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October 2015 - Issue 2
Welcome to Battelle’s Life Sciences Research CRO+ Today Newsletter. The Battelle Life Sciences Research team provides fast, accurate answers for discovery, safety and efficacy with our integrated scientific and technological capabilities, world-class facilities and ability to meet technical, development and regulatory needs. Battelle Life Sciences CRO+ Today will keep you up-to-date on cutting-edge life sciences research.
Researchers at Battelle have developed a multiplex molecular assay that screens for up to 60 different pathogens. The two-panel assay offers the broadest PCR-based molecular multiplex capacity currently available, significantly reducing the time and costs of testing for multiple pathogens.
Most PCR-based assays test for one or a handful of pathogen species at a time. The new test uses two assay panels that together screen for 60 different pathogens in human, animal or environmental (soil and water) samples. The first panel is focused on febrile illnesses such as Ebola, dengue virus and bacillus anthracis (anthrax). The second panel tests for vector-born pathogens such as anaplasma, babesia and rickettsia, all tick-borne diseases. The same development method could be applied to create other broad multiplex assays for different types of pathogens.
Multiplex molecular assays streamline laboratory processes and increase the amount of information that you can get with the same amount of work. Instead of conducting 60 individual assays, laboratory workers can now simply run two panels to screen for dozens of pathogens at once. However, developing multiplex molecular assays that are both sensitive and specific enough to pinpoint this many species in a single panel is a significant bioinformatics challenge. Most multiplex PCR-based assays available on the market today test for a dozen or fewer pathogens at a time.
Researchers at Battelle apply advanced bioinformatic and genomic methods to develop customized individual and multiplex molecular assays for a wide variety of applications, from medical screening to environmental research. They can develop custom molecular assays for any pathogen of interest. They also perform characterization and validation studies to help clients understand the limits of detection and how the assay will perform under different parameters.
By solving the technical challenges around broad multiplex molecular assays, researchers have now opened up new opportunities to further streamline laboratory processes and reduce the time required to identify pathogen species. They can now apply this capability to develop additional multiplex assays around different pathogens of interest, depending on the needs of each client.
Battelle is pleased to have been awarded a five-year, $9 million Indefinite Delivery/Indefinite Quantity (IDIQ) contract by the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP). Through this contract, Battelle’s Life Sciences Research team in West Jefferson, Ohio, will help the FDA characterize the toxicity of the various ingredients in tobacco products, including new harm-reduction products like e-cigarettes.
The research will help the FDA define the regulations needed to implement the Family Smoking Prevention and Tobacco Control Act. This act gives the FDA authority to regulate the manufacturing, marketing, and distribution of tobacco products to protect the public health.
“This contract win demonstrates that the FDA sees the breadth of capabilities available at Battelle to accomplish their tobacco research goals. We can help them understand tobacco products from a variety of aspects – from human behaviors and addiction to toxicological effects,” said April Brys, a manager in the Life Sciences Research business unit.
In recent years, there has been an explosion of new tobacco and nicotine product options, including e-cigarettes and oral nicotine delivery products. While use of traditional cigarettes has declined, interest in newer products like tiny flavored cigars, waterpipes and vaporizers with flavored tobacco products has grown, especially among youth. Research is desperately needed to study exposure levels, toxicity and behavioral impacts of these new products.
Battelle has a long history of work in tobacco research. Since the 1970s, Battelle researchers have been on the front lines of tobacco research with extensive experience in testing cigarettes and tobacco products to uncover any toxic effects on users. The Battelle Public Center for Tobacco Research is nationally and internationally known for cutting-edge work with a wide variety of tobacco and nicotine products, including cigars and cigarettes, smokeless tobacco products, e-cigarettes, waterpipes and other emerging tobacco and nicotine delivery products.
Under this new award, Battelle Life Sciences Research will perform in vivo inhalation studies to understand the toxicity of tobacco product components, ingredients, byproducts (smoke, aerosols, etc.), and additives, including other constituents, flavors, humectants, essential oils, resins, and herbal extracts, from traditional tobacco products (cigarettes, cigars, cigarillos, etc.), electronic cigarettes, electronic cigarette solutions, and other nicotine delivery systems.
“What are the toxic effects of tobacco products? And, how can we ensure that new products marketed as safer are indeed safer? These are important questions to answer as the FDA seeks to regulate the tobacco industry. We’ll do our best science to help them understand and calculate consumer risk,” said April.
Dr. Vijaykumar (Vijay) Kale is working to bring better and safer drugs to market. His long-term goal is to find methods that make pre-clinical toxicology work more efficient and accurate for drug developers. Read More