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Exosome Diagnostics Enters Collaboration Agreement with Lilly for Exosome Blood-Based Biomarker Discovery

Exosome Diagnostics recently announced it has entered into a collaboration agreement with Eli Lilly and Company (NYSE: LLY) for biomarker discovery and validation using Exosome Diagnostics proprietary EXO50 nucleic acid extraction kit. Under the agreement, Lilly will gain early access to Exosome Diagnostics technology to help identify key gene mutations and expression levels in blood that may be correlated with drug response and disease recurrence. Financial terms were not disclosed.

“Exosome Diagnostics technology may provide a unique opportunity to gain insight into the biology of complex conditions such as cancer and immune disorders,” said Andrew Schade, senior medical director, diagnostic and experimental pathology at Lilly. “Exosome technology enables biofluid molecular sampling and the ability to monitor disease progression in real time. As Lilly explores new ways to pursue patient tailoring, we’ll continue to work with partners to expand our capabilities.”

“Accessing high quality messenger and microRNA directly from frozen patient fluid samples offers a rapid, cost-effective route to identify and validate biomarkers, which may be correlated with drug response and disease recurrence,” said James McCullough, chief executive officer of Exosome Diagnostics. “Lilly has accumulated an extensive and well annotated clinical blood sample biobank that provides a unique opportunity to track target biomarkers through the clinical trial process and help overcome the limitations of stored biopsy tissue.”

Exosomes and other microvesicles are secreted by all cells into all biofluids, and provide a natural biological packaging and distribution mechanism for RNA and DNA. Exosome Diagnostics’ rapid exosome isolation and extraction technology produces high-quality RNA and DNA, including full length mRNA and microRNA, from small volumes of patient biofluids, such as blood (serum and plasma), urine and cerebrospinal fluid, for analysis by standard PCR, array and sequencing instruments. Analysis can be performed on fresh or frozen fluid samples, allowing for broad, flexible and convenient analyses of clinical trial samples, both in real-time and retrospectively, with no special preservation methods required. Exosomes and their protected nucleic acid contents are being investigated in a broad range of diseases including cancer, CNS disorders such as Alzheimer’s and Parkinson’s disease, cardiovascular disease, maternal/fetal medicine, and chronic kidney disease, among others. In July, QIAGEN and Exosome Diagnostics signed an agreement for the creation of High-Performance Biofluid Sample Preparation Kits for Personalized Healthcare Research which covers the exclusive supply of these products upon availability in 2014.

Source: Exosome Diagnostics

Agilent Technologies Launches New AssayMAP Peptide Sample-Prep Solution

Agilent Technologies Inc. (NYSE: A) recently announced the launch of its new AssayMAP peptide sample-prep solution, which offers automated protein digestion, peptide cleanup and fractionation in preparation for mass-spectrometry analysis.

As more scientists adopt LC/MS analysis for biomarker discovery, the bottleneck shifts to sample preparation. As these types of studies involve much larger numbers of samples, traditional manual methods are proving untenable in terms of hands-on time and unreliable in terms of reproducibility.

“Using the combination of extremely consistent, parallelized digestion with automated reverse-phase cleanup via AssayMAP, at a scale appropriate for ultrasensitive proteomics applications, has enabled us to contemplate collaborative studies of previously unheard-of scales and throughput,” said Jacob Jaffe, Ph.D., assistant director of proteomics platforms at the Broad Institute in Cambridge, Mass.

“The AssayMAP peptide sample-preparation solution is one of the ways Agilent is addressing the need for high-throughput, reproducible sample-preparation methods in front of precision analytical instruments,” said Kathleen Shelton, senior director of automation marketing at Agilent. “Agilent’s unique ability to deliver high-quality solutions for automating sample preparation through analysis enables scientists to maximize workflow productivity and be more successful.”

AssayMAP helps address the bottleneck created with traditional sample preparation for mass-spec analysis and enables unprecedented precision and throughput. This easy-to-use solution includes validated automation protocols driven through intuitive software, the AssayMAP Bravo liquid-handling instrument, and a suite of AssayMAP cartridges optimized for peptide cleanup and fractionation. The AssayMAP peptide sample-prep solution makes large campaigns possible for mass-spec analysis, leveraging the strength of this analytical method to unambiguously identify peptides.

Source: Agilent Technologies

Life Technologies Signs Five-Year Agreement with the FDA

Life Technologies Corporation (NASDAQ: LIFE) recently announced that it has signed a five-year agreement with the Food and Drug Administration (FDA) to accelerate and advance food safety testing of E. coli and Salmonella, two foodborne contaminants commonly associated with outbreaks and/or recalls.

The collaboration consists of three distinctive projects:

  • Life Technologies will design and validate new food safety tests for the detection and identification of foodborne pathogens, with pathogen strains provided by the FDA.
  • Life Technologies will design and validate a complete workflow for food pathogen detection on the Ion PGM™ platform, while optimizing sample preparation methods.
  • The FDA will have the opportunity to evaluate new disruptive technology platforms by Life Technologies for the use in pathogen detection.

Life Technologies will use its bioinformatics resources to independently develop real-time PCR (polymerase chain reaction) assays against unique E. coli and Salmonella targets in collaboration with the FDA. It will then provide the test results for these targets to the FDA for further validation.

The FDA will use Life Technologies’ Ion PGM™ Sequencer to generate whole genome sequence information from defined bacteria, and for strains that will be excluded from detection. Life Technologies’ bioinformatics team will then analyze the genomic information and provide assays or tests to the FDA for further validation and analysis. Whole genome sequences generated under the collaboration will be added to the National Institutes of Health Genbank so they can be accessed by the food safety research community.

