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Beckman Coulter’s MDx Test Menu Focuses On Infectious Diseases, Oncology, Genomics

This story originally appeared in Biocommerce Week, a newsletter that has been discontinued.
 
Beckman Coulter this week unveiled the planned initial menu of tests to be run on its next-generation diagnostics platform, which is on schedule for launch in 2010.
 
The firm held its annual business review meeting this week in New York and focused almost entirely on its diagnostics business, providing an outline of its pipeline of tests for both its immunoassay and molecular diagnostic instruments. The menu for its molecular diagnostics platform provided little surprise, with a focus on infectious diseases.
 
Beckman Coulter initially disclosed its plans to develop the next-generation platform, now called the UniCel DxN, a year ago. It laid the groundwork for that platform through a series of moves including its $140 million acquisition of Agencourt Bioscience in April 2005, a settlement with Applied Biosystems over thermal cycler patents last year, and a licensing deal with Roche covering real-time PCR patents.
 
Two weeks ago, in another step in its diagnostics development strategy, Beckman agreed to buy the remaining 80.1 percent of NexGen Diagnostics, a spin-out of Lumigen, that it did not already own (see BioCommerce Week 12/5/2007).
 
While the acquisition of NexGen provides Beckman with a sample preparation technology that could reduce test time and will eventually be incorporated into its molecular diagnostics system, it will not initially be part of the UniCel DxN, President and CEO Scott Garrett said during a webcast of the meeting.
 
The NexGen technology is “a true next-generation immunoassay capability that can be applied in lots of ways, and [offers] a way to speed up the very important front end of the molecular process,” said Garrett. However, it is “unlikely to be integrated into our DxN project right away, because we don’t want to do anything that would slow down or delay the launch date on the DxN. It would clearly be an enhancement to the DxN in future years.”
 
Garrett noted that the molecular diagnostics market is currently valued at more than $2 billion and is growing rapidly. “Our strategy in molecular is to bring testing to the routine clinical lab,” he said.
 
The DxN is expected to be a walk-away, fully automated system that will be able to run 20 assays at a time. Garrett said he expects the system to have a moderately complex designation in regard to CLIA, “which means that relatively less skilled operators can run these systems.”
 
Also, the DxN is expected to run up to 200 tests per eight-hour shift and provide results for DNA tests in an hour, and about 90 minutes for RNA-based tests.
 
“We believe these specifications are not currently met by anyone that’s on the market,” said Garrett. “We think that we’ll be among the first to deliver a system that begins to meet any of these requirements.”
 
He said Beckman expects to have a prototype system ready for testing by the end of 2008, with an expected commercial launch in 2010.
 
Infectious Disease Focus
 
At launch, Beckman expects the initial menu for the DxN to include sexually transmitted disease tests; nosocomial infection tests, including methicillin-resistant Staphylococcus aureus; a compromised immunity test, such as HIV viral load and cytomegalovirus; and urgent microbiology for spinal fluid analysis.
 
“We may have more,” said Garrett. “We won’t have less. If we have more, they’ll probably come from additional infectious disease and human genomics categories, including oncology,” he added.
 
“We believe we have a clear path to MRSA,” said Garrett. “It will be a different approach but a very capable approach.”
 
The molecular diagnostics market for MRSA is currently dominated by two players, Cepheid and Becton Dickinson. Cepheid launched its test in the US earlier this year and has gained rapid market acceptance through a Veterans Administration program for MRSA screening. There is widespread agreement in the molecular diagnostics industry that hospital-acquired infections, in general, represent a major revenue opportunity.
 

“We believe we have a clear path to MRSA. It will be a different approach but a very capable approach.”

Asked during a question-and-answer session whether human papillomavirus testing would be part of the menu of tests, Bill Munroe, Beckman’s director of licensing and business development, said that HPV molecular testing is an “intellectual property challenge.” He added that “it’s on the radar screen” and the firm will continue to explore that possibility.
 
Qiagen, which currently sells the only US Food and Drug Administration-approved molecular test for HPV, is currently embroiled in an HPV patent and antitrust dispute with Third Wave Technologies. The intellectual property barrier to entry in Europe for molecular HPV testing, however, is much lower.
 
Content for the DxN platform will come partially from a collaboration Beckman has with Johns Hopkins University to discover cancer biomarkers. Beckman will have rights to the sequences that Hopkins researchers discover, said Garrett. The sequencing is being done at Beckman’s Agencourt facilities in Massachusetts.
 
In addition, the firm is working with the National University of Ireland, Galway, on a variety of analytes focused on bacterial and fungal pathogens. Beckman also announced this week that it is collaborating with Thomas Jefferson University of Philadelphia and the Laboraf Diagnostica e Ricerca San Raffaele in Milan, Italy, to study genetic signatures for cardiovascular disease and obesity-related hypertension. It plans to eventually deploy content from that alliance on the DxN (see Briefs, this issue).
 
Immunoassay Plans
 
The immunoassay segment is Beckman Coulter’s fastest growing business, company officials said during the webcast. The firm’s Dxi 800 is the platform on which high-value content will be deployed in the future, they said.
 
“This is the system on which the majority of our growth profile over the last few years has been delivered, and it’s the system upon which we expect the growth profile will be dependent in the coming two years,” said Scott Atkin, group vice president of the chemistry, discovery and automation business group.
 
Among the high-value content being developed for the Dxi 800 and highlighted during Atkin’s presentation are tests for preeclampsia, prostate disease, and cardiovascular disease.
 
In addition to those tests, the NexGen technology is expected to be applied to future immunoassay platforms. Garrett said the technology is much faster and possibly more sensitive than Beckman’s current immunoassay technology.
 
“We think there’s a very obvious initial deployment that we can get to relatively quickly, and that’s high-throughput drug screening,” said Garrett. “Because of the sensitivity and simplicity of our new technology, we think that we can do a microplate application that would rapidly replace radioactive isotopes.”
 
He said follow-on deployments would include near-patient testing in the hospital and doctors’ offices. Garrett said the technology would also be implemented “gradually into our mainframe analyzers, immunoassay, and workcells.”

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