{ "id": "epjnnwg4ay", "slug": "singlera-genomics", "title": "Singlera Genomics (鹍远生物)", "updated": "2026-10-11", "topic_path": [ { "id": "society", "label": "Society and history", "api_url": "https://www.edgepedia.org/api/v1/topics/society" }, { "id": "society.economy", "label": "Economics and business", "api_url": "https://www.edgepedia.org/api/v1/topics/society.economy" }, { "id": "society.economy.business", "label": "Business and work", "api_url": "https://www.edgepedia.org/api/v1/topics/society.economy.business" }, { "id": "society.economy.business.business_overview", "label": "Business and work overview", "api_url": "https://www.edgepedia.org/api/v1/topics/society.economy.business.business_overview" }, { "id": "society.economy.business.companies_corporations", "label": "Companies and corporations", "api_url": "https://www.edgepedia.org/api/v1/topics/society.economy.business.companies_corporations" }, { "id": "society.economy.business.companies_corporations.startups", "label": 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"label": "Diagnostics and genomics companies", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.us.t2021.society.economy.business.companies_corporations.startups.health_biotech.diagnostics-and-genomics-companies" } ] } ], "excerpt": "Singlera Genomics (鹍远生物) is a cancer early-detection company co-founded in 2014 in San Diego, California, with operations in La Jolla and Shanghai, developing ctDNA methylation screening tests.", "snippet": "Singlera Genomics (鹍远生物) is a cancer early-detection company co-founded in 2014 in San Diego, California, with operations in La Jolla and Shanghai, developing ctDNA methylation screening tests.", "node": "society.economy.business.companies_corporations.startups.health_biotech.diagnostics-and-genomics-companies.cancer-and-molecular-diagnostics", "markdown": "# Singlera Genomics (鹍远生物)\n\nSinglera Genomics (鹍远生物) is a cancer early-detection company that, according to the company, was co-founded in July 2014 in San Diego, California, and develops non-invasive molecular diagnostics built on circulating tumor DNA (ctDNA) methylation testing, with R&D centers and business operations in [La Jolla](https://www.edgepedia.org/la-jolla), California, and [Shanghai](https://www.edgepedia.org/shanghai), China.[1](https://www.prnewswire.com/news-releases/singlera-genomics-raises-150-million-in-series-b-financing-to-promote-the-development-and-commercialization-of-early-cancer-screening-products-301192505.html) Independent reporting describes it as founded in 2014 and focused on next-generation genetic testing and molecular diagnostics.[2](https://m.36kr.com/p/1774571243223298) Chinese filings and press record it as 江苏鹍远生物科技股份有限公司 (Jiangsu Singlera Biotechnology) in 2024, while earlier coverage used 上海鹍远生物科技股份有限公司 (Shanghai Singlera Biotechnology); the registered entity and place of registration differ between reports.[3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml) • [2](https://m.36kr.com/p/1774571243223298) The company remains privately held and operating as of mid-2026, with its latest confirmed financing in July 2024.\n\n| Item | Detail |\n| --- | --- |\n| Founded | 2014; the company states July 2014, San Diego, California[1](https://www.prnewswire.com/news-releases/singlera-genomics-raises-150-million-in-series-b-financing-to-promote-the-development-and-commercialization-of-early-cancer-screening-products-301192505.html) • [2](https://m.36kr.com/p/1774571243223298) |\n| Bases | La Jolla (R&D) and Shanghai per the company; a Jiangsu-registered entity appears in 2024 reports[1](https://www.prnewswire.com/news-releases/singlera-genomics-raises-150-million-in-series-b-financing-to-promote-the-development-and-commercialization-of-early-cancer-screening-products-301192505.html) • [3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml) |\n| Sector | IVD / cancer early screening