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September 03, 2015 12:35 AM ET

Biotechnology

Company Overview of Exosome Diagnostics, Inc.

Company Overview

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

Suite 3

Cambridge, MA 02139

United States

Founded in 2008

Phone:

617-588-0500

Fax:

617-588-0580

Key Executives for Exosome Diagnostics, Inc.

Chief Executive Officer and Director
Age: 56
Chief Financial Officer
Age: 44
Chief Science Officer and Founding Scientist
Chief Medical Officer
Vice President of Business Development
Compensation as of Fiscal Year 2015.

Exosome Diagnostics, Inc. Key Developments

Exosome Diagnostics Launches CLIA-Certified Laboratory in Cambridge, Mass.; Closes Operations at its Existing CLIA Laboratory in St. Paul, MN

Exosome Diagnostics, Inc. announced that it has opened a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory in Cambridge, Mass. The clinical services laboratory will manage analysis and reporting for several liquid biopsy tests that the company plans to launch this year for prostate, lung and other solid tumor cancers. These novel diagnostics will help clinicians detect disease sooner and obtain access to real-time molecular insights that can help better inform treatment decisions for patients with cancer and other serious diseases. Coinciding with the Cambridge laboratory's opening, the company has closed operations at its existing CLIA laboratory in St. Paul, MN. The new Cambridge-based CLIA laboratory has taken over the functional operations of the St. Paul lab, and expanded its efforts to enable clinicians to access its molecular diagnostics to support detection, monitoring and treatment stratification.

Exosome Diagnostics, Inc. Presents Data Demonstrating Ability to Detect EGFR Activating Mutations and T790M Resistance Mutation in Patients with Non-Small Cell Lung Cancer

Exosome Diagnostics, Inc. announced data demonstrating the ability of its proprietary exosomal RNA (exoRNA) plus cell-free DNA (cfDNA) platform to detect with high sensitivity EGFR activating mutations and the EGFR T790M resistance mutation in blood plasma of patients with non-small cell lung cancer (NSCLC). The data were presented at a poster session on July 31, 2015, titled, Detection of EGFR activating and T790M resistance mutation in plasma of NSCLC patients using combined exosomal RNA and DNA capture, at the 16th Annual International Lung Cancer Congress, which took place July 30, 2015 - August 1, 2015 in Huntington Beach, Calif. In the study, Exosome Diagnostics applied its exoRNA plus cfDNA platform to isolate 21 blood plasma samples from NSCLC patients collected at the time of clinical resistance to EGFR tyrosine kinase inhibitor (TKI) therapy. The samples were EGFR-genotyped on time-matched tissue from a repeat biopsy. The exoRNA and cfDNA were then simultaneously analyzed utilizing targeted ultra-deep sequencing (UDS) of select genes. The positive concordance of EGFR mutations in metastatic disease was 87% for the activating mutations (EGFR L858R and del19) and 82% for the resistance EGFR T790M mutation. In patients with intra-thoracic disease, these mutations have proven challenging to detect utilizing cfDNA alone. However, by combining exoRNA and cfDNA, Exosome Diagnostics achieved a 67% concordance for activating mutations and 40% for T790M. Patients with EGFR activating mutations often initially respond to treatment with TKIs. However, eventually, many patients lung cancer continues to progress because they develop new, also known as acquired, mutations, including the T790M resistance mutation. Due to these acquired mutations, many patients stop responding to TKI therapy, rendering it ineffective. There are currently several therapies in clinical development that target these acquired mutations in NSCLC. A critical step in matching patients to the most appropriate therapy or clinical trial is being able to detect these mutations as they develop. Molecular tests that require tissue biopsy present several drawbacks. Tissue biopsy provides molecular information about a tumor only at one static point in time. It becomes untenable to do repeat biopsies on NSCLC patients over time, particularly as the disease progresses. In addition, there are issues related to tissue availability and tumor heterogeneity; the tissue extracted during the biopsy may not reflect the complete molecular make-up of the tumor. Biofluid-based molecular diagnostics enable serial, longitudinal monitoring; clinicians can take repeated snapshots of disease throughout treatment, monitoring for drug resistance and emerging mutations in real-time and adjusting treatment course as necessary. In addition, biofluid samples, such as plasma or urine, are more readily available than tissue samples, and are accessible non-invasively.

Exosome Diagnostics, Inc. Presents Data on Plasma-Based Solid Tumor Mutation Panel Liquid Biopsy Test, Demonstrates Excellent Analytical Performance for Detection of Actionable Mutations Across Multiple Cancers

Exosome Diagnostics, Inc. announced data demonstrating the ability of its plasma-based liquid biopsy panel for solid tumors, which co-isolates and analyzes exosomal RNA (exoRNA) and cell-free DNA (cfDNA), to provide robust, highly sensitive detection of actionable mutations in plasma across multiple cancers. The company announced additional data showing that its proprietary exoRNA plus cfDNA platform also enabled plasma-based longitudinal monitoring of BRAF mutant melanoma, and demonstrated the ability to detect early disease progression multiple months prior to clinical evidence of the changes. Exosome Diagnostics is developing innovative plasma- and urine-based liquid biopsies that analyze exoRNA for biomarkers and can simultaneously isolate and analyze cfDNA to enhance detection of rare mutations. The solid tumor liquid biopsy panel and BRAF data were presented in poster sessions at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2 in Chicago, Ill. Based on these and earlier data, Exosome Diagnostics plans to commercialize its solid tumor panel liquid biopsy as a laboratory developed test in the company’s certified CLIA laboratory in 2015. The test, which is performed on simple blood samples, and covers 26 genes and 1,000 associated mutations in the most significant cancer pathways, including EGFR/MAPK and PI3K, will initially be made available to pharmaceutical companies as a clinical development tool. Exosomes are messengers released by all living cells into biofluids, such as plasma/serum, urine, cerebrospinal fluid and saliva. Exosomes contain RNA, DNA and proteins from their cell of origin. Exosome Diagnostics’ technology platform can achieve real-time access to comprehensive molecular information about cells in the body without direct access to the actual cells. In addition to the solid tumor panel, in 2015 Exosome Diagnostics plans to launch plasma-based liquid biopsy tests for the EML4-ALK and EGFR T790M mutations in non-small cell lung cancer (NSCLC), as well as a urine-based liquid biopsy test for prostate cancer. The liquid biopsies will launch as laboratory developed tests in the company’s certified CLIA laboratory in 2015.

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