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Nanogen to Seek FDA Clearance for Three Assays on its NC 400 System Next Year

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Riding high on third-quarter revenue gains mostly buoyed by RT-PCR sales, Nanogen last week turned attention back to its array-based NanoChip 400 System by pledging to seek US Food and Drug Administration clearance for the system as well as three companion diagnostic assays in 2007.
 
During a third-quarter earnings call with investors last week, David Ludvigson, the firm’s president and chief operating officer, said that Nanogen expects to submit the NC 400 and three tests — for cystic fibrosis carrier detection, warfarin resistance, and factor V and factor II clotting mutation detection — to the FDA for 510 (k) clearance.
 
Ludvigson said that 510 (k) clearance would represent a “key milestone” in the firm’s agenda for next year.
 
“We expect to have three different submissions through the year of assays together with the system,” Ludvigson said. The first of those, the cystic fibrosis test, will be submitted by the end of the first quarter. “That will be the most visible and most important milestone in 2007,” he added.
 
Nanogen rolled out the NC 400 in the third quarter of 2005 and originally said it planned to submit the system to the FDA this year (see BAN 11/9/2005), although a company spokesperson told BioArray News this week that Nanogen “never gave a firm commitment to an FDA submission timeline.”
 
Since the launch, the company has not disclosed how many of the systems it has placed so far. During last week’s call, Ludvigson acknowledged that the NC 400 has been slow to take off in the market, and voiced hope that FDA clearance could shorten the lead time for adoption.
 
“The sale of this product requires long lead times, but I am pleased with the results the system is receiving,” Ludvigson said. “Most of our sales continue to be into clinical research laboratories and to our non-US distributors and most of the customers are developing their own assays using the open platform capabilities of this system,” he said.
 
“I believe that FDA approval will both expand our potential market and provide a stamp of acceptance for any new customers that are currently sitting on the fence about entering genetic testing themselves,” Ludvigson added.
 
The Three Assays
According to Ludvigson, the cystic fibrosis assay will be the first the company submits for FDA clearance, most likely towards the end of the first quarter of 2007.
 
Nanogen spokeswoman Suzanne Clancy told BioArray News this week that the CF test contains a panel of 23 mutations associated with cystic fibrosis as outlined by the American College of Obstetricians and Gynecologists in a 2004 recommendation.
 
“The ACOG guidelines are the impetus for this assay,” she said. “Their panel of 23 mutations is the panel upon which our test is based. That’s the market for this assay.”
 
When Nanogen’s CF test launches, it will compete directly with Osmetech Molecular Diagnostics, which won approval for its array-based eSensor Cystic Fibrosis Carrier Detection System earlier this year (see BAN 1/24/2006). Another rival will also include Tm Bioscience, whose Tag-It CF carrier detection test was cleared by the FDA in May 2005.
  

“I believe that FDA approval will both expand our potential market and provide a stamp of acceptance for any new customers that are currently sitting on the fence about entering genetic testing themselves.”

However, it is not known how well these tests are actually selling, indicating that the promise of return on investment for the NC 400 is not guaranteed.
 
The second assay Nanogen is preparing for FDA submission is a test for Factor V Leiden, the most common mutation associated with predisposition to excessive blood clotting, and Factor II prothrombin, an enzyme that is associated with hemophilia.  
 
The company is also planning a test for resistance to the drug warfarin, a common anti-coagulant for the prevention of thromboembolism, or the blockage of a blood vessel by a clot.
 
“In general our strategy is to look where molecular testing offers an advantage over current testing,” Clancy said. In regards to warfarin resistance, “there’s a large variation in how well people respond to the drug and there’s a lot of variation related to your genotype” for CYP2C9, the mutation associated with resistance.
 
In addition, Clancy said that the company may have other diagnostics in the pipeline for the NC 400, pointing to an agreement that was expanded in August between Nanogen and Fisher Scientific. Under that agreement, Fisher agreed to provide Nanogen up to $10 million during 2007 and 2008 for the research and development of infectious disease and molecular diagnostic tests.
 
Furthermore, Fisher and Nanogen reaffirmed their decision to explore using biomarkers from Fisher subsidiary Athena Diagnostics, which has an extensive portfolio of markers in the fields of neurology and endocrinology.

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