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With Qiagen Deal, eSensor Nears FDA Clearance

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In early December, Osmetech said it would 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.

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.

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

According to Bruce Huebner, head of Osmetech’s clinical diagnostics division in Pasadena, Calif., the company signed the Qiagen deal because it anticipated receiving clearance from the FDA to sell its eSensor system. He says 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 says. “It is hard to tell when you are dealing with the FDA; we do hope it’s going to be sometime 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.

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.

— Justin Petrone


The Canadian government will contribute up to CA$6.45 million over the next three years to support a genomics research project on cod aquaculture. The total value of this four-year project is CA$18.2 million.

ExonHit Therapeutics has validated biomarkers for blood-based detection of bovine spongiform encephalopathy in living animals through a partnership with Roche Applied Science. The company will exclusively retain all IP related to the discovery and is looking to license it to a partner that can finish developing a BSE test.

Because traditional flu-vaccine development and production are too slow to accommodate rapidly evolving flu strains, Novavax and CombiMatrix are developing a technique to monitor vaccine production by tracking the genetic fidelity of the genes encoding the vaccine.

EcoArray has launched the first version of its fathead minnow chip, a 2,000-gene array. The chip was developed on an Agilent platform through a partnership with the US EPA.

Affymetrix has made available its new tiling arrays to early-access customers and plans to commercially launch the products — which survey the coding and non-coding regions
of the genome — during the first quarter of 2006.

PATENT WATCH

US Patent No. 6,972,326. Labeling of immobilized proteins using dipyrrometheneboron difluoride dyes. Inventors: Richard Haugland, Karen Martin, Wayne Patton. Assignee: Molecular Probes. Issued: December 6, 2005.

The patent covers methods for labeling or detecting immobilized polyamino acids, including peptides, polypeptides and proteins, on membranes and other solid supports, using fluorescent dipyrrometheneboron difluoride dyes. Such immobilized polyamino acids are labeled or detected on blots or on arrays of polyamino acids, or are attached to immobilized aptamers.


US Patent No. 6,969,489. Microarray for high-throughout screening. Inventor: Alex Freeman. Assignee: Cytoplex Biosciences. Issued: November 29, 2005.

The patent covers a microfluidic system comprising two substrates where array-based fluid is stored in through-holes that extend through one of the substrates. Combined capillary and hydrophyllic forces are used to retain the fluid and also transfer it to other substrates of similar type. According to the patent, vacuum and pressure forces can also be used to introduce the fluid and remove the fluid from the known through-holes and transfer the remaining fluid to other substrates.


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