via DNA methylation[4](https://www.singlera.com.cn/new/791.html) |\n| Reported rounds | RMB 120M (2016); RMB 350M (2018); USD 150M / ~RMB 1bn (2020); RMB 300M (2022); >RMB 100M (2024)[3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml) • [1](https://www.prnewswire.com/news-releases/singlera-genomics-raises-150-million-in-series-b-financing-to-promote-the-development-and-commercialization-of-early-cancer-screening-products-301192505.html) • [2](https://m.36kr.com/p/1774571243223298) |\n| Key investors | CICC Kai Tak fund, Lilly Asia Ventures, Fengshi Capital, Songhe Capital, Detong Capital, Sansure Biotech[3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml) • [1](https://www.prnewswire.com/news-releases/singlera-genomics-raises-150-million-in-series-b-financing-to-promote-the-development-and-commercialization-of-early-cancer-screening-products-301192505.html) • [2](https://m.36kr.com/p/1774571243223298) |\n| Regulatory marks | NMPA Class III registration for ColonAiQ (May 2024); FDA Breakthrough Device designation for PDACatch (May 2023)[3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml) |\n| Status (2026) | Privately held, operating; Ping An Health partnership announced July 2026[4](https://www.singlera.com.cn/new/791.html) |\n\n## History and origins\n\nThe company states it was co-founded in July 2014 in San Diego, California, and maintains R&D centers and business operations in La Jolla, California, and Shanghai.[1](https://www.prnewswire.com/news-releases/singlera-genomics-raises-150-million-in-series-b-financing-to-promote-the-development-and-commercialization-of-early-cancer-screening-products-301192505.html) Independent reporting dates the founding to 2014.[2](https://m.36kr.com/p/1774571243223298)\n\nIn November 2021 Singlera launched the \"Fusheng Plan\" (福声计划), a Chinese pan-cancer early-screening study run with [Fudan University](https://www.edgepedia.org/fudan-university) and 11 top-tier (Grade IIIA) hospitals, expected to enroll more than 60,000 participants across 10 provinces, and municipalities in east, north, southwest, and southern China.[2](https://m.36kr.com/p/1774571243223298)\n\n## Products, technology and clinical evidence\n\nSinglera builds all of its products on DNA-methylation-based molecular testing and states it operates three technology platforms: MONOD (high-throughput methylation sequencing), mTitan (specific biomarker detection), and mGuard (multiplex PCR).[4](https://www.singlera.com.cn/new/791.html) Products include **PanSeer**, a multi-cancer ctDNA methylation (chemical tags on DNA from tumor cells circulating in blood) screen developed with Fudan University; **ColonAiQ** (常艾克), a blood test for colorectal cancer; **GutSeer**, a digestive-tract multi-cancer platform; and **PDACatch**, a pancreatic cancer early-detection test.[1](https://www.prnewswire.com/news-releases/singlera-genomics-raises-150-million-in-series-b-financing-to-promote-the-development-and-commercialization-of-early-cancer-screening-products-301192505.html) • [3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml) • [5](https://www.singlera.com.cn/new/799.html)\n\n**Published validation** spans several studies. The 2020 PanSeer paper in [Nature Communications](https://www.edgepedia.org/nature-communications) analyzed plasma from the Taizhou Longitudinal Study, in which 123,115 healthy subjects provided samples for long-term storage and were monitored for cancer. PanSeer detected five common cancers in 88% (95% CI 80–93%) of post-diagnosis patients at 96% specificity (95% CI 93–98%).[6](https://pubmed.ncbi.nlm.nih.gov/32694610/) The company-funded PreC real-world study used ColonAiQ as the primary screening method for 105,285 community participants aged 40–80 recruited between January 2021 and December 2022; 6,759 (6.42%) tested positive, and 48.56% of positives underwent follow-up colonoscopy.