Freenome develops non-invasive blood tests for early cancer detection by combining genomics and proteomics to identify cancer signals in blood. The tests are sold to healthcare providers and research institutions and are also used in clinical trials and collaborations. The process involves analyzing a blood sample with proprietary algorithms to assess cancer risk and guide follow-up diagnostics. By integrating multiple data types and pursuing large-scale trials, Freenome aims to make early cancer screening routine and improve patient outcomes, with a focus on expanding colorectal cancer testing.
Company Size
201-500
Company Stage
IPO
Headquarters
Brisbane, California
Founded
2014
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AI-Powered Liquid Biopsy emerges as a high-stakes frontier in precision oncology, attracting hundreds of millions in venture and public funding. "BCC Research examines how AI is improving biomarker detection, ctDNA analysis, early cancer diagnosis and disease monitoring while advancing precision oncology and clinical decision-making." September 29, 2026 08:23 ET | Source: BCC Research LLC Boston, Sept. 29, 2026 (GLOBE NEWSWIRE) - Artificial intelligence is fundamentally reshaping the liquid biopsy landscape, transforming blood-based cancer diagnostics from a promising concept into a clinically deployable, commercially scalable precision oncology tool. BCC Research's latest analysis, AI Impact on Liquid Biopsy with Emphasis on Cancer Market - BCC Pulse Report, examines the accelerating convergence of AI, multiomics, and noninvasive diagnostics, mapping the investment flows, technological advances, and strategic partnerships defining this rapidly evolving space. Key Findings - Surging Investment Activity: AI-driven liquid biopsy platforms have attracted substantial capital across funding rounds and public programs. Freenome secured $254 million in 2024 - led by Roche - to advance its multiomics platform integrating cfDNA, protein, and RNA for multicancer detection. The European Investment Bank committed approximately $23 million to Universal DX in 2025, while ARPA-H selected Tempus AI for its ADAPT program targeting metastatic cancers using AI-driven biomarker and clinical trial design frameworks. - AI Adoption Concentrated in High-Value Use Cases: Current AI integration is most prominent in early cancer detection, biomarker discovery, and therapy monitoring - precisely those applications where complex multiomic data volumes exceed the analytical capacity of conventional methods and where diagnostic accuracy directly impacts patient outcomes. - Multiomics Integration as the Central Technical Driver: AI's capacity to simultaneously analyze cfDNA, RNA, protein, epigenetic, and fragmentomic data from a single blood draw is enabling multicancer detection from one sample - a capability that fundamentally expands the clinical addressability and commercial scope of liquid biopsy platforms. - Public-Sector Programs Accelerating Clinical Validation: Government funding is de-risking the clinical validation pipeline. ARPA-H's ADAPT initiative, NIH's Cancer Moonshot, and EU consortium programs such as BRECISE - which provided approximately $2.1 million to Novigenix AI in 2025 - are embedding AI-enabled liquid biopsy into real-world oncology workflows and regulatory pathways. - Emerging Technologies Deepening the Diagnostic Stack: Key technology frontiers include foundation models and deep learning for cfDNA methylation analysis, exosome-based biopsy combined with AI and Raman spectroscopy, infrared spectroscopy with PANOmics platforms, and paper-based AI liquid biopsy systems designed for resource-constrained settings. Freenome's 2026 collaboration with NVIDIA to develop an open-source cfDNA methylation foundation model signals growing infrastructure-level commitment to the space. - Competitive Landscape: Leading players include Guardant Health, GRAIL, Freenome, Natera, SOPHiA GENETICS, Illumina, Roche, QIAGEN, and Tempus AI, alongside emerging innovators such as OneCell