Diagnostic RT-PCR Instrument and Genetic Analyzer Launched

A fast real-time polymerase chain reaction (RT-PCR) instrument and a genetic analyzer are now available in Japan for in vitro diagnostic (IVD) use.

The 7500 Dx fast RT-PCR instrument and 3500 Dx genetic analyzer were filed as diagnostic application instruments to the Tokyo Metropolitan Government (Japan) in March. The instruments were approved for use as IVDs in Japan. The 7500 Dx and 3500 Dx platforms are already widely available in many countries in Asia, North America, and Europe.

Clinical laboratories and institutions in Japan that develop in vitro molecular diagnostic assays in oncology, genetic disease and infectious disease, will be able to leverage the 7500 Fast Dx system's regulatory clearance to develop tests for clinical applications. The 7500 enables labs to complete real-time PCR amplification and accurately and precisely quantify nucleic acids in less than 40 minutes. The instrument's software suite includes customizable security settings and versatile security, auditing, and e-signature applications that allow users to record all instrument operations, supporting requirements of clinical laboratories to work in a secure environment.

The 3500 Dx series genetic analyzer is the first CE IVD-marked capillary electrophoresis system for nucleic acid analysis. It is intended for use in the analysis of human DNA or RNA for the detection of genetic changes that may lead to disease presence or susceptibility. The series enables scientists to run up to 1,100 sequencing or 1,200 genotyping samples per day. It features a novel consumables design that incorporates the ability to track key information with radio frequency identification (RFID) tags, new optical and thermal sub-systems, and redesigned data collection and analysis software, creating a more cost-effective method for high-quality data analyses.

Life Technologies Japan (Tokyo, Japan) introduced these diagnostics platforms with their easy-to-use, clinically compliant interfaces in Japan. The company is a subsidiary of Life Technologies Corporation (Carlsbad, CA, USA).

Joydeep Goswami head of Life Technologies Japan said, "These devices will enable physicians and laboratories to rapidly develop new clinical and diagnostic assays using a platform they are familiar with. We will work closely with the developers of these assays to assist them in bringing their assays to patients quickly and safely."

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Life Technologies Corporation