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Beckman Coulter’s NexGen Buy Is Latest Step In New MDx Platform Development

This story originally appeared in Biocommerce Week, a newsletter that has been discontinued.
 
Adding to its molecular diagnostics development efforts, Beckman Coulter said last week that it has agreed to buy the remaining 80.1 percent of NexGen Diagnostics, a spin-out of Lumigen, that it did not already own.
 
The firm has been building a molecular diagnostics presence since the launch of its Vidiera instrument line in 2005. The acquisition of NexGen will provide Beckman Coulter with a sample preparation technology that it believes will help speed test time and will likely be incorporated into its next-generation molecular diagnostics platform that is currently in development.
 
Beckman Coulter bought Lumigen, which makes detection chemistries for clinical diagnostics and life science research, in late 2006 for $185 million. At the time, it purchased a 19.9 percent stake in NexGen, which owns intellectual property that Beckman hopes to use for immunoassay and nucleic acid-based diagnostic testing.
 
The IP is centered on a non-separation immunoassay technology that cuts out “time-consuming steps,” Beckman said, adding that it allows “rapid isolation of DNA or RNA from a patient sample without a separate step or reagent.”
 
A Beckman spokesperson told BioCommerce Week via e-mail that the technology “improves the speed and maintains the sensitivity of certain types of immunoassay and molecular diagnostic testing. It will deliver results faster than current technology can.”
 
She said it is too early to tell how much turn-around time the technology will save, but said “it could be very significant.”
 
The spokesperson declined to say why the firm did not purchase NexGen at the same time as Lumigen, but she confirmed that Beckman has been evaluating the NexGen technology during the past year.
 
Financial terms of the acquisition are not being disclosed. But because NexGen’s assets are in the form of intellectual property that will require development, Beckman said it expects to take a charge of around $36 million for in-process R&D after the deal closes in the fourth quarter of 2007.
 
The acquired technology will not be applied to Beckman’s currently marketed immunoassay systems, the spokesperson said. She also said she could not comment at this time as to whether the technology will be used solely in Beckman’s instruments or may be out-licensed to partners.
 
The acquired nucleic acid technology will most likely be applied to a new molecular diagnostics platform, the UniCel DxN, being developed by Beckman and scheduled for commercial launch in 2010.
 
Beckman Coulter initially disclosed its plans to develop the next-generation platform at last year’s Piper Jaffray Conference (see BioCommerce Week 12/6/2006).
 
Robert Raynor, Beckman Coulter’s director of investor relations, told investors and analysts at this year’s Piper Jaffray Health Care Conference in New York last week that the firm will provide an update on Dec. 11 on the development of the molecular diagnostics platform at its annual business review day in New York.
 
“We will be presenting some milestones on where we are with the project, and will give some data on what we’ve been able to accomplish so far,” he said. “We’re going to lay out for you what we see as our initial launch menu for test items.”
 
The firm has yet to confirm what those test items will be, but the spokesperson said this week that the initial menu will focus on infectious diseases.
 
Beckman jumped into the molecular diagnostics market in 2005 when it launched its Vidiera NsP and NsD instruments, which can be purchased separately but were designed to work in concert. The NsP is a sample-prep instrument, while the NsD is the nucleic sample-detection system based on the firm’s capillary electrophoresis technology.
 
While those instruments helped the company enter the molecular diagnostics market, a few key moves over the past few years have provided Beckman Coulter with the technologies it believes are necessary for the new platform.
 
The firm spent $140 million to acquire Agencourt Bioscience in April 2005 (see BioCommerce Week 5/5/2005). That acquisition provided Beckman with Agencourt’s Solid Phase Reversible Immobilization technology, which isolates and purifies DNA and RNA and was developed for sample-preparation processes in both biomedical research and molecular testing.
 
Another step that was important for Beckman’s molecular diagnostics strategy was a settlement early last year with Applied Biosystems over litigation related to DNA sequencing and thermal cycler technologies. As part of that settlement, Applera granted Beckman licenses to its patents for nucleic acid sequencing and real-time PCR thermal cycling for use in the diagnostics market.
 

Beckman followed that agreement two weeks later with a worldwide licensing deal with Roche, which granted Beckman the right to use Roche’s real-time PCR patents in the diagnostics field in exchange for $27.5 million in cash plus royalties (see BioCommerce Week 7/19/2006).

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