize clinical and EHR workflows and provide digital tools. By offering an accessible screening option, Freenome intends to help increase screening adherence rates and provide earlier detection insights.
While Freenome's SimpleScreen CRC test has shown good sensitivity for colorectal cancer, its sensitivity for detecting advanced precancerous lesions is lower compared to some stool-based tests like Cologuard. A positive non-invasive test result, including Freenome's, should always be followed by a diagnostic colonoscopy. The U.S. Preventive Services Task Force (USPSTF) approval for blood-based tests is also noted as a potential barrier to widespread commercial use due to the newer paradigm and potentially weaker performance for advanced adenomas compared to established methods.
Alternatives to Freenome's blood-based colorectal cancer screening test include established methods such as colonoscopy (considered the gold standard), CT colonography (virtual colonoscopy), flexible sigmoidoscopy, and stool-based tests like the fecal immunochemical test (FIT) and Cologuard. Other companies developing similar blood-based cancer screening tests include Exact Sciences (which will commercialize Freenome's CRC test), Guardant Health, and GRAIL.
With FDA approval, Freenome's SimpleScreen CRC test meets the coverage criteria for Medicare. Abbott will exclusively commercialize the test in the U.S. Specific pricing details for physicians were not immediately available, but the FDA approval and anticipated inclusion in American Cancer Society guidelines are expected to support broader access.
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| Last Verified: 2026-08-31 | First Added: 2026-08-30
Investors who backed Freenome
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