Bio-Rad gains marketing clearance from the US FDA for its Medical Decision Support Software (MDSS) designed for use with the company's FDA cleared BioPlex 2200 ANA Screen and BioPlex 2200 system
This interpretive algorithm-based software is the first product of its kind to be FDA-cleared for the purpose of correlating patient antibody results with specific autoimmune diseases.
Using the MDSS with the BioPlex 2200 ANA Screen, autoimmune laboratories will now be able to provide physicians with valuable information on possible disease associations for patient antibody profiles - information that has never before been available through a clinical diagnostic system.
"We have been working very closely with the FDA and we are extremely pleased to receive clearance for the BioPlex 2200 ANA Screen and MDSS," said John Goetz, vice president of Bio-Rad's clinical diagnostics group.
"This unique collection of products will help clinical laboratories improve their autoimmune testing processes and further enhance the quality of service they provide to doctors and patients." Bio-Rad's BioPlex 2200 system is the first and only fully-automated, random access multiplex testing system available today, providing clinical laboratories with the technology to rapidly process, or 'multiplex' multiple individual tests, traditionally processed separately, using a single small volume patient sample.
The system is capable of generating up to 1200 autoimmune test results per hour.
Also in development are additional panels for autoimmune and infectious disease, cardiac disease and diabetes.
