Life Technologies’ Prodigy System Secures CE Mark for In Vitro Diagnostic Use

When used in conjunction with other tests, HLA genotyping is one of the many factors clinicians use to assist in determining a potential solid organ donor-patient cross-match.  The approved system consists of the Prodigy instrument and A, B and DR locus-specific typing kits and software.

HLA markers are cell surface proteins that play a key role in regulating the immune system by acting as an alert mechanism when the body is invaded by foreign proteins.  This helps the immune system combat bacteria, parasites and viruses but can also cause the body to reject donated solid organs. 

The Prodigy platform is a push-button, automated system that uses microarray technology to detect and analyze HLA markers.  The automation enables clinical lab technicians to spend less time setting up their tests and more time analyzing results or preparing new samples.  Its automation and high throughput allows for improved efficiencies, higher reproducibility of data and the reduction or elimination of manual errors.

“We are committed to providing clinical laboratories and research facilities with an automated workflow solution for their HLA testing needs, and this approval is a significant milestone toward achieving that goal,” said Jim Janicki, Vice President and General Manager of Invitrogen Transplant Diagnostics for Life Technologies.  “Matching transplantation patients to solid organ donation is a critical step for patient survival and long term health.  The Prodigy Platform enables significant efficiencies and shorter turnaround times to improve on today’s current methods.”