Exosome chooses Life

NEW YORK—Exosome Diagnostics has reached an agreement withLife Technologies to use the Applied Biosystems (ABI) 7500 Fast Dx Real-TimePCR Instrument for the company's exosome biofluid in-vitro diagnostics oncology program. Exosome Diagnosticsplans to validate the ABI instrument platform with exosome biofluid RNAisolation technology kits in upcoming multicenter clinical trials in braincancer and prostate cancer.

The ABI 7500 Fast Dx Real-Time PCR Instrument is one of themost widely distributed PCR platforms in laboratories worldwide and is clearedby the U.S. Food and Drug Administration.

"Our product development strategy is to match ourexosome-based diagnostics technology with the most technically appropriate andwidely accepted platforms available," says David Okrongly, chief operatingofficer of Exosome. "The ABI 7500 Fast Dx Real-Time PCR Instrument combinesstate-of-the-art quantitative PCR (qPCR) technology with broad market andregulatory acceptance, enabling physicians and laboratory customers toefficiently and accurately access diagnostic results."

Ron Andrews, president of medical sciences at LifeTechnologies, adds, "We are pleased to be partnered with Exosome Diagnostics asthey develop their non-invasive cancer diagnostic programs. Our medicalsciences strategy is focused on partnerships with emerging companies that havepromising molecular diagnostic applications that enable the realization ofpersonalized medicine in diseases like cancer."

Exosome is developing a series of urine- and blood-basedmolecular diagnostic tests for use in cancer detection and monitoring. Thecompany's technology can isolate a highly pure, stable preparation ofribonucleic acids from biofluids for analysis on existing analytical platformssuch as qPCR and next-generation sequencing. The company is currently in theprocess of partnering with various manufacturing groups to provide branded, OEMin-vitro diagnostic solutions forregulatory approval and use in the company's GLP CLIA-certified laboratory.

"This agreement with Life Technologies continues our pursuitof best-in-class partnerships that include the Prostate Cancer Foundation,Accelerate Brain Cancer Cure (ABC2) and the broad group of leading clinicalinvestigators now collaborating on exosome technology," says James McCullough,Exosome's CEO. "Life Technologies is leading the way in personalized medicineand provides us with the type of customer service and robust technology thatare prerequisites to the successful launch of innovative moleculardiagnostics."

Exosomes are shed into all biofluids, including blood, urineand cerebrospinal fluid, forming a stable source of intact, disease-specificnucleic acids. The eponymous company's proprietary exosome technology makes useof this natural stability to achieve high sensitivity for rare gene transcriptsand the expression of genes responsible for cancers and other diseases.

Exosome is commercializing in-vitro diagnostic tests for use in companion diagnosticapplications and real-time monitoring of disease. Earlier this year, thecompany announced a collaboration with ABC2 and unnamed academic medicalcenters to accelerate clinical validation of Exosome's blood and cerebrospinalfluid-based molecular diagnostics technology in brain cancer. The collaborationwill explore the capabilities of Exosome RNA biofluid-based diagnostictechnology for early identification, progression monitoring and disease-riskstratification in glioma, the most common and deadly form of brain cancer.

In two clinical studies, also completed this year, resultsdemonstrated the potential utility of non-invasive sampling of patients' urineto detect and manage prostate cancer. In the first study, the presence of aprostate cancer-specific biomarker in exosomes collected from random patients'urine samples demonstrated a strong correlation to the presence of that markerin prostate tissue removed via radical prostatectomy. The study also correlatedthe expression level of the marker in urine with the likelihood of a positivecancer biopsy. In the second study, urinary exosomes demonstrated elevatedlevels of survivin messenger RNA from patients with castration-resistantprostate cancer following primary therapy. Survivin expression has beenimplicated in hormone-independent prostate cancer growth.

Life Technologies and OpGen to develop microbial outbreaksolutions

CARLSBAD, Calif.—Life Technologies Corp. also announced lastmonth that it has signed a collaborative agreement with OpGen Inc. to developsystems, technologies and applications intended to improve the management andsurveillance of microbial outbreaks in the public health and infectious diseasemarkets.

The collaboration will focus on developing applications andanalysis systems that enable the use of the companies' Whole Genome Mapping andIon Torrent sequencing technologies for food outbreak and infectious diseaseanalysis. OpGen's Whole Genome Mapping technology provides a rapid,comprehensive structural analysis of microbial genomes that, when combined withsequencing data, more accurately detects important novel genetic elementsassociated with toxicity, virulence and drug resistance.

As part of the collaboration, Life Technologies will alsojoin the public health consortium recently established by OpGen to evaluateWhole Genome Mapping and sequencing for confirmation and management of diseaseoutbreaks.

"Life Technologies is the ideal partner to demonstrate thevalue of next-generation sequencing in the public health and hospitallaboratory," said Douglas White, CEO of OpGen. "OpGen's Whole Genome Mappingtechnologies, in conjunction with the Ion Torrent system, will provide a valuablenew approach that will provide public health and clinical laboratories accessto cutting-edge technologies for microbial analysis and outbreak management."

"Just six months after we launched the PGM and released thefirst semiconductor sequencing chip, scientists in China and Germany used Ion'stechnology to decode the genome of the deadly German E. coli outbreak strain and rapidly identify its uniquecombination of toxins and virulence genes," said Gregg Fergus, president of IonTorrent, part of Life Technologies. "We are excited to be collaborating withOpGen because of their focus on delivering improved infectious diseasedetection capabilities to PGM and Whole Genome Mapping enabled laboratories ona global basis. The PGM is the only sequencing platform with the speed,simplicity and scalability to allow public health officials to intervene inongoing infectious disease outbreaks."

OpGen Inc.