The US Food and Drug Administration's 510(k) clearance in January of a cystic fibrosis carrier-detection assay on Osmetech's eSensor 4800 DNA Detection platform came six months after the company acquired the technology from Motorola.
The clearance, which Osmetech plans to follow in the second quarter with a launch, also places the company ahead of other array companies whose own assays are currently queuing at the FDA, including Spectral Genomics and PathWork Informatics (see BAN 1/24/2006).
Now that the company can sell its system directly to clinicians and is prepping its second assay for regulatory clearance, the question is, "What's next?"
According to Bruce Huebner, president of Osmetech Molecular Diagnostics, the company is planning a targeted market release in the US this spring for the eSensor system and accompanying CF assay, and is now looking to co-develop diagnostics with other parties.
"We are on track to start selling our cystic fibrosis carrier detection system next quarter and everything is on target from our standpoint," Huebner, former president and chief operating officer at Nanogen, told BioArray News this week.
"Microarrays have not fared well in the marketplace. You've got the Affy extreme, which is [with] very research-oriented, expensive arrays. And then there've been a number of [clinical] trials involving microarrays that haven't worked that well. We are going to take it step by step and make sure we have a product that works effectively in the lab and that's what our goal is."
To accommodate the launch, Osmetech concluded a bundling deal with Qiagen in November to sell reagent kits with the eSensor system, and Huebner said that the company is assembling its new sales force (see BAN 11/30/2005).
"We will have two [sales representatives] on board next month, trained and ready to move forward, and we plan to add another rep sometime this year," he said. "Tech support is in place here in Pasadena, Calif., [and] we'll continue to grow as we have a controlled release of this product."
Although Osmetech Ltd., OMD's parent company, is based in the UK, the eSensor will not be available in Europe this year. However, Huebner said that OMD will be looking into distribution opportunities through its parent company, which sells critical care blood gas products.
"The critical care blood gas business has already got a distribution channel," Huebner said. He added that Osmetech Ltd. has about 40 distributors worldwide in place, so in "certain circumstances the accounts themselves will be the same with respect to installing a molecular platform." Osmetech Ltd.'s US office is based in Roswell, Ga.
Though OMD is looking to take advantage of Osmetech Ltd.'s distribution channels, Huebner said the company is looking outside of its R&D department when it comes to content for future assays.
"Obviously, menu is an important part of getting more assays on your platform, and there's no doubt that we have project development plans going on here, that we'll continue to add to," Huebner said. "But we do believe that, by getting an FDA-approved product and validating that the technology really works, it can be a viable platform to partner with other people that may want to put some of their IP on a platform for specific applications," Huebner said.
"So we are exploring partnerships with those types of situations with companies that are potentially looking for ways to get their product on a platform," he added.
Discussions are currently underway with interested parties, Huebner said, but he said negotiations were too preliminary to reveal anything publicly. However, he said the decision to open the eSensor platform to assays developed outside of Osmetech underscored an evolution in the company's strategy.
"Since Osmetech acquired Clinical Micro Sensors, the [strategy] has been evolving as we look into ways we can expand and then leverage our technology," Huebner said. Huebner declined to suggest what kinds of assays Osmetech could be interested in, but said that his company "would like to get as many products on the system as possible" and that it could "put those new products through [its sales and distribution] pipeline."
Sales & Service Force
For Osmetech's distributors and new sales and support teams, their road will be the one less traveled, or actually not traveled at all. In a marketplace where the model for selling array-based diagnostics to clinicians has been forged by Roche Molecular Diagnostics and Affymetrix, the path for smaller firms is not immediately clear.
"Microarrays have not fared well in the marketplace," he said. "You've got the Affy extreme, which is [based on] very research-oriented, expensive arrays. And then there've been a number of [clinical] trials involving microarrays that haven't worked that well," Huebner said. "We are going to take it step by step and make sure we have a product that works effectively in the lab and that's what our goal is."
Huebner also said that when it comes to competing against larger firms like Roche -- especially once Osmetech brings its CYP450 assay through the FDA sometime in 2007 -- it will be relying on the strength of its technology, and a less expensive product, to give it an edge in the marketplace.
"Microarrays have application in the clinical lab," Huebner said. "In our case we are doing a much more simplified version of what [Roche] is doing on an Affy chip," he said about Roche's CYP450 AmpliChip. "We believe strongly that we've got cost-competitive advantages over that chip and that we are going to be able to make it less expensive and provide it as a cost-effective alternative [to] a specific Affy chip." Roche does not currently market an array-based CF IVD.
Osmetech "can provide [its impending CYP450 test] for a lot less than what Roche is selling the AmpliChip for in the market," Huebner said. "Our instrument is also a lot less complicated compared to the Roche system. Our whole goal is to decentralize the testing out of the big reference labs and make it more readily available to more laboratories in the marketplace," he said. Huebner declined to offer pricing information on the CF assay and eSensor system.
Roche CEO Heiner Dreismann declined to comment on Roche's pricing strategy for the AmpliChip for this article, although he told BioArray News earlier this month that it was inevitable that its current price could decline to around $100 in the future (see BAN 3/7/2006).
BioArray News' sister publication Pharmacogenomics Reporter reported last December that LabCorp charges $1,360 for a typical AmpliChip test per patient sample.
— Justin Petrone ([email protected])