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Qiagen Says Expanded PCR IP Portfolio Will Boost Hardware and Consumables Sales, Drive Entry into IVD Market

NEW YORK (GenomeWeb News) – Qiagen's acquisition last week of additional PCR licenses from Roche and Idaho Technology will bolster the company's PCR business on several fronts, including hardware, consumables, and in vitro diagnostics, according to a company official.

In addition, the company has further expanded its PCR offerings through its acquisition this week of DxS. The Manchester-UK-based firm sells several RT-PCR assays as well as the Scorpions PCR technology, which DxS claims is particularly well suited for molecular diagnostics.

Last week, Qiagen announced that it had expanded its existing license agreements with Roche and IDT to cover a broad swath of the PCR market. The new agreements not only allow the firm to sell its Rotor-Gene Q thermal cycler and reagents for both research and diagnostic applications, but also extend to high-resolution melting curve analysis, or HRM technology — a key component in the company's strategy for increasing its foothold in the PCR market.

Qiagen already held a number of key licenses related to PCR instrumentation and reagents, Achim Ribbe, executive director of business development for Qiagen, told GenomeWeb Daily News. "What was missing was basically the rights to make use of this IP in order to manufacture, sell, and market consumable products such as HRM PCR kits to be used in conjunction with the Rotor-Gene Q instrumentation platform for all markets and applications, including the IVD market."

Ribbe said that while the company will continue to develop HRM reagents and other qPCR reagents for all third-party thermal cyclers, it believes that the Rotor-Gene Q, which it gained through its acquisition of Corbett Life Science last year, is particularly well suited for the approach.

HRM is a post-PCR analysis step that characterizes PCR products based on their melting behavior. It can differentiate products based on sequence, length, GC content, or strand complementarity, and is able to capture differences at single-base resolution. The approach is particularly useful for genotyping, mutation scanning, and methylation analysis.

Ribbe noted that in order to perform HRM effectively, "you need an instrument that is capable of controlling and monitoring temperature and fluorescence very precisely, as well as powerful software to analyze the data." He added that the company expects HRM users to "particularly benefit from the highest well-to-well temperature uniformity available on the Rotor-Gene Q."

Qiagen believes that the Rotor-Gene is the ideal platform for HRM because its rotary design spins each tube in a chamber of moving air to provide greater temperature control than so-called "block" cyclers. Well-to-well variation in the Rotor-Gene is generally less than 0.01 degree Celsius, which is 20 times less than block cyclers, according to company literature.

As a result, Ribbe said, the new IP agreements were "a perfect match for us — having those extended by high-resolution consumable rights and certain associated Rotor-Gene Q instrumentation IVD rights, while having the perfect platform to leverage these additional rights."

Ribbe said that HRM is primarily of interest in the research market now, "but it's emerging now more into the diagnostic market."

He noted that the company is currently in the process of getting the Rotor-Gene CE-marked, "and later on certainly at some point we would like to move HRM into the IVD market."

Ribbe said that a "wide range" of the company's Artus assays already have CE-IVD approval on the Rotor-Gene Q, and Qiagen expects the cycler itself to be CE-IVD marked "very shortly."

In 2010, the company intends to submit several assays to the US Food and Drug Administration for approval on the instrument, he added, but did not elaborate.

In addition, Ribbe said, DxS offers a range of RT-PCR assays that are "strongly suitable" for use with Qiagen's instruments, including the Rotor-Gene Q.

The Scorpions technology from DxS also is expected to benefit Qiagen's molecular diagnostics effort. The technology offers very high sensitivity and specificity, Ribbe said, enabling the detection of very few target molecules and single-nucleotide changes. "An additional benefit of the technology is the speed of reaction, which is widely recognized as the fastest in its class, with detection reaction times of less than ten minutes," he said.

Qiagen has already launched two HRM kits that are optimized for the Rotor-Gene Q but can also be used with third-party cyclers: Type-It HRM for genotyping applications; and EpiTect HRM for methylation analysis. The new agreements with Roche and IDT will allow the company to expand this reagent portfolio as well as its HRM software suite.

Ribbe said that Qiagen views its assay development expertise — particularly its ability to adopt reagents to instrumentation platforms — as a competitive advantage in the PCR marketplace. In addition, the firm has identified the HRM segment as one of the key growth areas for its PCR business. He cited an internal survey of the qPCR market that found that more than 60 percent of respondents were "interested" in HRM applications.

"It's an emerging technology that is an extremely attractive method for genotyping and it's picking up nicely," he said. "We think that having a superior complete solution for leveraging high-resolution melting is a nice growth opportunity for us."

He added that with the new licensing agreements, Qiagen has essentially filled in all the remaining gaps in its PCR IP portfolio. "We have a unique position," he said. "Including our own PCR-related IP portfolio, I'd have a hard time thinking of any other companies out there that have as much hardware, software, and consumable-related PCR rights as we do."

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