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.