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LabCorp Offers CGH Using Spectral Genomics Microarrays, May Replace Cytogenetic Methods

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Laboratory Corporation of America is offering a new comparative genomic hybridization service using arrays based on Spectral Genomics' CGH platform, Paul Billings, LabCorp's senior geneticist and vice president for biotechnology and healthcare strategy, told Pharmacogenomics Reporter.

The service, launched this week, will be used to diagnose more than 80 genetic mutations associated with mental retardation and learning disabilities, the company said last week.

Asked how much CGH testing LabCorp anticipates conducting yearly, Billings said, "I don't think we really know — we feel that the target market is children in whom cytogenetic testing has been a key part of the workup of developmental delay," including autism and various learning disabilities.

Billings said that the new service will be available to clinicians seeking to diagnose chromosomal abnormalities in patients, particularly children that have yet to receive a positive diagnosis. "The average customer now has the opportunity to order CGH as a screening tool in the work-up of appropriate patients," he said. "We feel that the data would support its utilization in the work-up of kids with syndromes of uncertain diagnosis at this point, but I think indications are in evolution."

Another possible use for the service will be to re-evaluate patients that were diagnosed decades ago with less-developed technology to see if a new diagnosis can result in better treatment, Billings said.

LabCorp will continue to use fluorescent in situ hybridization testing to confirm any positive diagnoses made with the array-CGH platform until the technology is more developed, at which point FISH may be eliminated altogether, said Billings.

Billings said that the company selected the Constitution Chip, which is designed to test for DNA structural defects in a large number of chromosomal regions known to be associated with specific syndromes, primarily because of its immediate availability.

The LabCorp launch comes at a time when many companies are entering the nascent CGH market, according to Pharmacogenomics Reporter's sister publication, BioArray News. A large number of array-CGH products have been released over the last year, so the selection may give Spectral Genomics a leg up in the developing marketplace.

In an interview with BioArray News last May (see BAN 5/25/2005), Spectral Genomics' former CEO Ed Chait described its Constitution Chip as a "purely genetic chip" that "analyzes 42 genetic diseases and 41 sub-telomere syndromes," and would be useful for post-natal screening for children who may suffer from genetic diseases but lack positive diagnosis.

In addition to offerings from Agilent and Vysis offerings, LabCorp had to choose from high-density array-CGH chips from NimbleGen, which were launched in March, as well as Spokane, Wash.-based Signature Genomics, which launched its CGH Signature Chip last year.

In light of alternative offerings from Agilent, Vysis and NimbleGen, LabCorp's Billings said that his company could eventually add or switch platforms in the future.

"[When we selected Spectral Genomics], it appeared that they could provide chips with a reasonable quality, that they knew their chips could perform on their readers — and that was needed at this point in time. It very well may be that other providers later on make more sense," Billings said.

— Justin Petrone ([email protected]) and Chris Womack ([email protected])

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