Over the last 20 years, Litron has developed and patented the MicroFlow technology, a faster and more efficient process for monitoring chromosomal damage.
The U.S. Food and Drug Administration (FDA) requires companies to run a series of tests, or assays, to make sure that a potential new drug is both safe and effective. One of these tests involves monitoring for micronuclei that are created when chromosomes are damaged by the drug, and some of the genetic material breaks off. This type of test, which has been conducted for decades, typically takes a technician 15 to 30 minutes to count 2,000 cells. Litron’s automated MicroFlow method can examine 20,000 cells in minutes. The process also removes any bias that may result from different technicians performing the standard assay.
Since first developing the method, Litron has adapted MicroFlow to improve the technology and overcome many problems. For example, Litron added a reagent to yield better results due to the presence of platelets and recently, a new solution was developed to improve long-term sample stability.
In addition to their pre-clinical work, Litron’s patented technology covers human analyses and has been used in research settings for the past few years. Tthese analyses are an exploratory tool, and are not intended or approved for prognostic or diagnostic use. Litron is currently restructuring its manufacturing processes and collecting data for FDA review. Bemis said that Litron hopes to submit about a year from now.
The full line of MicroFlow products offers companies a number of mature, flexible and comprehensive options that cover a great number of species and cell lines. In Vivo MicroFlow technology can be used in two ways; the first is as a reagent kit for purchase, with enough material to collect and analyze a specific number of samples using a company’s own flow cytometer. Second, MicroFlow can be used as a service where samples are sent to Litron for analyses. In this way, Litron is able to serve companies of all sizes.
The MicroFlow technology can also be employed as an in vitro test, with cells in culture. The in vitro test is typically performed for screening purposes that can be completed quickly in order to sort out what is causing chromosome damage from what does not. There is particular interest surrounding both the in vivo and in vitro tests, since international guidelines for the conduct of these assays are in the process of being developed.
