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Roche Sees Molecular Dx Potential for 454's Sequencer, But Will Follow Customers' Lead

This story originally appeared in Biocommerce Week, a newsletter that has been discontinued.
Roche last week acquired 454 Life Sciences, and the diagnostics potential of the company’s sequencing technology could influence Roche’s strategy going forward, though not likely in the near-term, a Roche official said this week.
Manfred Baier, head of Roche Applied Science, offered few clues about how the company would push 454’s instrument into the molecular diagnostics market. But he said the firm would let customers dictate how the sequencer is used.
Roche said last week that it would acquire 454 in a deal valued at $154.9 million. It has been the exclusive distributor of 454’s Genome Sequencer since October 2005. However, under the terms of the partnership, Roche did not have rights to sell the technology for regulated diagnostic applications — a condition which no longer applies.
According to Baier, Roche would have been content continuing as 454’s marketing and distribution partner, but CuraGen’s announcement in July that it planned to divest 454 forced Roche’s hand. He also said that Roche was not the only firm CuraGen had contacted regarding a possible sale of 454.
“As we really wanted to enter a long-term relationship and develop a long-term investment into sequencing, we finally concluded that under these given circumstances, it is the right thing to do the next step,” and acquire 454, he said.
Following Customers into Dx
While other next-generation sequencing firms, particularly Illumina and Helicos BioSciences, have said they expect their instruments to be used for molecular diagnostic purposes, Baier said the firm would “follow the customers” into whatever applications for which they decide to use the technology, including diagnostics.
“We certainly have no legal limitations to enter any field of application which the customer requires and desires to use sequencing technology,” said Baier. He said the firm “will continue to support our customers in applying this technology into their analytical questions which they want to resolve.”
He noted that there are “a number of clinical studies going on to test to which extent sequencing provides a better answer, or a more precise, sensitive answer in different areas of diseases,” such as HIV and other viruses and oncology.
At the recent Advances in Genome Biology and Technology Conference, researchers from Yale University and Myriad Genetics presented results of separate studies using the 454 sequencer for diagnostic purposes. Yale’s study focused on discovering low-level drug resistance mutations in HIV and potentially using the sequencing technology to predict treatment outcome. The Myriad study evaluated 454’s Genome Sequencer FLX for determining a predisposition to genetic disease.
“We will continue to do what we have done in the past two years, to on the one side make these products — the sequencing technology — as convenient as possible, and on the other side, to support the users in medical research as much as we can in order to let the technology migrate into diagnostics applications,” Baier told BioCommerce Week and sister publication In Sequence.
“When that will happen, nobody knows,” he said. “To what extent that happens, I guess also nobody knows, including the experts, but we follow our customers and will support them.”
Roche is known as the dominant player in the molecular diagnostics market. The firm recently said that its molecular diagnostics division generated 2006 revenue of $975.9 million. Though Baier would not comment on Roche’s plans for the 454 technology in molecular diagnostics, some of the firms developing and selling other next-generation sequencing platforms are hoping the industry adopts the instruments for diagnostic applications.

“We will continue to do what we have done in the past two years, to on the one side make these products — the sequencing technology — as convenient as possible, and on the other side, to support the users in medical research as much as we can in order to let the technology migrate into diagnostics applications.”

454 rival Solexa, which was recently acquired by Illumina in a $615 million deal, certainly sees a future in the $2 billion molecular diagnostics market. In a late November conference call, Illumina President and CEO Jay Flatley said that Solexa’s technology could greatly enhance Illumina’s ability to grow sales in the market, which is expected to double by 2010 (see BioCommerce Week 11/21/2006).
Illumina is hoping that Solexa’s platform will uncover SNPs and other biomarkers that could be used in diagnostic panels on the firm’s BeadXpress system, which was launched a couple of weeks ago.
“One exciting aspect of this merger is the fact that much of the content will wind up in diagnostics,” said Flatley during the call. “Ultimately we can deploy marker sets on either platform.”
Helicos, another next-generation sequencing firm that recently filed for an initial public offering, also has designs on the molecular diagnostics market. The firm is scheduled to debut its HeliScope DNA sequencer in late summer. While its immediate market is the academic and pharmaceutical research markets, Helicos President and CEO Stan Lapidus said earlier this year that “the largest application may well be in diagnostics.”
Another 454 rival, Agencourt Personal Genomics, was purchased by Applied Biosystems for $120 million last year (see BioCommerce Week 5/31/2006).
What role APG’s technology will play in ABI’s molecular diagnostics strategy remains to be seen. ABI officials have said they intend to compete in the molecular diagnostics market — and the firm has a variety of tools at its disposal that could be adapted to the diagnostics field — but they have yet to detail their plans.

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