Promega reports that its Maxwell 16 DNA purification system is now CE marked in accordance with the requirements of Directive 98/79/EC IVD
The new mark particularly helps European clinical laboratories performing tests in molecular pathology and transplant HLA to achieve compliance with IVD directives in their countries.
The new Maxwell 16 system supports DNA-based tests performed on blood and buffy-coat by clinical labs, including sample preparation for human transplantation donor-matching tests carried out by HLA labs.
Currently, labs can face extreme pressure in delivering test results quickly enough to act on the transplant of an organ while it is still viable.
Manual sample extraction methods require hands-on time of 40 minutes or more.
With Maxwell 16, up to 16 DNA samples can be purified simultaneously, without user intervention, in about 30 minutes, with higher yield and more consistency than similar methods.
"Our intent is to support clinical labs in their life-saving work by offering a purification method that handles more samples faster and more accurately than existing manual methods," explains Andy Bertera, Promega vice president of marketing.
"Clinical labs in both Europe and the United States need to have access to affordable automation that meets regulatory requirements and allows them to deliver test results as quickly as possible."
