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As Invitrogen Pens Biomarker Pact, Downstream Objectives Take Shape

As Invitrogen starts to focus on its recently announced collaboration with the Fred Hutchinson Cancer Research Center, its second biomarker pact within the past year with a major cancer center, the firm has taken one step closer to entering the molecular diagnostics and pharmacogenomic markets and adopting what one official calls a "patient-centric" view.

The two alliances, and the recent creation of a chief medical officer position, clearly signal Invitrogen's intent to move its technologies to applications that are closer to the patient. In addition, the collaborations might provide the firm with an advantage over competitors developing molecular diagnostic products for cancer.

"In the broadest sense, our interest is to get closer to the patient, to utilize our technology for more direct medical applications," David Odelson, Invitrogen's director of corporate development, told BioCommerce Week via e-mail.

The firm is being tight-lipped about the details of the agreements and the ultimate application of technologies that may result from them. When asked if the firm was planning on developing and selling pharmacogenomic assays based on its partnerships with the Mayo Clinic and Fred Hutchinson, Odelson declined to comment.


"In the broadest sense, our interest is to get closer to the patient, to utilize our technology for more direct medical applications."

The collaboration with Fred Hutchinson centers on the use of Invitrogen's ProtoArray microarrays in developing cancer diagnostic and screening tools. In return, Invitrogen would have rights to license technologies that result from the collaboration.

The deal follows an earlier pact with the Mayo Clinic, under which Invitrogen is providing financial and research support for discovering biomarkers for prostate, breast, lung, and colon cancer. The firm has an option to license resulting technologies from that collaboration on an exclusive and non-exclusive basis.

Odelson said that although the new agreement is similar to the one signed with the Mayo Clinic, "the specific program is different." He added, "The applications of biomarkers in this program is as important as the discovery in this program," but declined to be more specific.

The Mayo pact, initiated last December, marked Invitrogen's initial foray into the molecular diagnostics market, and was its first alliance with a large-scale research institution (see BioCommerce Week 12/9/2004). Odelson said that the collaboration with the Mayo Clinic has yielded several discoveries already, but he did not elaborate.

Patient-Centric Focus

Claude Benchimol, Invitrogen's senior vice president of research and development, said that the firm was seeking to expand its presence in the clinical market — a strategy that included the creation of a corporate research laboratory.

"We want to become more medically relevant and closer to our customers," Benchimol said. "We want to engage in collaboration with academic and research institutions, as well as other customers to help solve big problems."

Part of Invitrogen's plans to shift its focus away from earlier stage research toward more patient-centric research was the creation of a chief medical officer position within the firm. It recently named David Onions, formerly chief scientific officer of its BioReliance unit, to the post. In that role he is expected to coordinate efforts to integrate technologies across all units of the company (see this week's Q&A with Onions).

"My role is to help others focus toward this patient-centric view," Onions told BioCommerce Week.


"We want to become more medically relevant and closer to our customers.
We want to engage in collaboration with academic and research institutions, as well as other customers to help solve big problems."


Invitrogen's strategy has been bolstered by several acquisitions over the past year aimed at increasing its molecular diagnostic and pharmacogenomic capabilities.

The firm's Diagnostic Solutions unit has been building its business off of the acquisitions of Zymed and Dynal (see BioCommerce Week 1/13/2005 and 2/10/2005), which provided the firm with HLA typing and CISH (chromogenic in situ hybridization technology) pathology products. But perhaps most importantly, the Dynal acquisition provided Invitrogen with a magnetic bead technology that the firm expects will work well in molecular diagnostic applications.

Onions said those acquisitions, which also supplied Invitrogen with a suite of antibody tools, were a key part of the firm's plans for the molecular diagnostics market.

There are plans to grow the diagnostics part of the company first as an OEM partner to other diagnostic firms and eventually by selling its own tests, CEO Greg Lucier said during a webcast in June (see $8 million



Zymed




$60 million



Dynal



April 2005


$391 million



Caltag



May 2005


$20 million


Lucier also said, ""Undoubtedly there are technologies we can add to enhance our ability to perform in this business model."" But for now, Invitrogen plans to aggressively pursue deals as an OEM supplier and take market share from the other reagent makers.


Invitrogen will let its larger diagnostic partners handle the regulatory process, while the firm sticks to its role as a supplier, according to Lucier.


The firm also plans additional collaborations on biomarkers, such as the partnership with the Mayo Clinic signed this past December (see BioCommerce Week 12/9/2004), and is negotiating a similar collaboration with a well-known, yet undisclosed, cancer research center. The company expects to announce that deal in the second half of this year.


Another major consideration for the firm in playing in the molecular diagnostics space is its sample-preparation portfolio, and this was the key reason Invitrogen purchased DNA Research Innovations and its ChargeSwitch nucleic acid-purification technology in October. With this technology, the firm is taking aim at competitor Beckman Coulter, which enhanced its own sample-prep abilities with the recent purchase of Agencourt Biosciences (see BioCommerce Week 5/5/2005).


Invitrogen also fired a salvo across the bow of competitors saying that its sample-prep technology can work well on a variety of molecular diagnostic platforms. ""There are a lot of different existing installed base platforms out there right now, and we want to put our chemistries across as many of them as possible, including entrenched competitors who might not necessarily want us to do that,"" Lucier said.


There are also plans in the works to collaborate with an established imaging technologies partner on molecular imaging products, though company officials wouldn't name any potential candidates.


In a somewhat unusual move, Illumina sent a representative to the meeting to provide an update on the oligonucleotide collaboration between Invitrogen and Illumina. The firms reiterated their plan to launch the platform, based on Illumina's Oligator technology, and snatch up market share by providing lower-cost oligos through Invitrogen's expansive customer base (see BioCommerce Week 12/23/2004).


Lucier suggested that the partnership with Illumina could command a 50-percent market share in the next three to four years. The firms will be competing with the likes of IVT, Sigma-Aldrich, and Operon Biotechnologies.


One other noteworthy piece of information that was revealed during the webcast was that Invitrogen is evaluating adding instrumentation to its offerings. During a Q&A session, Shawn Smith, director of Invitrogen's BioProduction unit, said, ""Do we want to have a specific application platform that's automated within our own offering? The answer to that is, 'Yeah.' I think that's inevitable. I think we have to have the ability to offer the complete offering. It's a broader product portfolio than just the chemistries exclusively.""


Company officials declined to elaborate on what kind of instrument that might be.


— Edward Winnick ([email protected])


"/110668-1.html" target="_blank">BioCommerce Week 6/23/2005

). Invitrogen currently has about a dozen salespeople serving the diagnostics market and that will likely increase.

Another major consideration for the firm in playing in the molecular diagnostics space is its sample-preparation portfolio, and this was the key reason Invitrogen purchased DNA Research Innovations and its ChargeSwitch nucleic acid-purification technology in October. With this technology, the firm is taking aim at competitor Beckman Coulter, which enhanced its own sample-prep abilities with the purchase earlier this year of Agencourt Biosciences (see BioCommerce Week 5/5/2005).

— Edward Winnick ([email protected])

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