CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--Instem, a leading provider of IT solutions to the global life sciences market, is pleased to announce that leading research organizations are deploying the Cyto Study Manager software solution to support pioneering regulatory genetox testing techniques.
Clients across Europe and North America are using ‘MicroFlow®’ micronucleus kits from Litron Laboratories, in conjunction with the Micronucleus Module of Cyto Study Manager. By combining the MicroFlow method with Cyto Study Manager’s experiment set-up and automatic reporting, those clients are benefiting from considerable time savings, while ensuring accurate and reproducible results.
- MicroFlow micronucleus kits utilize flow cytometry to offer quick and reproduceable, high-quality data generated by an internationally validated method
- Cyto Study Manager integrates genetox data acquisition, auditing, reporting and study management into a single GLP compliant system to deliver a range of measurable benefits
- Organizations around the world are now able to make use of the extensive reporting capabilities within Cyto Study Manager and more efficiently submit their data to regulatory agencies
“Bringing flow-cytometric methodologies into regulatory genetox testing is something we’re seeing increase in popularity,” comments Dr. Stephen Dertinger, Director Research at Litron Laboratories. “The ability to collect many thousands of data points in just a few minutes has significant time savings compared to traditional, microscopic analysis. Study management of all these data is critical.”
Gregor Grant, Executive Vice President Preclinical Solutions, Instem, said: “We are delighted to see an increasing number of clients recognizing the potential of Cyto Study Manager to deliver dramatic efficiency gains in their genetic toxicology operations. Cyto Study Manager is an extremely flexible solution that can be easily customized to meet our clients’ individual genetox workflows.”
About Cyto Study Manager
Cyto Study Manager, originally developed by Perceptive Instruments and now part of the Instem solution portfolio, integrates genetox data acquisition, auditing, reporting and study management into a single system. This GLP compliant solution is revolutionizing genetox study workflows, and leading R&D organizations across the globe are deploying Cyto Study Manager to help them streamline genetic toxicology operations, reduce costs, increase efficiencies and improve regulatory compliance.
Learn more at instem.com or download a Case Study – Leading EU Pharma Company Revolutionizes Genetox Study Workflow with Cyto Study Manager
Litron’s In Vivo MicroFlow kits use flow cytometry to measure a type of chromosome damage known as a micronucleus event. Micronuclei occur in immature red blood cells when chromosomal loss or breakage leads to displaced chromatin, thereby creating a second nucleus (micronucleus). OECD Test Guideline 474 requires that a variety of new compounds be evaluated for their ability to induce micronuclei events in order to keep dangerous products off the market. Importantly, each kit also contains a calibration standard to ensure reproducible results, day-to-day and lab-to-lab. With these benefits, scientists are able to complete more studies in less time.
Data generated by MicroFlow meet global regulatory requirements and are accepted by both domestic and international regulatory agencies.
About Litron Laboratories
Litron has a vision to transform the genetic toxicology industry with a variety of research kits and services based on high-speed flow cytometry. Litron scientists have developed flow cytometric research kits for in vivo and in vitro micronucleus (MicroFlow), in vivo and in vitro gene mutation (MutaFlow Pig-a) and most recently a suite of high-content in vitro screening kits (MultiFlow).
At Litron, we like to stay close to our clients and collaboration is important to us. We want our customers to have the ability to interact with the same scientists who developed these advanced research kits. Litron routinely provides these services to pharmaceutical, medical device, government and contract research organizations around the world.
In this way, Litron is transforming the genetic toxicology industry one test at a time.
Visit LitronLabs.com for more information.
Instem is a global provider of leading software solutions and services that are helping over 500 clients bring their life enhancing products to market faster. We enable clients in the life sciences to more efficiently collect, analyze, report and submit high quality regulatory data, while maintaining compliance for their products around the world.
Instem solutions are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making, leading to safer, more effective products.
Instem supports its global roster of clients through offices in the United States, United Kingdom, France, Japan, China and India.