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Osmetech Says FDA Clearance of Its Warfarin Test Will Help Expand Menu, Installed Base

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Osmetech said this week that the US Food and Drug Administration has cleared its eSensor Warfarin Sensitivity Test and its second-generation eSensor XT-8 molecular diagnostics platform.
 
The London-based firm, which has offices in Rockland, Mass., and Pasadena, Calif., said that the warfarin test is designed to help physicians identify patients who are at risk for increased sensitivity to the blood-thinning drug. Osmetech submitted its application with the FDA in January (see BAN 1/8/2008).
 
Osmetech is the latest of several firms that have received FDA clearance over the past 10 months for molecular-based warfarin-sensitivity assays. The other firms include Nanosphere, which was the first company to receive clearance; Autogenomics, which also offers an array-based assay; and ParagonDx.
 
CEO James White told BioArray News this week that the clearance of the warfarin test enables Osmetech to play in an established market and creates for the company an easier route for clearing future assays.
 
Last November, Osmetech secured the rights to use a SNP discovered at Wisconsin’s Marshfield Clinic that can be used to determine warfarin dosing (see BAN 11/6/2007). White said that the presence of this marker on Osmetech’s assay, along with the smaller footprint of the company’s system, could distinguish it from other tests on the market.
 
“We had been working on warfarin for a while and the test we have is the standard three-marker test, but the Marshfield marker is exclusive and it differentiates us in the market,” he said.
 
Osmetech entered the array-based molecular diagnostics business when it acquired Motorola-subsidiary Clinical Micro Sensors in July 2005. The firm debuted its first-generation system, the eSensor 4800, later that year and received clearance for the system and a cystic fibrosis carrier detection assay in February 2006 (see BAN 2/14/2006). The company divested its critical care blood gas and electrolyte instrument business for $44.9 million last year to focus solely on diagnostics (see BAN 1/2/2007).
 
According to White, the XT-8 is more user-friendly than its predecessor and was designed specifically for the clinical market. “It’s the same core technology in that there are no fluidics on the system and all the fluidics are in the cartridge,” he said. “It’s very low maintenance and it’s fully random access; you can put any sample on and walk away from that.” White said that the instrument can provide results within half an hour.
 

“What labs are looking for is something that has a small footprint, that is user friendly, and that enables them to have not a PhD running it but a good lab technician.”

At 19 in. x 19 in. x 16 in., the XT-8 is also “extremely small,” White said. “It’s the size of a [computer] monitor, which is very useful in this day and age when people are looking at lab spaces at a premium.” In fact, White said that one of the reasons that array-based molecular diagnostics systems have yet to gain traction in the market is that current systems in the field were designed with the research market in mind as opposed to clinicians, who tend to be more space-conscious.
 
“The fact that we have a low-cost, low-maintenance instrument platform is a huge advantage over something like an Affymetrix platform, which was designed for the research market,” he said.
 
Osmetech’s goal is to continue to add tests to its menu while promoting its XT-8 system using the sales force it established to launch the eSensor 4800, and the distribution channels it has maintained from its blood gas and electrolyte instrument business to clinicians.
 
“The more tests you add to [the] platform will make this really ready for prime time versus having a research mentality and research product and then expecting clinical lab market to buy into that,” White said. “What labs are looking for is something that has a small footprint, that is user friendly, and that enables them to have not a PhD running it but a good lab technician. That is the philosophy that we have taken on board; we are trying a diagnostic approach into a high-growth diagnostic market, versus being a research company trying to operate in a diagnostics market.”
 
Building Momentum
 
Osmetech has placed 20 of its eSensor 4800 systems, and White said that customers are doing “reasonable volume” using its CF detection assay. While the company now must introduce the newly approved second-generation platform, White said that by putting the 4800 immediately into the field, Osmetech was able to create both a reliable cadre of early adopters and a sales and support team that could take on larger projects.
 
“It is very useful to get some units out into the field and use it as a test bed to prove the technology, get the commercial infrastructure up and running, and get revenues flowing,” White said. “The partnerships we have created are very useful, and we have seen that we can compete against rivals. We are happy that we have hit the ground running with a first-gen instrument; and now we can move customers over to the second-gen system.” He declined to discuss pricing for the systems.
 
Currently the company employs 16 sales and support staffers, White said, and in the case of the XT-8 and the warfarin assay, Osmetech is likely to rely on its distribution networks to place the system in the US market before expanding abroad.
 
“Previously, [with the blood gas business] we would have a six-month period in the US, and then look to expand ex-US,” White said. “That’s exactly the model we will be employing here: Get the model bedded down in the US market and then look to expand beyond that. We have relationships with 60 distributors and we have a good network of people to get things moving.”
 
Osmetech is likely to expand that sales and support infrastructure as it rolls out the warfarin assay on the XT-8. The company is also looking at other assays to add to its menu of tests. White said that Osmetech is considering adding tests for markers related to coagulation, such as Factor V/ Factor II prothrombin, or drug metabolism, like cytochrome P450 2C9 and 2D6. An extended warfarin panel and an upper respiratory viral panel are also being planned, White said.
 
“I think the broadening of the [molecular diagnostics] business will come with having more FDA-cleared systems and larger menus of tests on the market,” White said. “I think we are at that point. We are moving from initial adopters to a larger group of customers and the more of these tests you can offer and the more opportunities you can give hospitals to offer better patient care, the more they will take advantage of those opportunities.
 
“The limit has been that there haven’t been that many FDA-cleared systems with an expanded menu; that is where we are getting to now,” he said.