Exosome Diagnostics, Inc.

The General Hospital Corporation

The Brigham and Women's Hospital, Inc.

Johan Karl Olov Skog

Mikkel Noerholm

Leileata M Russo

Xandra O Breakefield

Daniel Enderle

Wayne Comper

Casey Maguire

Bob Carter

Robert Kitchen

Vasisht Tadigotla

Jamil Azzi

Charlotte Romain

Aparna Ramachandran

Haoheng Yan

Emily Berghoff

Tai-Fen Wei

Susan Belzer

Wei Yu

Dennis Brown

Christine Coticchia

Leonora Balaj

James Hurley

Dominik Grimm

Elena Castellanos-Rizaldos

Georg Stoll

Mia Sher

Xuan Zhang

Erez Eitan

Seth Yu

Kevin Miranda

Leileata Russo

Kevin C Miranda

Lori LoGuidice

A method for extracting nucleic acids from a biological sample by isolating nucleic acid-containing particles from the biological sample by one or more centrifugation procedures, performing one or more steps to mitigate adverse factors that prevent or might prevent high quality nucleic acid extraction, and extracting nucleic acids from the isolated particles. The centrifugation procedures are performed at a speed not exceeding about 200,000 g. The extracted nucleic acids contain both 18S and 28S rRNA.

Method for isolation of nucleic acid containing particles and extraction of nucleic acids therefrom

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 relates generally to a process for isolating subpopulations of EVs to identify biomarkers useful identifying, determining the progression of, and/or prognosing a disease, including a neurological disease. More particularly, the present invention relates to detection technology of various exosomal biomarkers including proteins, protein modifications, sugars, RNA, DNA, lipids, and metabolites, and combinations thereof.

Treatment and diagnosis of parkinson's disease using isolated and enriched populations of biofluid-derived extracellular vesicles

The invention relates generally to the use of microvesicle biomarkers such as nucleic acids, including nucleic acid signatures, and/or proteins for assessing a kidney transplant rejection in a patient. The invention further relates to assessing, and/or to monitoring kidney transplant rejection in patients who have received a renal transplant.

Methods of detecting renal transplant rejection using microvesicle nucleic acid biomarkers

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 present invention relates generally to methods and kits for detecting one or more biomarkers, such as an Epidermal Growth Factor Receptor (EGFR) mutation, e.g., T790M mutation, L858R mutation, one or more exon19 insertions and/or one or more exon19 deletions in the EGFR gene, in a biological sample to aid in diagnosis, prognosis, monitoring, or therapy selection for a disease such as, for example, cancer. The methods and kits are useful in aiding in diagnosis, prognosis, monitoring, or therapy selection for lung cancer, e.g., non-small cell lung cancer (NSCLC).

Methods and compositions to detect mutations in plasma using exosomal RNA and cell free DNA from non-small cell lung cancer patients

Methods for extracting high quality nucleic acids from a heterogenous collection of nucleic acid-containing materials from a biological sample are disclosed. The heterogenous collection of nucleic-acid containing materials may contain cells or microvesicles, or both. The extractions obtained by the methods described herein are characterized by high yield and high integrity, making the extracted nucleic acids useful for various applications in which high quality nucleic acid extractions are preferred, e.g., a diagnosis, prognosis, or therapy evaluation for a medical condition.

Nucleic acid extraction from heterogeneous biological materials

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 relates generally to the use of microvesicle RNA signatures for diagnosis, predicting, and/or to monitor treatment efficacy, including patients who are candidates for renal transplant and/or who have received a renal transplant.

Profiling microvesicle nucleic acids and uses thereof as signatures in diagnosis of renal transplant rejection

Microvesicles are small membrane vesicles that either shed or bud off eukarotic cells. Analysis of the nucleic acid content of microvesicles may be useful in detecting the presence or absence of genetic aberrations. This invention discloses novel methods of diagnosing, prognosing, monitoring, or treating a disease, such as cancer, or other medical condition in a subject involving analyzing one or more nucleic acids contained within an isolated microvesicle for the presence or absence of one or more Kras genetic aberrations.

Use of microvesicles in analyzing mutations

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.

Growing community of inventors

Lincoln, MA, United States of America

Johan Karl Olov Skog