• Exosome Diagnostics GmbH
  • Am Klopferspitz 19a
  • 82152 Planegg/Martinsried
  • Germany
  • moc.xdemosoxe@ofni

Mikkel Noerholm, PhD, MBA
Head of European Operations

About Exosome Diagnostics

Exosome Diagnostics is developing and commercializing revolutionary biofluid-based diagnostics for use in personalized medicine and collaborates with pharma companies to develop sophisticated companion diagnostics (CDx). Exosomes are messengers released by all living cells into biofluids such as blood, urine and cerebrospinal fluid and provide a stable source of cell-specific intact nucleic acids and proteins. The company’s novel exosome-based technology platform, Exo-Lution™, can yield comprehensive and dynamic molecular insights to transform how cancer and other serious diseases are detected, diagnosed, treated and monitored. The European subsidiary at the IZB in Martinsried develops and commercializes in-vitro diagnostic products under ISO 13485.

What is your motivation?

A big motivator for us is working with cutting-edge science and translating it to tangible diagnostic products that make a difference to patients and doctors in everyday clinical care. Exosome Diagnostics’ test, ExoDx Prostate IntelliScore (EPI), is the first diagnostic test in clinical practice in the world to use exosomes and extracellular vesicle biomarkers. It is indicated for patients under suspicion of prostate cancer, with a PSA in the gray zone (2–10 ng/mL), to aid in the decision whether to proceed with a biopsy. The test is available in the US as a laboratory developed test and is currently being developed by the Exosome Diagnostics’ European subsidiary at the IZB as an in-vitro diagnostic (IVD) for the European market and to benefit European patients and clinicians.

“The IZB has been crucial for setting up our local operations in 2010 and has supported throughout our path to successful acquisition and beyond.”

Mikkel Noerholm, PhD, MBA
Head of European Operations

Exosome Diagnostics is developing and commercializing biofluid-based diagnostic tests using proprietary technology platforms. The company also offers biopharma services for exploration of exosomal RNA, cell-free DNA, and proteins to identify and validate biomarkers without tissue samples. The urine-based ExoDx™ Prostate test is included in the 2019 NCCN Guidelines for initial and repeat biopsy and will soon be offered as CE-IVD in Europe. The company has clinical laboratories in Waltham (US) and Munich (DE) was acquired by Bio-Techne in 2018.