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On the cutting edge
April 2016
by Jeffrey Bouley  |  Email the author
EDIT CONNECT

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We begin with droplets (as in digital PCR) for diagnosis and StarDrop for discovery, and then move on to purifying transfection-quality plasmid DNA, the finer points of pipetting tips, registration tracking and submission archiving, thermal cycling and finally supply chain management. Not much of a theme there, but plenty of variety this month.
 

Bio-Rad achieves a first in digital PCR diagnostics
 
HERCULES, Calif.—Late February brought news from Bio-Rad Laboratories Inc. that it received CE IVD marking for its QX200 Droplet Digital PCR (ddPCR) System—the first digital PCR system with the CE IVD mark for use as an in-vitro diagnostic (IVD) in the European Union.
 
“CE IVD marking of the QX200 ddPCR System is Bio-Rad’s first step in extending ddPCR technology to the clinic,” said Annette Tumolo, executive vice president for Bio-Rad’s Digital Biology Group. “As a diagnostic tool, our system is fast and cost-effective, making it ideal for realizing the promise of precision medicine.”
 
One aspect of cancer precision medicine that will be rapidly influenced by the QX200 ddPCR System is liquid biopsy, an increasingly popular technique used to non-invasively genotype tumors, track treatment efficacy and predict cancer recurrence. This form of biopsy shows great promise for guiding treatment decisions. Prospective trials are currently underway to evaluate the effectiveness of liquid biopsy in a clinical setting and, specifically, the utility of combined droplet-based digital PCR and next-generation sequencing in analyzing genomic alterations.
 
Since 2011, Bio-Rad’s Droplet Digital PCR has been available for research use only. The technology, which partitions a DNA or RNA sample into 20,000 droplets and amplifies targeted sequences within each droplet, allows scientists to precisely detect and quantify low concentrations of target DNA and RNA sequences. This enables a range of important genomic applications, including cancer mutation detection, gene copy number determination, viral load monitoring and gene edit detection.
 

Optibrium supports global health through academic and not-for-profit consortium
 
CAMBRIDGE, U.K.—Optibrium, a developer of software for small-molecule drug discovery and optimization, recently announced it will make its StarDrop technology available to an international consortium of academic and not-for profit organizations. Under the agreement, licensed access to StarDrop software will be provided to support drug discovery projects as part of a global health program focused on developing new treatments for neglected diseases.
 
Consortium partners are involved in projects to facilitate and speed up the development of therapies for the treatment of so-called “neglected” diseases such as leishmaniasis, sleeping sickness, Chagas disease, malaria, tuberculosis and pediatric HIV.
 
“Drug development is enormously time consuming, expensive and high risk, due to the challenge of finding high quality candidate drugs with the right balance of efficacy and safety,” said Dr. Matthew Segall, Optibrium’s CEO. “By adopting StarDrop, consortium partners will have global access to a wide range of tools allowing their researchers to quickly target compounds with the highest chance of success and avoid missed opportunities.”
 
Partner organizations included in the agreement are: Anacor, Broad Institute, Epichem, Infectious Disease Research Institute, Medicines for Malaria Venture, Sandexis, TB Alliance, UNICAMP, University of California San Diego, University of Cape Town, University of Dundee and University of Liverpool.
 

Plasmid prep made Zyppy-er by Zymo
 
IRVINE, Calif.—The Zyppy Plasmid Miniprep Kit features a pellet-free modified alkaline lysis method that bypasses bacterial culture centrifugation and resuspension steps common to classical plasmid preparation procedures. Reportedly, this offers high-quality plasmid DNA in eight minutes and Zymo Research calls it “The fastest, easiest miniprep available for purifying transfection-quality plasmid DNA.”
 
Although the specific example isn’t life-sciences-oriented, the company recently shared news that John Blazeck and colleagues have genetically altered multiple targets of lipogenesis simultaneously in the fungus Yarrowia lipolytica for biofuel applications. Zyppy allowed researchers to quickly and easily create a genetically engineered Y. lipolytica strain capable of efficiently producing the highest reported lipid content and lipid concentration to date.
 

Eppendorf talks pipette tips
 
HAMBURG, Germany—Eppendorf notes that often, experimental data were not reproducible even though all variables within the experimental procedure withstood a review, asking “But was that really so?” In many cases, the company says, the assumption is made that the pipetting system, consisting of pipette and pipette tip, is not a source of error as long as the tip fits the pipette. “However, even if this is the case, it does not speak to the precision and accuracy of the pipetting result. Therefore the international standard ISO 8655:2002 recommends the use of pipettes and tips of the same manufacturer. With good reason.
 
