BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD Kiestra™ IdentifA system, which is designed to automate the preparation of microbiology bacterial identification testing.
Identifying the microorganism that is causing an infection is a labor-intensive process. With the BD Kiestra™ IdentifA, the lab technician uses BD Synapsys™ informatics to select discrete bacterial colonies from a digital plate image. Sophisticated robotics then physically pick those selected organisms and prepare the sample for specific identification testing. By automating what are typically cumbersome manual steps, the BD Kiestra™ IdentifA may reduce the potential for human error when preparing samples for bacterial identification and produce more accurate diagnoses for patients. Streamlining processes also enables lab technicians to focus their time and expertise on higher-value tasks.
“BD continues to invest in automation and innovation for the microbiology laboratory to enable smart, connected, end-to-end workflows designed to accelerate insights and efficiency,” said Brooke Story, president of Integrated Diagnostic Solutions for BD. “Our ‘discovery to diagnostics’ strategy positions us to provide best-in-class solutions at every point along this continuum.”
BD Kiestra™ IdentifA is the only FDA-cleared solution that is available as part of a track-connected system for lab automation to support specimen preparation workflows for routine and challenging isolate types. The integration of the BD Synapsys™ Informatics solution with the BD Kiestra™ IdentifA, in combination with matrix-assisted laser desorption/ionization-time of flight (MALDI-ToF) mass spectrometry, can yield more rapid and accurate identification of bacteria and yeasts to aid clinician treatment decisions.
“The BD Kiestra™ IdentifA system transforms the manual workflow into one that is standardized, automated and digitized,” said Greg Miziolek, vice president and general manager of the U.S. region for BD Integrated Diagnostic Solutions. “Mass spectrometry methods, including MALDI-ToF technology, have innovated and advanced microbial identification in clinical microbiology but often require a significant number of process steps and hands-on-time. The BD Kiestra™ IdentifA system uses automated colony picking and MALDI-ToF spotting to reduce time to pathogen identification, which in turn can help improve patient management.”