Exosome chooses Life
July 2012
by Lloyd Dunlap  |  Email the author


NEW YORK—Exosome Diagnostics has reached an agreement with Life Technologies to use the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument for the company's exosome biofluid in-vitro diagnostics oncology program. Exosome Diagnostics plans to validate the ABI instrument platform with exosome biofluid RNA isolation technology kits in upcoming multicenter clinical trials in brain cancer and prostate cancer.  
The ABI 7500 Fast Dx Real-Time PCR Instrument is one of the most widely distributed PCR platforms in laboratories worldwide and is cleared by the U.S. Food and Drug Administration.  
"Our product development strategy is to match our exosome-based diagnostics technology with the most technically appropriate and widely accepted platforms available," says David Okrongly, chief operating officer of Exosome. "The ABI 7500 Fast Dx Real-Time PCR Instrument combines state-of-the-art quantitative PCR (qPCR) technology with broad market and regulatory acceptance, enabling physicians and laboratory customers to efficiently and accurately access diagnostic results."  
Ron Andrews, president of medical sciences at Life Technologies, adds, "We are pleased to be partnered with Exosome Diagnostics as they develop their non-invasive cancer diagnostic programs. Our medical sciences strategy is focused on partnerships with emerging companies that have promising molecular diagnostic applications that enable the realization of personalized medicine in diseases like cancer."  
Exosome is developing a series of urine- and blood-based molecular diagnostic tests for use in cancer detection and monitoring. The company's technology can isolate a highly pure, stable preparation of ribonucleic acids from biofluids for analysis on existing analytical platforms such as qPCR and next-generation sequencing. The company is currently in the process of partnering with various manufacturing groups to provide branded, OEM in-vitro diagnostic solutions for regulatory approval and use in the company's GLP CLIA-certified laboratory.  
"This agreement with Life Technologies continues our pursuit of best-in-class partnerships that include the Prostate Cancer Foundation, Accelerate Brain Cancer Cure (ABC2) and the broad group of leading clinical investigators now collaborating on exosome technology," says James McCullough, Exosome's CEO. "Life Technologies is leading the way in personalized medicine and provides us with the type of customer service and robust technology that are prerequisites to the successful launch of innovative molecular diagnostics."  
Exosomes are shed into all biofluids, including blood, urine and cerebrospinal fluid, forming a stable source of intact, disease-specific nucleic acids. The eponymous company's proprietary exosome technology makes use of this natural stability to achieve high sensitivity for rare gene transcripts and the expression of genes responsible for cancers and other diseases.  
Exosome is commercializing in-vitro diagnostic tests for use in companion diagnostic applications and real-time monitoring of disease. Earlier this year, the company announced a collaboration with ABC2 and unnamed academic medical centers to accelerate clinical validation of Exosome's blood and cerebrospinal fluid-based molecular diagnostics technology in brain cancer. The collaboration will explore the capabilities of Exosome RNA biofluid-based diagnostic technology for early identification, progression monitoring and disease-risk stratification in glioma, the most common and deadly form of brain cancer.
In two clinical studies, also completed this year, results demonstrated the potential utility of non-invasive sampling of patients' urine to detect and manage prostate cancer. In the first study, the presence of a prostate cancer-specific biomarker in exosomes collected from random patients' urine samples demonstrated a strong correlation to the presence of that marker in prostate tissue removed via radical prostatectomy. The study also correlated the expression level of the marker in urine with the likelihood of a positive cancer biopsy. In the second study, urinary exosomes demonstrated elevated levels of survivin messenger RNA from patients with castration-resistant prostate cancer following primary therapy. Survivin expression has been implicated in hormone-independent prostate cancer growth.

Life Technologies and OpGen to develop microbial outbreak solutions
CARLSBAD, Calif.—Life Technologies Corp. also announced last month that it has signed a collaborative agreement with OpGen Inc. to develop systems, technologies and applications intended to improve the management and surveillance of microbial outbreaks in the public health and infectious disease markets.
The collaboration will focus on developing applications and analysis systems that enable the use of the companies' Whole Genome Mapping and Ion Torrent sequencing technologies for food outbreak and infectious disease analysis. OpGen's Whole Genome Mapping technology provides a rapid, comprehensive structural analysis of microbial genomes that, when combined with sequencing data, more accurately detects important novel genetic elements associated with toxicity, virulence and drug resistance.  
As part of the collaboration, Life Technologies will also join the public health consortium recently established by OpGen to evaluate Whole Genome Mapping and sequencing for confirmation and management of disease outbreaks.  
"Life Technologies is the ideal partner to demonstrate the value of next- generation sequencing in the public health and hospital laboratory," said Douglas White, CEO of OpGen. "OpGen's Whole Genome Mapping technologies, in conjunction with the Ion Torrent system, will provide a valuable new approach that will provide public health and clinical laboratories access to cutting-edge technologies for microbial analysis and outbreak management."  
"Just six months after we launched the PGM and released the first semiconductor sequencing chip, scientists in China and Germany used Ion's technology to decode the genome of the deadly German E. coli outbreak strain and rapidly identify its unique combination of toxins and virulence genes," said Gregg Fergus, president of Ion Torrent, part of Life Technologies. "We are excited to be collaborating with OpGen because of their focus on delivering improved infectious disease detection capabilities to PGM and Whole Genome Mapping enabled laboratories on a global basis. The PGM is the only sequencing platform with the speed, simplicity and scalability to allow public health officials to intervene in ongoing infectious disease outbreaks."
                             OpGen Inc. 
Code: E071216

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