Product News: Life Technologies Announces Regulatory Approval of its 3500 Dx Series Genetic Analyzers in Canada

24 May 2013

Life Technologies Corporation has announced that its Applied Biosystems™ 3500 Dx /3500 xL Dx Genetic Analyzers CS2 have been approved by Health Canada for diagnostic use. The development marks a major extension of Life Technologies' capabilities to serve the clinical end market in North America with Sanger-based solutions.
The Applied Biosystems™ 3500 Dx Series Genetic Analyzers deliver high quality performance, higher throughput and increased productivity for clinical laboratories around the world. The 3500xL Dx is an automated 24 capillary-based Sanger Sequencer; the 3500 Dx is an eight capillary instrument.

Together, the offering of both 3500 Dx and 3500xL Dx provides hospitals of all sizes the flexibility they need to meet their unique throughput demands designed for a wide range of sequencing applications. In addition to diagnostic use, the instruments are appropriate for a wide range of research applications, including de novo sequencing and mutational profiling.

"The current approval of the 3500 Dx Series Genetic Analyzers by Health Canada emphasizes Life Technologies' success in pursuing regulatory pathways for our diagnostics laboratory instruments, as well as our vision to becoming a global leader in the molecular diagnostics industry," said Ronnie Andrews, president of Medical Sciences at Life Technologies.

Applied Biosystems Sanger Sequencers supplied the technology that powered the Human Genome Project, and Sanger instruments remain the sequencing "gold-standard" for accuracy, reliability and ease of use. The participation of the sequencing technologies in clinical diagnostics is reshaping the disease treatment paradigm worldwide.

In February 2013, the 3500 Dx/3500xL Dx Genetic Analyzers CS2 Series received U.S. Food and Drug Administration (FDA) 510(k) clearance for use with the company's SeCore® HLA typing kits. Additional products offered by Life Technologies for the molecular diagnostics lab market in Canada include the Applied Biosystems™ 7500 Fast Dx Real-time PCR instrument and the QuantStudio™ Dx Real-time PCR Instrument, both available as Class I devices.