Company Overview of Exosome Diagnostics, Inc.
Exosome Diagnostics, Inc. develops and commercializes biofluid-based diagnostics to deliver personalized precision healthcare that improves lives. The company develops exosome-based diagnostics technology platform that harvests comprehensive and dynamic molecular information contained within exosomes from various fresh or frozen biofluids to deliver personalized healthcare to guide treatment decisions and in real-time along the entire patient care continuum. Its technology combines RNA analysis with DNA and protein analysis to deliver comprehensive and dynamic molecular insights to transform how cancer and other serious diseases are detected, diagnosed, treated, and monitored. The company al...
Riverside Technology Center
840 Memorial Drive
Cambridge, MA 02139
Founded in 2008
Key Executives for Exosome Diagnostics, Inc.
Chief Executive Officer and Director
Chief Science Officer and Founding Scientist
Vice President of Business Development
Compensation as of Fiscal Year 2015.
Exosome Diagnostics, Inc. Key Developments
Exosome Diagnostics, Inc. Announces Data Demonstrating ExoIntelliScore Prostate Accurately Predicted Gleason Score
Oct 1 15
Exosome Diagnostics, Inc. presented new positive data from a clinical study for the company's novel, urine-based prostate cancer liquid biopsy, ExoIntelliScore Prostate (formally referred to as Exo106). The data demonstrated that ExoIntelliScore Prostate accurately predicted in pre-radical prostatectomy (RP) urine samples of patients with prostate cancer, objective clinical features present in RP specimens and also provided initial improved discrimination of RP Gleason Score 4+3, a subset of patients at elevated risk for aggressive disease. These results add to a growing body of clinical validation evidence that show ExoIntelliScore Prostate's unique ability to accurately and completely non-invasively identify high-grade prostate cancer. They also suggest the potential for the first-in-class genetic-based assay to be utilized throughout the diagnostic paradigm, including prior to initial biopsy, as well as for sequential monitoring of disease progression in patients enrolled in active surveillance. The data were presented at a poster session entitled, A non-invasive urine exosome gene expression assay accurately predicts pathologic stage and grade in the prostatectomy specimen at the 18thEuropean Cancer Congress (ECCO) 40thEuropean Society for Medical Oncology (ESMO) Annual Meeting in Vienna, Austria (September 25-29, 2015). The current diagnostic landscape for prostate cancer is imprecise, setting off a cascade of events that starts with unnecessary and inaccurate biopsies, and leads to over-diagnosis and over-treatment of the disease with radical treatment choices including prostatectomies. This assay's ability to give urologists a more precise, genetically informed understanding of a man's risk for aggressive disease via a simple urine sample, without the need for an invasive prostate tissue biopsy could help prevent that cascade.
Exosome Diagnostics, Inc. Announces Data Demonstrating Ability of its Exosomal RNA Technology Platform
Sep 29 15
Exosome Diagnostics, Inc. announced data demonstrating the ability of its exosomal RNA (exoRNA) technology platform to predict early response to immunotherapy treatment two to four weeks after treatment initiation, based on mRNA expression changes, and to serially and longitudinally monitor the response in patients with malignant melanoma. In the study, exosomal RNA (exoRNA) was isolated from the plasma of 16 patients with malignant melanoma before and after receiving immunotherapy treatment with Ipilimumab. Patients were split into two groups, based upon either a positive or negative response to the therapy (5 responders and 11 non-responders). Plasma was collected pre-treatment (baseline) and the first post-treatment time point (week 2 or week 4). Over 400 genes were detected across all samples and time-points. Eleven control mRNAs with robust detection in all samples were used for normalization. When compared in pre- and post-treatment time point patient samples, the analysis identified nine mRNA species with opposite expression changes, pre- and post-treatment, indicating that these genes are involved in response to immunotherapy treatment. A number of mRNA species showed significant differential expression (p-value<0.05) in patients who responded to treatment and those who did not respond across the time points, indicating the presence of distinct RNA profiles for responders and non-responders. Overall, these data demonstrate that Exosome Diagnostics’ proprietary