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GE Seeking FDA, EU Approval for CodeLink P450; Protein Array in R&D


VANCOUVER, BC -- GE Healthcare plans to submit its CodeLink P450 SNP bioarray platform for market clearance for use in in vitro diagnostics in the United States and Europe, a GE official said here last week at the World Microarray Congress.

The official also said the company is in the process of developing its first ever protein array.

"We are going into the diagnostics market," Brad Cooney, a field application specialist for CodeLink, told congress participants. "We are just going through the FDA trials, and we hope by the end of the year 2005 to have our CE [Mark] in Europe."

The announcement comes on the heels of an FDA guidance document released March 10 that lays out a roadmap for companies seeking 510(k) clearance of a drug-metabolizing diagnostic (see BAN 3/16/2005).

The document is a direct result of the process by which Roche's CYP450 AmpliChip and Affymetrix' 3000Dx platform received FDA clearance in December 2004. Roche's chip analyzes a pair of genes that could help physicians determine how patients metabolize drugs that are dependent on the CYP2D6 and CYP2C19 genes.

The CodeLink P450 bioarray, by comparison, is actually four delineated samples of 110 SNPs apiece on one slide that can be used to detect drug metabolism for drugs affected by the 2D6, 2C9, 2C19, 1A1, 1A2, 2E1, 3A4, 3A5, and 1B1 genes.

"A set of enzymes can tell you whether or not you'll be responsive to certain drugs," Cooney explained. "Some people can't break the drugs down, so their doctors prescribe more drugs, which quickly get to the toxic level."

Cooney said that it would currently take users "a couple days" to do a full P450 analysis but said the company was looking to move analysis to a lab-automated format that would shave off some time between running a sample and having a result ready for a prescribing physician.

GE Healthcare is also following the path tread by Roche by seeking European approval first while simultaneously navigating its way through the US Food and Drug Administration approval process.

"The European approval process is much easier," said Cooney. "As for the FDA -- we are just starting into that. We are at the very initial phases of gaining FDA approval."

The recent approval of the AmpliChip has emboldened Roche and Affy rivals to seek FDA and European approval for their own drug-metabolizing chips. Greg Hines, CEO of Tm Bioscience, a Toronto-based Roche competitor, in January said his company would be seeking approval for its CYP450 diagnostic in the first quarter of 2005. Hines spoke with Pharmacogenomics Reporter, a BioArray News sister publication.

Similarly, Eli Lilly and ParAllele have been developing their own drug-metabolizing genotyping test, which ParAllele will submit to the FDA within the next 12 months.

Protein Array

Cooney also told participants that GE Healthcare, which acquired CodeLink when it bought Amersham Biosciences in 2004, was in the process of developing its first-ever protein array.

"We are developing a protein array platform offering," Cooney said, adding that he could not comment about how that platform would differ from protein arrays being developed or offered by other companies, such as Invitrogen. In fact, he said the project was "so secretive" that he did not himself know the specifics of what will be CodeLink's protein array.

"That's in the works, I know that," said Cooney.

If GE Healthcare delivers on its protein array promise, it will join a host of other array companies angling for a chunk of the emerging market, which analysts predict will grow to between $336 million and $450 million over the next three years (see BAN 3/16/2005).

For example, last week Uppsala, Sweden-based Biacore acquired HTS Biosystems' FlexChip Kinetic Analysis System to get a boost in the protein-array market, following other competitors in the microarray space like CombiMatrix and Invitrogen, which have announced plans to carve out a piece of the market.

Invitrogen followed up on its plans by releasing its first high density protein array in November. (see BAN 11/23/2004).

GE Healthcare did not respond to additional questions about its protein array, or disclose details of its development timeline.

Last April, GE launched its whole human genome chip, which was followed in August by the rat whole-genome array. The company released its mouse whole genome arrays last October (see BAN 10/20/2004).

-- JP


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