Life Technologies has received CE IVD marking for its Applied Biosystems QuantStudio Dx platform and launched the instrument in Europe.
In addition, Life Tech is introducing for use on the platform a CE marked Clostridium difficile assay, developed with partner Quidel, and said that the companies plan to introduce assays for several other infectious diseases in 2013.
The QuantStudio Dx is an in vitro diagnostic version of Life Tech's QuantStudio 12K Flex instrument, which the company launched for research use only in October 2011 (PCR Insider, 10/31/2011).
The two platforms have more similarities than differences, but the QuantStudio Dx has several distinct features that make it more amenable to developing and running in vitro diagnostic tests based on real-time PCR.
"In brief, the RUO model offers maximum flexibility that researchers want, whereas the Dx model is focused to the specific needs of diagnostic laboratories," a Life Tech spokesperson told PCR Insider in an email.
Perhaps the biggest difference between the systems is that the QuantStudio 12K Flex is capable of running real-time PCR in nearly any consumable format, including digital PCR. The Flex accepts five interchangeable blocks, from 96-well plates to the OpenArray format with about 12,000 data points per run.
The QuantStudio Dx, on the other hand, accommodates 96- or 384-well plates, "which are typical for diagnostic runs," as well as qPCR microfluidic cards, which can perform 48 tests on eight samples simultaneously, the company said.
In addition, the Dx version has several features to make it easier to use, including touch screen operation, reagent and sample tracking, and LIMS interface; and "sample loading options were simplified and optimized for the clinical lab customer," the spokesperson said.
Two software options are available: QuantStudio Dx software, which runs IVD tests in a secure mode with pre-set run and analysis parameters; and QuantStudio Test Development software, which enables the development of custom tests and supports clinical research projects.
Life Tech noted that customers can use its 8-by-48 microfluidic cards to design and implement custom molecular diagnostic assays, and that Life Tech is currently using the format to develop diagnostic tests in house.
In general, the platform can perform a variety of diagnostic applications, including pathogen detection, gene expression analysis, SNP genotyping, copy number analysis, mutation detection, microRNA and other non-coding RNA analysis, and high-resolution melt analysis.
"We recognize that clinical laboratories have multiple needs," Ronnie Andrews, president of medical sciences at Life Tech, said in a statement. "Accuracy and reliability are paramount when running diagnostic tests for physician reporting. In addition, medical research labs need instrumentation that supports experimental work. The QuantStudio Dx instrument addresses both these needs."
News of the QuantStudio Dx's development first leaked in July, with the company advertising that it would offer a preview of the platform to attendees of July's American Association of Clinical Chemistry in Los Angeles (PCR Insider, 7/26/2012).
Around that time, clinical diagnostics firm Quidel disclosed in an earnings call that it had signed an agreement with Life Tech to develop and commercialize real-time PCR assays for the QuantStudio Dx. The companies already had an agreement in place under which Life Tech is marketing Quidel's PCR-based assays for use on the ABI 7500 system in Europe.
Life Tech said this week that the QuantStudio Dx platform would launch in Europe with the Quidel Molecular Assay for C. difficile, with Life Tech serving as distributor of the test.
More Quidel tests for the QuantStudio Dx are currently under development and will be available in 2013. These include assays for influenza A and B, human metapneumovirus and respiratory syncytial virus, herpes simplex virus 1 and 2, and varicella zoster virus.
Life Tech said that it plans to submit the QuantStudio Dx for 510(k) clearance to the US Food and Drug Administration in December.