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Life Tech Taps Persistent to Prep CE Sequencing Software for Clinical Use

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By Uduak Grace Thomas

As Life Technologies prepares its 3500 Dx capillary electrophoresis sequencing system for clinical use, the company is partnering with Pune, India-based Persistent Systems to rebuild the system's software to meet US Food and Drug Administration Agency's regulatory requirements.

Speaking to BioInform this week, Aditya Phatak, head of Persistent's US Life Sciences Business, said Persistent sees the Life Tech deal as an opportunity to expand its footprint in the personalized-medicine market by creating infrastructure and providing services that are needed in the space.

Specifically, Persistent will work with Life Tech to redesign the DNA-sequencing software and the fragment analysis software for the 3500 Dx genetic analyzer, and provide services to integrate third-party vendor assays into the platform.

Life Tech said it plans to submit the system for 510(k) clearance in the third quarter of this year.

Peter Christey, senior director of Life Technologies’ fragment and sequence genomics arm, said the company tapped Persistent as its development partner because the company developed software for the CE system in the past.

He said the current effort with Persistent will support "our diagnostic assay partners as they develop molecular diagnostic products for the 3500 Dx platform."

The system, which Life Tech launched last year, has so far gained CE-IVD marking for diagnostic use in several EU countries and is approval for clinical use in Asia, Australia, and New Zealand.

In March, with an eye toward obtaining 510(k) approval, Life Tech announced that it had begun clinical trials in the US to prove the 3500 Dx is safe and efficacious for clinical use (CSN 03/22/2011).

With that goal in mind, Life Tech began working with diagnostic developer Gen-Probe to obtain FDA clearance for its transplant diagnostic and other assays that will be run on the 3500 Dx (CSN 05/24/2011). Christey said the firm is still seeking additional diagnostic assay partners for the platform.

Now, with Persistent's help, Life Tech is readying its CE software to clear US regulatory requirements as well.

Persistent's developers will work with Life Tech's fragment and sequence-genomics division, investing financially as well as providing technology expertise and support to rebuild the platform with applications that are suited for use in clinical and medical diagnostics settings, Phatak said.

In terms of specific development goals, he explained that the partners will focus on creating a simpler user interface for the software that will include workflows that are specific for diagnostic labs. They will also aim to improve the accuracy of the instrument.

Persistent will also develop application programming interfaces that will allow users to integrate third-party assays into the platform.

The partners hope to have the software compliant in the next 18 to 24 months, Phatak said.

Furthermore, under the terms of the agreement, Persistent will be the exclusive provider of assay integration services for the platform — a deal that Phatak said is expected to be a "significant" source of revenue for his company over the next few years, though he declined to provide specific revenue projections.

He pointed out that while capillary-based technologies have been largely replaced by next-generation sequencers they still hold a large portion of the clinical market due to their lower cost and better accuracy. He estimated that Life Technologies controls of about 85 percent of the CE market.

Christey noted that”capillary electrophoresis remains the gold standard sequencing platform" and Life Tech believes it will "play a major role in clinical diagnostics."


Have topics you'd like to see covered in BioInform? Contact the editor at uthomas [at] genomeweb [.] com.

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