“Only under these conditions the client can be sure that each lot of manufactured pipette tips represents exactly the calibration result described in ISO 8655:2002. This is not the case for a non-system supplier; a non-system supplier does not have any system specifications to which he must refer. Hence, the user is forced to perform calibrations and, if necessary, adjustments of his pipette with the foreign tips—every time tips of a new lot number are used.”
 
Eppendorf addresses the issue more in discussing the results of a large-scale study in which a broad array of factors was identified that may negatively influence pipetting results in Application Note 354 “The Tip of the Iceberg—how tips influence results” at www.eppendorf.com/eptips.
 

Bristol-Myers Squibb selects Veeva Vault RIM
 
BARCELONA, Spain—Veeva Systems Inc. announced in late February that Bristol-Myers Squibb has selected Veeva Vault Registrations and Veeva Vault SubmissionsArchive, two next-generation regulatory solutions from the Vault RIM suite, to manage registration tracking and submission archiving globally.
 
The Vault RIM suite allows life-sciences companies to align regulatory processes worldwide, improving speed, agility and compliance. With Vault RIM, companies have real-time access to submission plans, product registration status, health authority correspondence and commitments, and local market submissions. The resulting visibility streamlines global processes and improves data quality, helping companies respond faster to business changes.
 
“Life-sciences companies struggle to manage product submissions and registration information around the world,” said John Lawrie, director of Veeva Vault RIM. “Veeva understands the breadth of this challenge and has introduced a unified solution that helps harmonize global operations and provides the visibility organizations need to manage their product portfolio more effectively.”
 
Vault RIM is part of Veeva Vault, a cloud-based regulated content management platform and suite of applications designed for life sciences. The Veeva Vault family of applications span clinical, quality, commercial, medical, and regulatory to ensure one trusted source for content and data across the enterprise.
 

PCRmax launches updated Alpha Cycler 4 software
 
STAFFORDSHIRE, U.K.—PCRmax, a Bibby Scientific company, recently announced its plans to showcase the Alpha Cycler 4 and its accompanying software update at Arab Lab 2016 in late March. The Alpha Cycler 4 is, the company says, the only commercially available thermal cycler to offer four totally independent blocks. Coupled with updated intuitive software, the Alpha Cycler 4 is able to enhance the value of each PCR run, by allowing users to streamline the workflow, and improve productivity and results.
 
This second version of the Alpha Cycler 4 software allows users to monitor time until runs complete via the Alpha Track monitoring app. The app also reports error messages back to PCRmax, on system health and condition, thus allowing PCRmax to monitor each unit, and spot problems before they occur. This feature limits the chance of end-users wasting reagents, time and money, or using an underperforming system. Additionally, the reporting feature acts similarly to a preventative maintenance check each time the report is sent back to the PCRmax technical support team. Ultimately, the feature is intended to provide end-users with the confidence that their instrument will continually perform to a high standard.
 
Commenting on the launch of the Alpha Cycler 4 software update, Dr. Andrew Birnie, business development specialist said: “PCRmax is always striving for ways to prove their commitment to improving their offering, in line with customer requirements. Although thermal cyclers are widely used, instrumentation can actually have the potential to hinder the results obtained. Software in particular can pose challenges, as it can be cumbersome and inefficient, causing a lack of confidence in the results produced. Coupled with this the cost of a failed run can have a huge impact on research. However, the new software update for the Alpha Cycler 4 provides users with more control and confidence, and aims to overcome challenges regularly encountered.”
 

FusionOps introduces prescriptive analytics for supply chain
 
MOUNTAIN VIEW, Calif.—Late March saw FusionOps, provider of the Supply Chain Intelligence Cloud, announce that the FusionOps cloud platform has been extended to include predefined prescriptive analytics. Business users now, for the first time, have access to data science-backed recommendations that they can trust to optimize their inventory in order to reduce their operational cost and improve customer service levels.
 
While advances are being made in the realm of data science, companies struggle to apply these new analytics to achieve better results, the company says, adding that until now, companies that wanted to extract actionable intelligence from disparate data sources had to rely on IT and teams of data scientists who had only complicated software tools to compile, harmonize, and translate for the business users to then have the chance to act on it for the benefit of the business.
 
“We continue to innovate on our Supply Chain Intelligence Cloud to deliver real results for our customers,” said Gary Meyers, CEO of FusionOps. “Delivering prescriptive analytics for inventory in addition to our existing diagnostic and predictive analytics is a natural evolution for FusionOps and a quantum leap for business users. We are opening the door to the latest in data science and putting it into the hands of people who need it the most, business users.”
 
Code: E041629

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