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Life Tech Commercializes Low-cost Digital PCR System; Stem Cell Characterization Assay

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Life Technologies this week announced the commercial availability of a pair of new PCR-related products for molecular biology research.

First, the firm has begun commercial shipments of its QuantStudio 3D Digital PCR system, a chip-based platform that the company is pricing at $39,000 in a bid to drive widespread market adoption of digital PCR applications. In addition, it has launched the TaqMan hPSC Scorecard Panel, a real-time PCR-based stem cell characterization assay that the company developed in collaboration with Harvard University researchers to enable evaluation of pluripotency and trilineage differentiation potential in human embryonic and induced pluripotent stem cell lines.

'Democratizing Digital'

Life Tech first unveiled the QuantStudio 3D in November at the American Society for Human Genetics conference in San Francisco (PCR Insider, 11/8/2012).

The system features a high-density, nanofluidic silicon chip that enables the generation of up to 20,000 data points per experiment, "coverage that satisfies the needs for most digital PCR applications today," the company said in a statement.

This architecture is more akin to that of early digital PCR player and Life Tech competitor Fluidigm, and stands in sharp contrast to the droplet-based digital PCR platforms offered by Bio-Rad and RainDance Technologies.

By comparison, Bio-Rad's QX100 Droplet Digital system generates 20,000 data points for each sample by using nanoliter-scale droplets; and RainDance's RainDrop Digital PCR system can generate between 1 million and 10 million picoliter-scale reaction volumes per sample. Meantime, Fluidigm last year launched the qdPCR 37K Integrated Fluidic Circuit chip for its BioMark platform, which can create up to 770 reactions for as many as 48 samples for nearly 37,000 total data points, with real-time reaction monitoring.

While Life Tech did not make a direct comparison between the QuantStudio 3D and Fluidigm's platform, it asserted that its new system has several advantages over droplet-based systems. Chief among these is cost — Life Tech said this week that it is pricing QuantStudio 3D at $39,000 — but also a simpler workflow, which it claims reduces the risk of sample contamination and loss of DNA that can occur in droplet-based systems.

According to Life Tech, once a sample has been loaded onto the QuantStudio 3D chip, the system takes less than a minute to return initial data. The platform also has a relatively small footprint of 5 inches wide by 8.5 inches long by 8 inches tall.

"We have democratized digital PCR by introducing a novel instrument and system that simplifies the workflow and enables accessibility by labs of all sizes around the world," Chris Linthwaite, head of genetic analysis at Life Tech, said in a statement.

This week at the European Society of Human Genetics conference in Paris, a pair of early-access QuantStudio 3D customers discussed their work with the platform in a Life Tech-sponsored session. First, Bruno Ping, a senior biomedical scientist at the UK's Royal Surrey County Hospital, shared initial data from his research on Her-2 amplification in breast cancer using formalin-fixed, paraffin-embedded samples. In addition, Erik Springer, a researcher at the Institute of Pathology at the University of Mainz in Germany discussed his work on the detection of BRAF-V600E mutations by comparing data from digital PCR and ARMS-PCR, an ultra-sensitive, sequence-specific PCR technique that enables DNA amplification only when a target allele is contained within a sample.

"Good research depends on three things: researchers' techniques, appropriate funding, and sample quality," Ping said in a statement. "Compared to in situ hybridization methods, digital PCR has a direct impact on these components."

He added that "the great advantage of the QuantStudio 3D is that it makes copy number variation research, for example, more readily available and cost effective as you are able to probe a higher number of samples at lower price points. The data achieved in my lab correlate well with our previous results."

The QuantStudio 3D complements Life Tech's QuantStudio 12K Flex Real-Time PCR system, an "all-in-one" system that the company launched last year and that allows users to perform both low- and high-throughput quantitative and digital PCR experiments on the same sample using the same software interface.

Concurrent to the QuantStudio 3D launch in November, Life Tech also said that it had established a Center for Integrated Genomics at its Foster City, Calif., location, and that the center would dole out grants for up to 20 research projects exploring new uses for the platform.

A Life Tech spokesperson said this week that the grant program is ongoing and the company is still accepting applications. Royal Surrey County Hospital's Ping is the first grant winner. Other winners will be selected before a grand prize winner will be chosen to receive a QuantStudio 3D instrument, the spokesperson said.

Evaluating Stem Cells

On the assay front, Life Tech this week announced the commercial availability of its TaqMan hPSC Scorecard Panel at the International Society for Stem Cell Research conference in Boston.

The genesis of this panel was a collaboration with the laboratory of Alex Meissner, an associate professor of stem cell and regenerative biology at Harvard.

In March, Life Tech said that it had signed a collaborative and licensing agreement with Harvard to further develop the assay panel, which is designed to rapidly evaluate human induced pluripotent stem cells for their use in a variety of discovery and translational research applications (PCR Insider, 3/7/2013).

Until now, scientists have evaluated pluripotency — the potential for ES and iPS cells to differentiate into any cell type — with "laborious, costly, and non-standardized methods that provide ambiguous results," Life Tech said in a statement this week.

Additionally, the company said, previous methods have generally been unable to accurately determine cell lines' propensity to differentiate into one of the three primary cell germ layers — trilineage differentiation — which has helped impede stem cell technology from moving into the clinic.

The TaqMan hPSC Scorecard Panel relies on a specific range of gene expression levels identified in Meissner's lab — work that was published in 2011 in Cell — to accurately characterize cell lines' pluripotency and lineage bias.

"The rapid advancements in stem cell research over the last few years have created a need for more effective and standardized methods for characterizing pluripotent cells," Meissner said in a statement provided by Life Tech. "Today, the field of genomics is helping to meet that demand through development of novel approaches that can help deliver the promise of stem cells."

Standardizing characterization allows researchers to work more efficiently by enabling them to quickly identify the most promising cells, Life Tech said. It also helps accelerate various applications, including development of so-called "disease-in-a-dish" models from patient-derived cells, drug screening, and eventual use of pluripotent cells as a renewable source for transplantation medicine, the company asserted.

Life Tech said in March that the assay panel would be offered on its PCR-based genetic analysis and semiconductor sequencing platforms. The sequencing-based stem cell assay is apparently still under development.

The company said this week that it was offering the TaqMan hPSC Scorecard Panel with cloud-based software for rapid data analysis and data sharing among research collaborators.

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