Laboratory Corporation of America, the diagnostic testing giant, is launching a new array comparative genomic hybridization service based on Spectral Genomics' CGH platform, BioArray News has learned.
The company announced last week that it will begin offering the CGH service to diagnose more than 80 genetic mutations associated with mental retardation and learning disabilities, but did not name the platform provider.
According to Paul Billings, LabCorp's vice president and national director of genetics and genomics, the testing service will be based on Spectral Genomics' Constitution Chip. Billings said the service launched this week.
However, