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For Invitrogen, Prodesse Pact Is Latest Feather In Dx Cap; Additional OEM Deals On the Way

Stepping up its efforts to push products into the burgeoning molecular diagnostics market, Invitrogen last week licensed its Lux reagent technology to Prodesse, a Wisconsin-based developer of multiplex PCR-based diagnostic tests.
 
The alliance is the latest in a series of actions taken by Invitrogen to further develop a variety of technologies acquired during its 2004-2005 buying spree for the molecular diagnostics field. The pact also furthers Invitrogen’s plans to greatly expand its OEM business.
 
“Invitrogen has quite a broad portfolio of reagents that are applicable to the molecular diagnostics area — and this is an area we’re becoming much more aggressive in OEMing and supporting,” said Sallie Cassel, business area manager for gene regulation at Invitrogen. “Presently, Prodesse is just one of a variety of partners that we’re sticking to as far as OEM capabilities in this area.”
 
Under the agreement, Prodesse will use the Lux — or Light Upon eXtension — reagents in developing molecular diagnostic assays that will be used at the firm’s own clinical lab and sold to other labs. Invitrogen officials declined to disclose what applications the assays would target.
 
Tom Shannon, president and CEO of Prodesse, said in a statement, “Now we can provide our customers with a technology that has significant design flexibility as well as the tremendous advantage of conveying service rights that do not carry royalty burdens to end users.” Attempts to reach Shannon for additional comment were unsuccessful.
 
According to Cassel, the collaboration with Prodesse is the first centered on the Lux reagent line, which is a quantitative reverse transcriptase qPCR technology. The reagents are used with the firm’s SuperScript III reverse transcriptase labeling and detection technology and Platinum Tfi DNA polymerase to develop assays in a multiplexed setting.
 
She said that although there are competing technologies that allow multiplexing, among them TaqMan probes and molecular beacons, the Lux technology also “allows you to do melting curves, which give you better specificity.” Melting curve analysis enables a customer to check qPCR reactions for primer-dimer artifacts and contamination and to ensure reaction specificity and accurate quantification.
 
More OEM Deals Expected
 
Building an OEM business has been a focus for Invitrogen as the firm seeks partners and expanded applications for its growing portfolio of reagents — and the collaboration with Prodesse furthers that goal. Last month, Invitrogen made its entry into the next-generation sequencing field with an OEM agreement to supply Solexa with most of the reagents that its as-yet unreleased Genome Analysis System will use for sequencing, gene expression, and small RNA analysis applications (see BioCommerce Week 6/14/2006).
 
At the time of that pact, Lisa Filippone, business area manager for PCR and nucleic acid separation for Invitrogen, told BioCommerce Week that the firm "hope[s] to have more" agreements with next-generation sequencing shops. "We are working on expanding our capabilities and offerings in the OEM space. Growing our OEM business is something that we definitely are interested in doing that could be with other next-generation sequencing companies or any company out there in our space," she said.
 
Cassel said the alliance with Prodesse is the first one Invitrogen is announcing publicly, but, “we have other partnerships that we are discussing that are similar. In some cases, there are partners that we’re talking to where the technologies we’re discussing are slightly different,” she said.
 
For example, “Invitrogen has a broad portfolio of enzymes, many of which are useful in molecular diagnostics, some of which are not part of the Prodesse agreement, but are part of discussions with other partners,” said Cassel.
 
Building the Molecular Dx Portfolio
 
Invitrogen's interest in the molecular diagnostics industry, which is currently valued at roughly $2 billion, has been building over the past couple of years, and the company has made a string of acquisitions to bolster that play. In particular, its purchases of Molecular Probes in 2003 and its acquisitions of Dynal, Caltag, and BioSource last year were made with the molecular diagnostics market in mind.
 

“Invitrogen has quite a broad portfolio of reagents that are applicable to the molecular diagnostics area — and this is an area we’re becoming much more aggressive in OEMing and supporting.”

In total, Invitrogen spent nearly $650 million last year to acquire eight businesses with an eye clearly on applications closer to the patient, primarily molecular diagnostics, as well as building its cell biology and proteomics businesses. That followed $500 million spent on acquisitions the year before.

 
Cassel cited the firm’s chromogenic in situ hybridization (CISH) assays as a prime example of the firm’s growing offerings in the molecular diagnostics space. The assays — which were gained through Invitrogen’s January 2005 acquisition of Zymed Laboratories (see BioCommerce Week 1/13/2005) — employ DNA probes to ascertain the level of gene amplification present in sample cell tissue.
 
Invitrogen is developing CISH kits for Her2, C-Myc, Cyclin D1, EGFR, N-Myc, and Topoisomerase II. Earlier this year, the firm filed for US Food and Drug Administration clearance of the Her2 probes, and a company official said Invitrogen is actively seeking pharmaceutical partners that may be able to use the probes to help select patient populations (see BioCommerce Week 4/19/2006).
 
In addition to the acquisitions, the firm has signed several alliances aimed at developing molecular diagnostic products. The most recent of which is a collaboration announced in April with German firm Signalomics to develop nanocrystal reagents for tumor identification (see BioCommerce Week 4/12/2006).
 
Invitrogen Chairman and CEO Greg Lucier said during an April conference call that company officials expect to provide a timeframe this year on Invitrogen's path to market for diagnostic products (see BioCommerce Week 5/3/2006), but the firm has yet to disclose that timeframe. He noted, in particular, that the goal of a collaboration with the Mayo Clinic, inked in December 2004, was to see how Invitrogen's tools could be applied to molecular diagnostics (see BioCommerce Week 12/9/2004).
 
According to Cassel, it doesn’t matter whether Invitrogen’s partners develop tests for CLIA labs, such as Prodesse, or for FDA clearance. “We have the ability to support both of those areas right now,” she said.
 

Asked whether Invitrogen would develop instruments to work in concert with its molecular diagnostics technologies, Cassel cited previous comments from Lucier that “instrumentation continues to be something that Invitrogen is exploring and interested in. We have what we call some clinical benchtop instruments already, however, we have not yet gone into the larger instruments, such as qPCR machines. But it’s not something I would rule out,” she said.

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