“We are excited to be entering this cooperative research and development agreement with the FDA as we have been working alongside them in one capacity or the other for over 10 years,” said Nir Nimrodi, Vice President and General Manager for Food Safety and Animal Health at Life Technologies. “The FDA will call on us, particularly when it comes to developing rapid detection kits. This agreement allows them to have new rapid track and trace products for rapid identification of foodborne contaminants.”

Lastly, the FDA will validate and test Life Technologies’ next-generation sequencing technologies for Salmonella investigations as part of its effort to develop new rapid detection tools that can improve the public health response to future outbreaks.

Life Technologies has a strong history of combating pathogen outbreaks. In 2011, Life Technologies developed a custom assay to accurately detect the highly pathogenic E. coli 0104:H4 bacterium that spread through Europe, killing hundreds of people.

“The assay was developed using samples supplied by scientists at University Hospital Munster, who completed the DNA sequencing and analysis work on the deadly E. coli strain using the Ion PGM™ Sequencer,” said Maneesh Jain, Ion Torrent Vice President of Marketing for Life Technologies. “Now the FDA will validate and test this same technology to understand the molecular relationship within the Salmonella pathogen in the hopes to prevent future outbreaks from occurring.”

The PGM™ offers scientists the simplest and fastest workflow, lowest cost-per-sample, and highest sensitivity for multiple basic and clinical research applications.

Source: Life Technologies

Firefly Bioworks Releases Expanded Multiplexed MicroRNA Assay

Recently, Firefly BioWorks announced the expansion of its microRNA assay, FirePlex® miRSelect, from a maximum of 23 multiplexed microRNAs to 68.

“The expanded capability of miRSelect will resonate with researchers looking to validate early discovery studies on statistically significant numbers of samples. This latest version of miRSelect is an important step toward our mission of enabling all scientists to engage those ambitious explorations that are considered too expensive, labor intensive or time consuming with existing technology,” says Dr. Davide Marini, co-founder and Chief Executive Officer of Firefly BioWorks. The expanded Firefly platform allows for rapid and cost-effective testing of large numbers of samples across more microRNA targets than ever before. In addition to validation studies, miRSelect is applicable to a broad array of research areas, including biomarker discovery, translational research, developmental biology and model organism research.

FirePlex® miRSelect is a rapid, robust, and sensitive method for multiplexed detection of microRNAs across a wide range of sample types. The product does not require purchase of dedicated equipment or lengthy sample preparation protocols. Instead of using predefined microRNA panels, researchers can build a panel customized to their needs, by choosing 10 to 68 targets from miRBase or by specifying novel sequences. For scientists approaching the field of microRNA for the first time, Firefly BioWorks offers a special-purpose search engine (PubmiR) to provide objective ranking of the most important microRNAs associated with specific diseases or biological pathways, according to published literature.

“The goal of this release is to provide researchers with the maximum flexibility, both in terms of number and nature of microRNA targets to be profiled in each sample,” says Dr. Daniel Pregibon, co-founder and Chief Technology Officer of Firefly BioWorks.

Firefly BioWorks was founded to commercialize an innovative, open approach to multiplexed detection of biomolecules. The company’s flagship product, FirePlex® miRSelect, enables high-throughput and targeted microRNA profiling by flow cytometry. The product is also available as a service.

Source: Firefly BioWorks

Olink Bioscience Introduces Scalable Protein Biomarker Assays with Proseek Multiplex

Molecular tools specialist Olink today launched Proseek® Multiplex – a new generation of multiplexed protein biomarker immunoassays based on its proprietary Proximity Extension Assay (PEA) platform. Until now, it has been impossible to scale up conventional assays due to increased antibody cross-reactivity when large numbers of assays are run simultaneously. Now with the introduction of Proseek Multiplex, biomarker researchers can quantify 92 proteins in just one microliter sample without compromising data quality or performance.

“We are very proud at Olink to introduce a new and scalable era in immunoassays. Proseek has harnessed the tools that have fueled genomics for many years and put them to use in protein biomarker research. In a few years, we aim to offer the market’s most comprehensive portfolio of protein biomarker assays.” says Simon Fredriksson, CEO of Olink Bioscience.

First in the range is Proseek Multiplex Oncology I 96×96, a ready-to-use kit sold by Olink capable of analyzing 96 samples against a panel of analytes such as growth factors, inflammatory markers, soluble receptors, and cancer antigens. Further Proseek 92-plex panels for cardiovascular disease, inflammation, and diabetes will be introduced through 2013.

Minimal sample consumption makes Proseek Multiplex especially suitable for retroactively mining precious biobanked serum samples for novel multivariate biomarker signatures. It can also provide novel biomarker insights from sample types such as tissue lysates of needle biopsies and micro dialysis samples. Even in these small samples Proseek Multiplex can provide accurate quantification below pico-gram per milliliter levels.

Proseek is based on the proprietary PEA technology developed at Olink. PEA is a homogeneous assay that uses pairs of antibodies equipped with DNA reporter molecules which upon target binding give rise to new DNA amplicons each ID-barcoding their respective antigens. Cross-reactive events are not detected since the sequence design allows only the correctly matched antibody pairs to give rise to a signal. The amplicons are subsequently quantified by high throughput real-time PCR.

“This is major breakthrough. Suddenly the extremely sensitive, reproducible and reliable qPCR workflow since long established as the gold standard for DNA, mRNA, and microRNA analyses has become available also for the measurement of proteins. During our early access period we have established robust SOPs for the entire workflow from sample preparation to data analysis, and it will be a great pleasure supporting our clients with this exceedingly powerful new technology to advance their research.” says Professor Mikael Kubista, founder of TATAA Biocenter and renowned for his pioneering work in real time-PCR.

Source: Olink Bioscience