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§ Private Profile · 266 Second Ave, Suite 200, Waltham, MA 02451
Diagnostics company developing non-invasive cancer tests using exosomes from body fluids, avoiding traditional biopsies.
Founded in 2008 by Sheldon Hirshon and Johan Skog, Exosome Diagnostics is a Waltham, Massachusetts enterprise that develops non-invasive diagnostic tests detecting various cancers using exosomes isolated from body fluids like urine. The company leverages small cellular vesicles containing nucleic acids to enable disease detection without traditional biopsies, primarily through its flagship urine-based ExoDx Prostate test. Beyond prostate cancer, this technology targets pathologies including bladder, kidney, breast, and glioblastoma cancers, supported by an intellectual property portfolio of approximately 200 filed patents. The business also secured strategic partnerships with Qiagen, Mount Sinai Medical Center, and the Michael J Fox Foundation to advance its oncology research and point-of-care instrumentation development. In June 2018, Bio-Techne acquired Exosome Diagnostics for $250 million in cash and up to $325 million in contingent milestone payments, reaching a total potential valuation of $575 million.
Exosome Diagnostics has raised $111.0M across 5 funding rounds.
Exosome Diagnostics has raised $111.0M in total across 5 funding rounds.
Exosome Diagnostics is a diagnostics company specializing in non-invasive, exosome-based liquid biopsy tests for cancer detection and monitoring, primarily targeting prostate cancer. Its flagship product, the ExoDx Prostate (IntelliScore or EPI), is a urine-based test that predicts high-grade prostate cancer risk, helping patients and physicians avoid unnecessary biopsies; it serves urologists, oncologists, and patients while addressing the problem of overdiagnosis in prostate cancer screening.[1][2][4][5] The company also provides biopharma services for biomarker discovery using exosomal RNA, cell-free DNA, and proteins, and has pursued companion diagnostics (CDx) collaborations with pharmaceutical firms; it was acquired by Bio-Techne in 2018 but divested to Mdxhealth in August 2025, retaining its CLIA-certified labs in the US and Europe for continued growth in urology diagnostics.[2][4]
Exosome Diagnostics emerged from pioneering research on exosomes—microvesicles released by cells into biofluids like urine and blood, carrying intact nucleic acids and proteins for molecular analysis. The company commercialized its proprietary Exo-Lution™ platform for minimally invasive diagnostics in personalized medicine, with early focus on cancer markers; its European arm in Martinsried, Germany, handles ISO 13485-certified IVD products.[1][2] Key figures include Mikkel Noerholm, PhD, MBA, as Head of European Operations; it gained traction with the ExoDx Prostate test, the world's first exosome-based clinical diagnostic, now included in 2019 NCCN Guidelines and soon as CE-IVD in Europe.[2] Investor Forbion backed it as a "realised" portfolio company, reflecting successful commercialization before Bio-Techne's 2018 acquisition and the 2025 divestiture to Mdxhealth.[1][4]
Exosome Diagnostics rides the liquid biopsy wave in precision oncology, shifting from invasive tissue biopsies to biofluid analysis amid rising demand for personalized medicine and early cancer detection. Timing aligns with NCCN guideline adoption and regulatory progress (e.g., CE-IVD), fueled by market forces like prostate cancer prevalence and biopsy avoidance to cut healthcare costs.[2][4] It influences the ecosystem by pioneering exosome tech—validating extracellular vesicles for diagnostics—and enabling pharma CDx, now amplified by Mdxhealth's urology portfolio for broader clinician adoption.[1][2][4]
Under Mdxhealth, Exosome Diagnostics will likely expand ExoDx Prostate adoption in urology, integrating with genetic/epigenetic tests for comprehensive cancer risk profiling. Trends like AI-enhanced biomarker analysis and exosome drug delivery could extend its platform beyond diagnostics. Its influence may grow by standardizing non-invasive monitoring, reducing overtreatment, and partnering deeper in oncology—building on its trailblazing liquid biopsy foundation to shape accessible precision medicine.[4]
Exosome Diagnostics has raised $111.0M across 5 funding rounds. Most recently, it raised $30.0M Series C in July 2017.
| Date | Round | Lead Investors | Other Investors | Status |
|---|---|---|---|---|
| Jul 1, 2017 | $30M Series C | Forbion, Tiger Infrastructure Partners | Arcus Ventures, Blue Ridge Capital, Btov Partners, CD Venture, NGN Capital | Announced |
| Jan 1, 2016 | $16M Series B | — | Arcus Ventures, Forbion, Blue Ridge Capital, CD Venture, NGN Capital, QIAGEN, Tiger Management | Announced |
| Sep 1, 2015 | $18M Series B | — | Arcus Ventures, Forbion, CD Venture, NGN Capital, Tiger Management | Announced |
| Mar 1, 2014 | $27M Series B | Arcus Ventures, QIAGEN | Forbion | Announced |
| May 1, 2010 | $20M Series A | Forbion, NGN Capital | — | Announced |
Exosome Diagnostics has raised $111.0M in total across 5 funding rounds.
Exosome Diagnostics's investors include Forbion, Tiger Infrastructure Partners, Arcus Ventures, Blue Ridge Capital, btov Partners, CD-Venture, NGN Capital, QIAGEN, Tiger Management.