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Osmetech s eSensor Nears FDA Clearance as Qiagen OKs Bundling Deal, Looks for Other Array Alliances

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Osmetech will bundle DNA and RNA sample-preparation kits made by Qiagen with its array-based eSensor detection system, taking Osmetech one step closer to selling its eSensor system in the United States, the companies said last week.

For Osmetech, the deal shows that its molecular diagnostics platform is closer to winning clearance from the US Food and Drug Administration because Qiagen's kits must formally be made a part of the platform before it can be sold. For Qiagen, it signals that it is looking to make similar deals with other array companies. It has been six years since the company partnered with an array firm for custom sample prep kits.

Bruce Huebner, the head of Osmetech's clinical diagnostics division in Pasadena, Calif., told BioArray News this week that the company signed the Qiagen deal because it anticipated receiving clearance from the FDA to sell its eSensor system. He said Osmetech expects to launch the system in the first quarter of 2006. It was submitted to the FDA in May.

"Our goal right now is to provide an FDA-approved product with these microarrays," Huebner said. "It is hard to tell when you are dealing with the FDA; we do hope it's going to be some time first quarter, that's our plan."

According to Huebner, the first assay the FDA is considering is a test for cystic fibrosis. The company is also working on a cytochrome P450 assay that it will file for clearance if the CF assay is approved.

Huebner said the CYP450 assay is a legacy product that was developed before Osmetech gained eSensor through its acquisition of Motorola's Clinical Micro Sensors unit in July (see BAN 8/10/2005).


"This is one of our main goals for the future: To implement our sample preparation solutions in any technology that is dealing with DNA or RNA analysis."

"We are reinitiating the CYP450 work that was begun a couple years ago at CMS and continuing that project, and it will be the next one on our eSensor platform," he said.

Osmetech acquired CMS through a deal in which Motorola invested £3.7 million ($4.6 million) in Osmetech and retained the option to buy 78 million shares in the company at an issue price of 1.75p before July 2010. After the August transaction, Motorola owned 16 percent of Osmetech, Osmetech CEO James White told BioArray News at the time.

The eSensor system includes the eSensor 4800 reader, which uses electrochemical detection to register results from a customizable single-use eSensor biochip disposable cartridge.

Qiagen Kit

The Qiagen kit that Osmetech will be selling includes DNA sample-preparation and RNA-preparation samples that are tailored to work with the requirements of the eSensor system, according to Solveigh Mähler, Qiagen's head of investor relations. Osmetech has been using the kits in-house and now hopes to bundle them as part of the eSensor offering.

"The Osmetech technology needs a specific optimized solution for the sample preparation. So these will be customized kits that we are providing to Osmetech that they can sell together with their bioarrays," she told BioArray News this week.

Mähler said that the deal illustrates Qiagen's desire to partner with other array companies to produce similar kits.

"This is one of our main goals for the future: To implement our sample-preparation solutions in any technology that is dealing with DNA or RNA analysis," she said. "The more cooperation we can find, the easier it will be to create a standard in this area."

According to Mähler, Osmetech is the second firm with array technology for whom Qiagen has chosen to manufacture kits in the past six years. Qiagen has had a similar agreement with Affymetrix since November 1999, according to Affy's website.

"This is the only [other] connection to these kind of companies that we have," Mähler said of the relationship with Affy.

Future Possibilities

Though Osmetech and Qiagen don't plan to pen additional deals, Osmetech's Huebner did not rule out an extension of the partnership created this week.

For example, Huebner said that Osmetech's clinical diagnostics division also aims to introduce a thermocycler it picked up with the acquisition of UK-based Molecular Sensing, along with a thermocycler tube "that will work on any light cycler on the market."

"There are more products in our bag to sell and we will have a common US sales force that will sell all the items," said Huebner. Hypothetically, Huebner said Osmetech could add some Qiagen tools to strengthen its offering.

"They do have a front-end sample processing-system to get genomic DNA available for the [eSensor assays]," he said. "Currently, we can use our assay after the customer has done their own extraction with whatever system they want, but conceptually someday we may decide to provide sample extraction right with the kit to be one-stop shop. That would be a possibility with Qiagen," Huebner said.

He also said he imagined that Qiagen could be interested in Osmetech's thermocylcer tube, but that these were "just possibilities."

In addition, Huebner said Osmetech will most likely be announcing in the near future similar agreements with companies that make components that are used in the eSensor system.

"There are some other components that we need to have in our particular kit [and] … we have sort of … small OEM relationships that will be occurring and will be announced," Huebner said. He said that an announcement regarding a partnership with eSensor's undisclosed probe provider — the company does not make its own — would be forthcoming.

— Justin Petrone ([email protected])

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