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Abbott s Vysis Subsidiary to Seek FDA Approval for Array-Based Post-Natal IVD

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BOSTON — Vysis, an Abbott Company, will launch a CGH microarray research system this summer, and a similar, FDA-cleared system for the detection of chromosome abnormalities in children with birth defects in 2006, a company official told BioArray News at the Microarrays and Medicine conference, held here last week.

Kathryn Becker, the company's microarray and instrumentation product manager, added that Vysis is about to begin clinical trials for the IVD, indicating that the system could become the first array-CGH-based system to be approved by the US Food and Drug Administration.

Becker said that the new test will be a comprehensive array-based test for the most common chromosome abnormalities observed in children with developmental delay, mental retardation, and physical birth defects, and builds upon the fluorescence in situ hybridization technology pioneered by Vysis, which has been widely used in the field of molecular diagnostics.

According to Becker, the difference between FISH assays and the new array-CGH method is that "FISH allows the cytogeneticist to test for a limited number of chromosome abnormalities through a series of assays, whereas with array-CGH, you can efficiently test for numerous targets." An additional advantage is that array-CGH gives improved resolution compared to FISH.

She said that the new system is similar to Vysis' existing array-CGH GenoSensor system, which sells for $70,000 and includes a scanner, a computer, and a software package.

Among other improvements, the pending diagnostic CGH microarray system will incorporate Tecan's HS4800 automated-hybridization station. The array itself includes 330 bacterial artificial chromosome clones to tests for copy number changes in chromosomal regions that are known to be associated with congenital genetic diseases.

While the new system has more potential for diagnosing genetic disease, Becker said that it will not make the company's original FISH technology obsolete; rather, they are complementary technologies. A CGH microarray will be used for rapid and efficient screening of numerous markers, whereas FISH will be used to confirm array findings.

Clearing the FDA

The company is now preparing to begin clinical trials for the product scheduled to be cleared by the FDA, but Becker would not disclose which institutions would be validating the unnamed pending IVD.

"[The] trial sites have been selected, but not finalized," Becker said. "[W]e have a system [the GenoSensor] that's currently on the market as a research use only system," she said. "A user can buy an entire system and they can run samples for oncology or constitutional genetics as long as it's research based."

She added that there are no FDA-cleared array-CGH diagnostics on the market right now. Roche's CYP450 Amplichip, which uses Affymetrix' Gene Chip Scanner 3000Dx, has been approved for gauging a patient's ability to metabolize certain drugs using SNP analysis, but Becker said that Vysis' new system uses CGH technology for detection of congenital disorders and has few competitors.

One competitor, Spectral Genomics, a Houston, Texas-based company, also offers an array CGH-based product called Spectral Kit, which includes the Spectral Chip 2600 reader and its Constitution Chips. Though a representative from Spectral Genomics could not be reached for comment, the company so far has targeted the research market, with the exception of some customers that are working on clinical diagnostics outside of the US. However, because both products are so new, Becker said it is hard to determine how big the market will be for these competing technologies.

— JP

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