Promega Maxwell 16 in vitro diagnostics system gains EU approval

2 April 2010

The Promega Maxwell 16 IVD System has gained the CE marked for in vitro diagnostic medical devices. The CE mark applies to the instrument, the Maxwell 16 Blood DNA Purification System and the Maxwell 16 Viral Total Nucleic Acid Purification System.

The bench top automation system is fully compliant with the IVD Directive and supports European clinical laboratories performing diagnostic tests in molecular pathology, transplant HLA, and infectious disease.

The Maxwell 16 IVD System works to the specific needs of a clinical lab. Addressing the pressure to deliver quick results, especially in the process to determine organ compatibility or to diagnose infectious disease, Maxwell extracts multiple samples faster than manual methods. Up to 16 samples can be purified simultaneously, without user intervention and with higher yield and greater consistency.

The unique design of Maxwell 16 prevents cross contamination. It includes integrated barcode reading to help reduce transcription errors, a UV lamp to assist in sanitization of the unit and its compact enough to operate inside a bio-safety cabinet.

"Enabling technologies like the Maxwell 16 can make a meaningful difference in clinical labs that face the accelerated demands of healthcare," explains Ashley Anderson M.D., Promega Chief Medical Officer, "Labs have told us repeatedly how quickly and accurately they can deliver life-saving information and how easy it is to train new technicians. For some it's actually advanced the services they offer."

The new Maxwell 16 IVD System extracts DNA from whole or fractionated blood using the Maxwell 16 Blood DNA Purification System, or viral nucleic acid from plasma or serum samples using the Maxwell 16 Viral Total Nucleic Acid Purification System. The extracted nucleic acids are then used in standard amplification-based diagnostic assays conducted by European clinical labs. The system is fully integrated with pre-filled instrument cartridges and pre-programmed protocols.

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