A recently published study confirms the reliability and specificity of the ExoRNeasy Maxi kit by Qiagen, Hilden, Germany, for extracting RNA from exosomes and other extracellular vesicles found in human serum and plasma.1 The ExoRNeasy Maxi kit is one of several Qiagen initiatives aimed at developing sample technology solutions for noninvasive liquid biopsies.

Extracellular RNA can carry genomic information throughout the body, and is emerging among the key candidates for biomarker development. Such molecular tests are beginning to be used for the diagnosis and monitoring of cancer and other diseases, using fluids such as blood or serum as an alternative to tissue samples.


Markus Sprenger-Haussels, PhD, Qiagen.

According to Qiagen sources, the ExoRNeasy Maxi kit offers a fast and reliable way to isolate RNA from exosomes, delivering high-quality results with less labor-intensive sample preparation. Developed in partnership with Exosome Diagnostics Inc, Cambridge, Mass, the company’s standardized protocol is “the most sophisticated method for the extraction of RNA from exosomes,” says Markus Sprenger-Haussels, PhD, senior director and head of Qiagen’s sample technologies unit for the life sciences, and coauthor of the recent study.

“The study also reinforces Qiagen’s leadership for sample technologies which are paving the way for the growing acceptance of liquid biopsies,” says Sprenger-Haussels. “Qiagen provides a range of novel sample technologies for liquid biopsies to help gain valuable molecular insights from easily collected samples of blood or other liquids.”

Exosomes are tiny enclosures that circulate in blood and other body fluids, carrying genomic information, including RNA, mRNAs, and miRNAs. In 2013 Qiagen and Exosome Diagnostics established a partnership to develop and commercialize high-performance sample preparation kits for processing such molecules. In 2014 Qiagen began launching the first standardized sample kits for exosome research, including the ExoRNeasy Maxi kit for larger samples (up to 4 ml), the ExoRNeasy Midi kit for smaller samples (1 ml or less), and the ExoEasy Maxi kit for isolation of intact exosomes and other extracellular vesicles.

Qiagen’s portfolio of solutions for preanalytical processing of molecular biomarkers from blood and other fluids can support a variety of analytical targets for researchers, including:

  • Cell-free, circulating nucleic acids (cfDNA).
  • Circulating tumor cells (CTCs).
  • Exosomes and other extracellular vesicles.

Johan Skog, PhD, Exosome Diagnostics.

“Qiagen’s partnership with Exosome Diagnostics is accelerating the pace at which researchers and drug developers across the globe are utilizing exosomes from biofluids,” says Johan Skog, PhD, chief scientific officer at Exosome Diagnostics. “Our ongoing collaboration with Qiagen and these important new data provide further validation that Exosome Diagnostics’ technology offers a highly sensitive and reproducible method to isolate and extract nucleic acid from exosomes for routine laboratory use.”

Qiagen is actively partnering with pharmaceutical and biotech companies to develop companion diagnostics using liquid biopsies for stratification or monitoring of patients. In January 2015, Qiagen announced the CE-IVD marking of its Therascreen EGFR RGQ plasma PCR kit, the first regulated companion diagnostic assay based on analysis of molecular biomarkers from circulating tumor DNA (ctDNA). The kit detects a range of EGFR mutations in plasma, when a tumor sample is not evaluable for a patient, to guide the use of Iressa in the treatment of non-small cell lung cancer (NSCLC).


  1. Enderle D, Spiel A, Coticchia CM, et al. Characterization of RNA from exosomes and other extracellular vesicles isolated by a novel spin column-based method. PLoS One. 2015;10(8):e0136133; doi: 10.1371/journal.pone.0136133. Published online August 28, 2015.