Diagnostics, Dxcover, Oxford Cancer Analytics, Tvaster Genkalp, Universal DX, Novigenix AI, Gene Solutions, PanGIA Biotech, Zephyr AI, and M42. Strategic Implications Rising global cancer incidence, combined with strong clinician and patient preference for noninvasive testing, is generating sustained structural demand for AI-enhanced liquid biopsy platforms. Blood-based diagnostics that previously lacked clinical-grade sensitivity are being repositioned as viable alternatives to tissue biopsy - a shift enabled directly by AI's ability to extract signal from low-frequency tumor variants and complex biological noise in cfDNA and exosome data. Platform partnerships are accelerating this transition. Guardant Health's 2025 integration with Zephyr AI for multimodal biomarker discovery, Illumina's 2026 launch of Connected Multiomics, and Roche's deployment of a large-scale NVIDIA GPU-powered AI factory all reflect a broader infrastructure buildout that will lower the cost and time required to bring the next generation of diagnostics to clinical scale. Academic anchors including Johns Hopkins University and Stanford University are simultaneously advancing large-scale data modeling, reinforcing the scientific credibility underpinning commercial platforms. Investment Considerations The AI-driven liquid biopsy sector presents a differentiated investment opportunity at the intersection of oncology, diagnostics, and applied AI. Established players such as Roche, Illumina, and Natera - which launched proprietary AI foundation models in 2025 - are building scalable platform advantages, while well-capitalized startups such as Freenome and OneCell Diagnostics are positioned as both innovation drivers and acquisition targets. Investors should weigh meaningful near-term headwinds: regulatory approval timelines, GDPR-constrained data aggregation in Europe, limited reimbursement infrastructure in developing markets, and the biological complexity of isolating tumor-derived signals from exosomal noise. Nonetheless, the convergence of public funding mandates, VC conviction, and expanding clinical partnerships suggests that market leadership in this segment will be determined over the next three to five years - rewarding early, well-positioned capital. About the Report AI Impact on Liquid Biopsy with Emphasis on Cancer Market - BCC Pulse Report provides qualitative strategic analysis covering the AI technology landscape in liquid biopsy, investment and funding activity, key use case adoption, emerging technology assessment, competitive intelligence, and profiles of leading and emerging market participants. About BCC Research BCC Research provides objective, unbiased measurement and assessment of market opportunities with detailed market research reports. Our experienced industry analysts assess growth trends, identify and evaluate new and changing market opportunities, and provide critical information and innovative decision support tools to help inform the strategic decision-making process. For media inquiries, email [email protected] or visit our media page for access to our market research library. Any data and analysis extracted from this press release must be accompanied by a statement identifying BCC Research LLC as the source and publisher.
Jefferies initiated coverage of Freenome with a Buy rating and $17 price target on 17 August 2026, according to CNBC. The target implies a roughly 47% increase from the previous close of $11.56. Shares jumped more than 12% on the news. Freenome develops blood-based cancer screening tests. The company recently went public via a SPAC merger on 21 July 2026, raising more than $300 million. Its lead product, a colorectal cancer test, won FDA approval on 27 July 2026. Abbott Laboratories handles US commercialisation under a deal that included a $100 million milestone payment. Roche covers international markets and led a $254 million funding round in 2024. The company plans to expand into lung cancer screening and aims to cover more than ten cancer types over time.
