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In it together
SAN JOSE, Calif.—Thermo Fisher Scientific Inc. has reached an agreement with Cerilliant Corp. to develop and manufacture certified solution standards for the Thermo Scientific ToxSpec analyzer.
Under a marketing agreement announced in January, Cerilliant will develop a number of ready-to-use certified solution standards for use with the ToxSpec LC/MS analyzer for drugs-of-abuse analysis in forensic and clinical research laboratories. The collaboration aims at achieving a cost-effective solution to address the need for standardization of controls and assays in testing laboratories.
According to Subodh B. Nimkar, Thermo Fisher Scientific's marketing strategic manager for clinical research and forensic toxicology, Cerilliant is one of the leading and most well-respected suppliers of certified standards for drugs-of-abuse analysis, so it was a natural partnership.
Cerilliant, a privately held Texas corporation located in an Austin suburb, has been producing analytical reference standards for almost 30 years. Formerly known as the Analytical Reference Materials Division of Radian International, the company claims to have been the first to produce 13C labeled chlorinated dioxins and furans in cooperation with Cambridge Isotope Laboratories. Cerilliant was also the first to offer isotope-labeled drugs-of-abuse reference standards to the forensic drug testing industry and pioneered DEA exempt preparations of controlled substances in solution. Since its spin-off from Radian in August 2000, Cerilliant has grown from 23 to over 60 employees and now serves more than 2000 active customers.
Scientists performing drugs-of-abuse analysis in forensic and clinical research laboratories currently face challenges because a large number of different testing methods are used within the industry with no standardization of reagents, notes Cerilliant Vice President of Sales and Marketing Mitzi Rettinger.
This leads to difficulties in inter-lab validation studies and inconsistencies in results. Certified standards tested for specific assays on relevant platforms will, to a large extent, address this major issue—leading to wider adoption of the technology provided by Thermo and others. Cerilliant's certified Snap-N-SpikeT/Snap-N-Shoot—used as calibration and quantitation solutions for the ToxSpec analyzer—are standardized solutions that are performance tested for reliability and effectiveness.
"We were pioneers in the development of ready-to-use, solution-based reference standards," Rettinger says. "All of our standards are thoroughly characterized and provided in a shelf-stable, efficient and accurate format suitable for quantitative applications."
"Certified standards are one of the key components of a truly comprehensive solution for the forensic toxicology market, including pain management labs, Nimkar says—but are missing from today's traditional LC/MS-based systems.
"Thermo Fisher Scientific plans to fill the void by offering tested solutions that will simplify the laboratory workflow, while at the same time making it more robust," he notes.
The ToxSpec analyzer combines proven mass spectrometry hardware with automated, online sample preparation, and cross-sequential multiplexing (ability to run 4 different assays simultaneously using one mass spectrometer). In addition, it offers robust library searching software and a large spectral library of drugs. The analyzer comprises integrated software, hardware and methodologies for forensic toxicology and simplifies the process of running assays while reducing analysis time and increasing confidence in compound identification.
The Cerilliant collaboration will aim at the development of analytical methodologies designed to meet clinical research and forensic toxicology laboratories' increasingly strict regulatory requirements as well as the need to process assays in a much shorter time. The certified solution standards come with complete certificates of analysis and require no preparation or testing, resulting in accelerated turn-around times and significant savings. Cerilliant solutions offer a high confidence in results using certified standards tested for specific assays and consistent results across different labs, Nimkar adds.