Life Technologies Corp. has introduced
a real-time PCR instrument for the European market. The Applied Biosystems QuantStudio Dx system carries a CE-IVD mark and is designed for pathogen detection, gene expression, SNP genotyping, and other clinical diagnostic applications, according to the company.
With the European launch Life Technologies hopes to tap into the growing market for molecular diagnostic tests, says Ronnie Andrew, president of medical sciences at the company. Life Technologies estimates that the global IVD market of $52 billion will reach $70 billion by 2015. The European IVD market of $14 billion is forecast to grow to $17 billion by the same year, according to the company.
The QuantStudio Dx features interchangeable thermal cycling bocks for 96- or 384-well plates and a proprietary qPCR microfluidics card. The card can perform 48 simultaneous tests on eight samples without the need for liquid-handling robots, according to the company. Two software options are available, and the European instrument is equipped with a Quidel molecular assay for C. difficile from Life Technologies. The company plans to offer an influenza A + B assay, a herpes simplex virus 1 and 2 test, and other Quidel-based infectious disease applications for the instrument in 2013.
Life Technologies says the the QuantStudio Dx will be submitted for FDA 510(k) approval in December 2012.