FDA approves SimpleScreen blood test for CRC screening. SimpleScreen CRC has demonstrated a sensitivity of 81.1% for CRC detection. The FDA has approved SimpleScreen CRC (Freenome), a blood-based screening option for colorectal cancer (CRC), for adults 45 and older who are at average risk for the disease, with Abbott planning to commercialize the test this fall.[1] SimpleScreen CRC detects CRC-associated signals from cell-free DNA in the blood. In a prespecified analysis from the PREEMPT CRC study (NCT04369053) adjusted to match the US Census population distribution, the test demonstrated a sensitivity of 81.1% for CRC detection and 13.7% for advanced precancerous lesions (APLs), including 30.7% for APLs with high-grade dysplasia.[1] Specificity for advanced colorectal neoplasia was 90.4%.[1] In practical terms, the test correctly identified approximately 8 in 10 CRC cases and produced a negative result in 9 of 10 people without CRC or advanced precancerous lesions. The PREEMPT CRC data were published in JAMA in June 2025, where the primary analysis in 27,010 consecutively enrolled participants showed a CRC sensitivity of 79.2% (95% CI, 68.4%-86.9%; P = .006) and specificity for advanced colorectal neoplasia of 91.5% (95% CI, 91.2%-91.9%; P <.001), with all primary end points meeting prespecified acceptance criteria.[2] In adults aged 45 to 49 years, among whom only approximately 20% are current with recommended screening, the test showed 100% sensitivity for CRC and 94.8% specificity for advanced colorectal neoplasia.[2] Freenome is also developing an updated next-generation version. Data presented at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) showed that the updated test achieved 80.4% to 85% sensitivity for CRC and 18.2% to 22% sensitivity for APLs at 90% specificity, reflecting improved precancer detection over the approved first-generation version.[3] "The most effective screening test is the one a person will actually complete," Aasma Shaukat, MD, MPH, a professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on PREEMPT CRC, stated in a news release. "Many people who should be screened for colorectal cancer simply aren't. A blood-based test provides another way to reach unscreened patients, and bringing more people into the screening fold leads to earlier detection and better outcomes." About PREEMPT CRC and Clinical development. PREEMPT CRC enrolled more than 48,000 asymptomatic, average-risk adults aged 45 to 85 years at more than 200 sites across the United States who were scheduled for a routine screening colonoscopy, with colonoscopy findings serving as the reference standard.[1] The study used a hybrid recruitment strategy to broaden diversity, with more than 11% of participants identifying as Black or African American and more than 11% as Hispanic or Latino.[2] SimpleScreen CRC is indicated for adults 45 and older at average risk for CRC who have been referred by a health care provider. A positive result should be followed by a colonoscopy. The test is not a replacement for diagnostic or surveillance colonoscopy in high-risk individuals.[1] With FDA approval, SimpleScreen CRC meets Medicare coverage criteria and has been incorporated into the updated American Cancer Society guidelines for CRC screening.[1] "The fact is that 90% of colorectal cancer deaths are preventable, yet the disease will still claim more than 55,000 lives in the US this year alone," Anjee Davis, MPAA, CEO of Fight Colorectal Cancer, stated in the news release.[1] "Regular screening is the key to reversing that trend, and new, minimally invasive screening options that help more people get screened are a critical part of that process. Colorectal cancer is increasingly affecting younger adults, and a screening test that fits into a routine visit, accompanied by prompt follow-up in response to an abnormal result, can play an important role in driving earlier treatment and prevention." References. 1. FDA approves Freenome's SimpleScreen CRC blood-based screening test; Abbott to commercialize in the U.S. News release. Freenome. July 27, 2026. Accessed July 27, 2026. 2. Shaukat A, Burke CA, Chan AT, et al. Clinical validation of a circulating tumor DNA-based blood test to screen for colorectal cancer. JAMA. 2025;334(1):56-63. doi:10.1001/jama.2025.7515.
– Freenome common stock expected to begin trading on the Nasdaq Capital Market under the ticker symbol “FRNM” on July […]
The FDA has approved Freenome's SimpleScreen CRC, a blood-based colorectal cancer screening test. Abbott will exclusively market the test in the US starting this autumn, adding it to its portfolio alongside the Cologuard stool test acquired through its $21 billion purchase of Exact Sciences earlier this year. SimpleScreen will compete with Guardant Health's Shield blood test, approved in 2024. Both tests target adults aged 45 and older at average risk, addressing approximately 60 million Americans overdue for recommended screening. The approval follows Freenome's PREEMPT CRC study of over 48,000 people, which showed the test detected about 80% of colorectal cancers. Freenome will receive a $100 million milestone payment from Abbott under their August 2025 commercial agreement.