FRANKLIN LAKES, N.J. - BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, 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 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.'
About the BD Kiestra laboratory automation solutions
BD Kiestra lab automation solutions provide total lab automation for the clinical microbiology laboratory. These solutions are designed to enhance laboratory operations, increase financial efficiencies, and advance laboratory operations. BD Kiestra lab automation offerings include scalable and modular microbiology workflow automation solutions, ranging from standalone units to fully automated track-based automation systems for mid- and high-volume labs.
About BD Synapsys
BD Synapsys Informatics solution enables laboratories to address challenges and improve laboratory outcomes. It allows labs to analyze their performance using enhanced microbiology informatics through a single, advanced platform with an intuitive, personalized user interface. BD Synapsys Informatics solution offers integrated workflow and on-demand insights to empower laboratory staff to impact turnaround time, expedite decision-making, improve productivity, and support their compliance requirements. BD Synapsys Informatics was among the first life science diagnostics informatics platforms to receive the Underwriters Laboratory Cybersecurity Assurance Program certification, an independent third-party evaluation that uses standardized, testable criteria for assessing software vulnerabilities and weaknesses
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
Mela Sera, APR
BD Public Relations
Head of Investor Relations