exosomal (exoRNA) platform offers the ability to monitor changes in immune pathway genes serially and longitudinally during immunotherapy treatment. In addition, these initial data signal the potential to detect early signature expression changes in mRNA that could distinguish between patients who are likely or unlikely to respond to treatment. Unlike targeted, cancer treatments, immunotherapy treatments are not linked to specific known underlying mutations. It is difficult for physicians to predict who will respond and, given the current diagnostic landscape, understand if and when a patient is responding to treatment in a time-critical manner. A key source of nucleic acids, including various species of RNA, including mRNA, exosomes are cell messengers found in all living cells and are carried throughout the body via biofluids, such as plasma, urine and cerebrospinal fluid. Using its proprietary exo-RNA-based technology, Exosome Diagnostics can achieve real-time, active access to comprehensive and robust molecular information about cells in the body via a blood draw or urine sample without needing direct access to the cells. This year, Exosome Diagnostics plans to launch ExoDx™ Lung(ALK) and ExoDx™ Lung(EGFR T790M), plasma-based liquid biopsy tests for non-small cell lung cancer, as well as ExoIntelliScore™ Prostate, a urine-based liquid biopsy test for prostate cancer. In addition, the company will launch a blood-based liquid biopsy panel targeting 26 of the most important genes and approximately 1,000 associated mutations in the most significant pathways implicated in lung, colon and breast cancers, including EGFR/MAPK and PI3K. The panel will initially be made available to pharmaceutical companies as a clinical development tool. All of the liquid biopsy tests will launch as laboratory developed tests in the company’s certified CLIA laboratory.
Exosome Diagnostics, Inc. Announces Publication of ExoIntelliScore Prostate Initial Clinical Study Positive Results
Sep 21 15
Exosome Diagnostics, Inc. announced the publication of positive data from its initial clinical study of ExoIntelliScore Prostate (previously referred to as EXO 106). The first-catch urine-based, three-gene signature liquid biopsy test that does not require a digital rectal exam or prostate massage before sample collection predicted high-grade prostate cancer (Gleason score = 7) with 97.5% accuracy prior to initial biopsy. The paper titled, “A molecular signature of PCA3 and ERG exosomal RNA from non-DRE urine is predictive of initial prostate biopsy result,” appears in the current online edition of Prostate Cancer and Prostatic Diseases, a peer-reviewed journal of Nature Publishing Group. Distinct from all other predictive tests on the market or in clinical development for prostate cancer, ExoIntelliScore Prostate is the first assay to give urologists and their patients molecular insights about prostate cancer using exosomal RNA (exoRNA). The test involves patients giving a simple, first-catch urine sample without having to first undergo a digital rectal exam (DRE). ExoIntelliScore Prostate is poised to drive a new prognostic paradigm in which the aggressiveness of prostate cancer can be predicted completely non-invasively from genetic-based information ahead of initial prostate biopsy. For men demonstrating a low-risk for aggressive disease using the assay, urologists may determine that an initial prostate biopsy is not warranted. As a result, ExoIntelliScore Prostate has the potential to help stem the tide of unnecessary biopsies that occur given the current void of accurate pre-initial biopsy prognostic information. ExoIntelliScore Prostate assesses the risk for high-grade prostate cancer in men with an elevated gray zone prostate specific antigen (PSA) (2 – 10 ng/mL) prior to initial biopsy. The test analyzes the expression of three biomarkers utilizing exoRNA and, using a proprietary algorithm, assigns a predictive risk score for patients. A key source of nucleic acids, including RNA, exosomes are cell messengers found in all living cells and are carried throughout the body via biofluids, such as urine, plasma and cerebrospinal fluid. Using exosomes, researchers can achieve real-time access to comprehensive molecular information about cells in the body without needing direct access to the cells. ExoIntelliScore Prostate involves patients submitting a simple, first-catch urine sample to yield deep, accurate genetic insights. Other non-exosome-based predictive urine-based tests on the market and in development require patients to undergo a digital rectal exam (DRE).
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