Exosome Diagnostics, Inc.

The General Hospital Corporation

Mikkel Noerholm

Johan Karl Olov Skog

Daniel Enderle

Xandra O Breakefield

Leileata M Russo

Bob Carter

Johan Skog

Wayne Comper

Charlotte Romain

Susan Belzer

Tai-Fen Wei

Emily Berghoff

Haoheng Yan

Aparna Ramachandran

Leonora Balaj

Georg Stoll

Johan Karl Skog

The present disclosure provides compositions, methods and kits for internal controls of microvesicle isolations. The compositions, methods and kits can comprise enveloped viruses, including, but not limited to, inactive mouse hepatitis virus (MHV).

Compositions and methods for internal controls of microvesicle isolations

The present invention features a method and kit for isolating microvesicles or extracting microvesicle nucleic acids from a biological sample by using a control particle. The present invention provides control particles that are viruses or virus-like particles, such as bacteriophages, that contain control nucleic acids that can be detected to assess the accuracy, reliability, and efficiency of the microvesicle isolation or nucleic acid extraction steps. The methods described herein may further comprise the analysis of the presence, absence, or level of at least one biomarker associated with a disease or medical condition for diagnosing, prognosing, or monitoring the disease or medical condition.

Controls for nucleic acid assays

The invention concerns gene signatures obtained from microvesicles and a method of applying these gene signatures in helping to determine a biological condition. The determination of a biological condition may aid, for example, the diagnosis, prognosis, and therapy treatment selection for disease in a subject.

Use of microvesicles in analyzing nucleic acid profiles

The invention provides novel methods and kits for isolating nucleic acids from biological samples, including cell-free DNA and/or cell-free DNA and nucleic acids including at least RNA from microvesicles, and for extracting nucleic acids from the microvesicles and/or from the biological samples.

Methods for isolating microvesicles and extracting nucleic acids from biological samples

The invention provides novel methods and kits for fully automated high-throughput method for isolation of extracellular vesicles and co-isolation of cell-free DNA from biofluids, including cell-free DNA and/or cell-free DNA and nucleic acids including at least RNA from microvesicles, novel methods and kits for isolation of extracellular vesicles and co-isolation of cell-free DNA from biofluids, including cell-free DNA and/or cell-free DNA and nucleic acids including at least RNA from microvesicles that do not require the use of phenol or chloroform, and for extracting nucleic acids from the extracellular vesicles and/or from the biological samples.

Automated and manual methods for isolation of extracellular vesicles and co-isolation of cell-free DNA from biofluids

Disclosed herein are methods for assaying a biological sample from a subject by analyzing components of microvesicle fractions in aid of risk, diagnosis, prognosis or monitoring of, or directing treatment of the subject for, a disease or other medical condition in the subject. Also disclosed are methods of treatment and identifying biomarkers using a microvesicle fraction of a subject. Kits, pharmaceutical compositions, and profiles related to the methods are also disclosed.

Cancer-related biological materials in microvesicles

The present invention relates generally to the field of biomarker analysis, particularly determining gene expression signatures from urine samples. The disclosure provides compositions, kits and methods for diagnosing a prostate disorder such as prostate cancer in a male subject.

Growing community of inventors

Gauting, Germany

Mikkel Noerholm