[7](https://doi.org/10.1016/j.annonc.2023.09.1775) The GUIDE study of GutSeer for digestive-tract pan-cancer detection, published in Molecular Cancer in 2025, reached a validation-cohort AUC of 0.950, with 82.8% sensitivity and 95.8% specificity.[5](https://www.singlera.com.cn/new/799.html) A multicenter GutSeer validation reported at the American Society of Clinical Oncology in 2024 found sensitivity ranging from 64.7% at stage I to 96.3% at stage IV, and tissue-of-origin accuracy of 79.0% in one cohort (individual cancers 71.7% to 94.7%).[8](https://doi.org/10.1200/jco.2024.42.3_suppl.739)\n\nCompany-stated performance figures are higher for some products: ColonAiQ is described as having 87.3% sensitivity and 91.1% specificity.[4](https://www.singlera.com.cn/new/791.html) Separately, at the 2025 International Liver Cancer Association congress, Fudan Zhongshan Hospital presented traceHCC, a tumor-agnostic ctDNA methylation model built on Singlera's GutSeer platform for hepatocellular carcinoma recurrence monitoring, trained on 342 HCC patients and 1,415 normal controls at 99% specificity; preoperative ctDNA methylation status was an independent prognostic factor for recurrence-free survival (HR = 6.33).[5](https://www.singlera.com.cn/new/799.html)\n\n## Funding by the numbers\n\nReported rounds total well over RMB 1.7 billion. In August 2016 the company raised RMB 120 million in Series A financing led by Lilly Asia Ventures.[3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml) In March 2018 it raised RMB 350 million in a Series A+ led by Songhe Capital (松禾资本) and Jingxu Capital.[3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml) On December 15, 2020, the company announced a USD 150 million Series B led by the CICC Kai Tak Innovative Biomedicine Fund and co-led by Detong Capital and Furong Investment; Chinese-language reporting describes the same round as nearly RMB 1 billion.[1](https://www.prnewswire.com/news-releases/singlera-genomics-raises-150-million-in-series-b-financing-to-promote-the-development-and-commercialization-of-early-cancer-screening-products-301192505.html) • [3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml) In June 2022 it completed a RMB 300 million Series B+ led by Fengshi Capital (沣石资本), with Galaxy Yuanhui, Guojing Investment, Junci Investment, Qiandao Investment, Baishide, a Huachen Meijing fund, and strategic investor [Sansure Biotech](https://www.edgepedia.org/sansure-biotech) participating.[2](https://m.36kr.com/p/1774571243223298) On July 5, 2024, the company announced a strategic financing of over RMB 100 million from a consortium of Yangzhou state-owned investors including Yangzhou Guojin Group, Yangzhou Dingyi, Longchuan Holding, Guangling Guotou, and Jingkai Investment.[3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml)\n\n## Regulatory approvals and commercial traction\n\nIn May 2024 ColonAiQ, a kit testing methylation of the Septin9, BCAT1, IKZF1, BCAN, and VAV3 genes by PCR fluorescence probe method, received Class III medical device registration from China's National Medical Products Administration (NMPA).[3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml) In May 2023 PDACatch received US FDA Breakthrough Device designation and has been launched as a [laboratory-developed test](https://www.edgepedia.org/laboratory-developed-test) (LDT) service in the US through third-party labs.[3](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml)\n\nOn distribution, the PreC study demonstrates screening at community scale, with 105,285 participants tested over two years and colonoscopy compliance among positives of 48.56%.[7](https://doi.org/10.1016/j.annonc.2023.09.1775) On July 28, 2026, Singlera joined Ping An Health's Health Longevity Ecosystem Alliance as a strategic \"precision screening\" partner; the company says prior cooperation with Ping An Health has covered hundreds of thousands of tumor early-detection cases, a figure not independently verified.