Loading organizations...
§ Private Profile · Alameda, CA, USA
Singulex is a technology company.
Singulex has raised $137.5M across 7 funding rounds.
Key people at Singulex.
Singulex was founded in 1997 by Herbert Fisk Johnson (Founder).
Singulex has raised $137.5M in total across 7 funding rounds.
Singulex is revolutionizing immunodiagnostics to transform healthcare with its Sgx Clarity® system, powered by Single Molecule Counting technology.
Key people at Singulex.
Singulex has raised $137.5M across 7 funding rounds. Most recently, it raised $40.0M Debt in September 2013.
| Date | Round | Lead Investors | Other Investors | Status |
|---|---|---|---|---|
| Sep 26, 2013 | $40M Debt Financing | Oxford Finance, Silicon Valley Bank | — | Announced |
| Jun 1, 2013 | $15M Series G | — | Dimension Capital, OrbiMed, Polaris Partners, Section 32 | Announced |
| Mar 1, 2012 | $15M Series F | — | Dimension Capital, OrbiMed, Polaris Partners, Section 32 | Announced |
| Jan 14, 2009 | $19M Venture Round | Jafco Ventures | Fisk Ventures, OrbiMed, Advantage Capital, Prolog Ventures | Announced |
| Jan 1, 2009 | $19M Series E | Jafco Ventures | Dimension Capital, OrbiMed, Polaris Partners, Section 32, Fisk Ventures | Announced |
| Jun 1, 2007 | $19M Series D | OrbiMed | Dimension Capital, Polaris Partners, Section 32, Advantage Capital, Fisk Ventures, Prolog Ventures | Announced |
| Sep 20, 2006 | $10.5M Debt Financing | — | Bridge Bank, Fisk Ventures, GE Capital, Prolog Ventures | Announced |
Singulex was founded in 1997 by Herbert Fisk Johnson (Founder).
Singulex has raised $137.5M in total across 7 funding rounds.
Singulex's investors include Oxford Finance, Silicon Valley Bank, Dimension Capital, OrbiMed, Polaris Partners, Section 32, Jafco Ventures, Fisk Ventures, Advantage Capital, Prolog Ventures, Bridge Bank, GE Capital.
Singulex is a commercial-stage biotechnology company specializing in next-generation immunodiagnostics (NGI) powered by its proprietary Single Molecule Counting (SMC) technology, which delivers up to 1000 times greater sensitivity than conventional immunoassays for precise biomarker measurement.[1][2][3] The company develops the Singulex Clarity system, a fully automated in vitro diagnostics platform, along with assays for cardiovascular, oncology, infectious, inflammatory, neurodegenerative, and autoimmune diseases; it serves clinicians, physicians, patients, pharmaceutical R&D labs, CROs, and academic institutions through lab testing services (over 3 million tests on 780,000+ patients), research-use-only Erenna systems, and clinical diagnostics.[1][2][3][5] Singulex addresses the problem of undetectable low-abundance biomarkers (e.g., cardiac troponin I, cytokines at femtogram/mL levels), enabling proactive health management, earlier disease detection, reduced healthcare costs, and accelerated therapeutic discovery over reactive treatment.[1][2][3]
Growth momentum includes CE marking for the Clarity system and assays in 2017 (commercially available in Europe), a 2017 FDA 510(k) submission for U.S. clearance (anticipated 2018 commercialization), and ongoing development of point-of-care platforms and expanded assays.[1][2][4]
Singulex emerged as a pioneer in single-molecule detection technology, founded to commercialize SMC for clinical diagnostics and research, though exact founding year and founders' names are not detailed in available sources.[1][3] Leadership includes experienced executives like John (prior roles at Chiron Diagnostics, Bayer, Baxter, with 60+ publications, 15 patents, and SBIR grants), Jeff (Ph.D. in Bioengineering from UC San Diego), and Mr. Vogt (25 years at Mallinckrodt, Chemical Engineering degrees).[1] The idea stemmed from advancing immunoassay sensitivity to detect previously undetectable biomarkers in complex samples without protein stripping, fueling biomarker validation for drug safety/efficacy and diseases like cardiovascular, Alzheimer's, oncology, and diabetes.[3][5]
Early traction involved launching research-use-only Erenna Immunoassay Systems for pharma/academia, building a U.S.-based clinical lab (3M+ tests), and securing CE marks in 2017, with FDA submission marking a pivotal shift to automated clinical platforms.[2][3][4]
Singulex rides the wave of precision medicine and biomarker-driven diagnostics, where ultra-sensitive detection shifts healthcare from reactive treatment to proactive management amid rising chronic disease burdens (e.g., cardiovascular, oncology).[1][2][3] Timing aligns with regulatory progress (2017 CE marks, FDA submission) and demand for high-sensitivity troponin tests, as studies validate SMC's role in identifying coronary artery disease severity in stable patients.[6] Market forces like aging populations, cost pressures, and pharma's need for better R&D tools favor Singulex, influencing the ecosystem by enabling new therapeutic discoveries and influencing standards in immunodiagnostics.[3][5]
Singulex is poised for U.S. market entry post-FDA clearance, expanding Clarity assays and point-of-care platforms to global labs and beyond-clinical uses, potentially scaling tests exponentially.[1][2][4] Trends like AI-integrated diagnostics and personalized wellness (e.g., CVMedHome) will shape growth, amplifying its influence in transforming immunodiagnostics from niche research to mainstream healthcare disruption.[3][5] As biomarker precision becomes table stakes, Singulex's SMC edge positions it to redefine early detection, much like its foundational promise to "see what others can’t."[6]
