Medical technology developer Atomo Diagnostics and diagnostic company BBI Solutions have entered into an agreement to commercialize Atomo’s integrated rapid blood test platform, AtomoRapid.
AtomoRapid is a hand-held rapid blood test device that, its makers say, simplifies procedures, eliminating the need for complex test kits containing multiple items. They say it addresses a number of performance issues common to current test kits by providing significant improvements in ease of use and accuracy and is ideal for medical practitioners to use in multiple settings, facilitating point of care testing and the detection of a range of diseases in doctors’ offices, outreach clinics, and patients’ homes.
According to a company spokesperson, AtomoRapid is ISO 13485 compliant. Its development has been structured so as to meet FDA requirements, with particular emphasis on its Human Factors guidelines. The lancing system used in the device meets United States needlestick prevention guidelines. Atomo expects to secure CLIA (Clinical Laboratory Improvement Amendments) waiver status for tests commercialized on the platform. Visitors to this year’s AACC Expo will be able to get hands on with the technology at the BBI Solutions booth #3363.
Part of Alere, BBI is a supplier of diagnostic assay development and manufacturing products, critical reagents, and technologies to the global diagnostic and pharmaceutical markets. Atomo Diagnostics is an Australia-based company with a range of integrated and award winning products that improve usability and performance of blood-based diagnostic testing. Learn more about Atomo Diagnostics and BBI Solutions.