[4](https://www.singlera.com.cn/new/791.html)\n\n## Position among Chinese early-screening peers\n\nChinese cancer early screening has drawn both dedicated listed companies and oncology-gene-testing firms. New Horizon Health (诺辉健康) listed in Hong Kong, and the two oncology gene-testing companies Burning Rock (燃石医学) and Genetron (泛生子) have both entered early screening.[2](https://m.36kr.com/p/1774571243223298) Singlera's stated differentiation is its focus on ctDNA methylation technology and pan-cancer screening.[2](https://m.36kr.com/p/1774571243223298) Singlera remains private while its main early-screening peer, New Horizon Health, is listed.\n\n## References\n\n1. [Singlera Genomics raises $150 million in Series B financing (PRNewswire, Dec 15 2020)](https://www.prnewswire.com/news-releases/singlera-genomics-raises-150-million-in-series-b-financing-to-promote-the-development-and-commercialization-of-early-cancer-screening-products-301192505.html)\n2. [36氪首发 | 「鹍远生物」获3亿元B+轮融资 (36Kr, June 2022)](https://m.36kr.com/p/1774571243223298)\n3. [鹍远生物获过亿元战略投资，加速推动癌症早筛商业化进程 (中新网, 2024-07-05)](https://www.chinanews.com.cn/cj/2024/07-05/10246273.shtml)\n4. [鹍远生物携手平安健康，共启精准筛查新篇章 (company press release, July 2026)](https://www.singlera.com.cn/new/791.html)\n5. [鹍远生物联合中山医院开发肝癌MRD新技术 (company press release, 2025)](https://www.singlera.com.cn/new/799.html)\n6. [Non-invasive early detection of cancer four years before conventional diagnosis using a blood test (Nature Communications, 2020)](https://pubmed.ncbi.nlm.nih.gov/32694610/)\n7. [584P Two-year update of the prospective evaluation of ColonAiQ (PreC) study (Annals of Oncology, 2023)](https://doi.org/10.1016/j.annonc.2023.09.1775)\n8. [Multicenter clinical validation of GutSeer (JCO 2024)](https://doi.org/10.1200/jco.2024.42.3_suppl.739)\n9. [Cancer Screening Companies Are Rapidly Proliferating: Are They Ready for Business? (Cancer Epidemiology, Biomarkers & Prevention)](https://doi.org/10.1158/1055-9965.epi-22-0102)\n\n\n---\n*Topic: Encyclopedia › Society and history › Economics and business › Business and work › Business and work overview › Companies and corporations › Venture-backed startups and growth companies › Health, biotech, and medtech startups › Diagnostics and genomics companies › Cancer and molecular diagnostics*\n\n*Initially written Sep 17, 2026 · Reviewed: Sep 20, 2026 · Edited: Sep 20, 2026; Oct 11, 2026 · Last review: Sep 20, 2026*\n\n*Copyright 2026 EdgeChat AI, a subsidiary of Biostate AI.*\n\nLicense: Edgepedia Community License 1.0, https://www.edgepedia.org/edgepedia/license\n", "same_as": [], "url": "https://www.edgepedia.org/singlera-genomics", "markdown_url": "https://www.edgepedia.org/singlera-genomics.md", "license": { "name": "Edgepedia Community License 1.0", "url": "https://www.edgepedia.org/edgepedia/license", "summary": "Free with credit, commercial use included. AI training is open to everyone. For other uses, organizations over USD 100M in revenue or 100M monthly users license separately.", "spdx": "LicenseRef-Edgepedia-Community-1.0" }, "credit": "\"Singlera Genomics (鹍远生物)\", Edgepedia (EdgeChat), https://www.edgepedia.org/singlera-genomics. Edgepedia Community License 1.0.", "credit_md": "\"[Singlera Genomics (鹍远生物)](https://www.edgepedia.org/singlera-genomics)\", Edgepedia (EdgeChat), [https://www.edgepedia.org/singlera-genomics](https://www.edgepedia.org/singlera-genomics). [Edgepedia Community License 1.0](https://www.edgepedia.org/edgepedia/license).", "credit_html": "\"Singlera Genomics (鹍远生物)\", Edgepedia (EdgeChat), https://www.edgepedia.org/singlera-genomics. Edgepedia Community License 1.0.", "speakable": "Singlera Genomics is a cancer early-detection company co-founded in 2014 in San Diego, California, with operations in La Jolla and Shanghai, developing ctDNA methylation screening tests." }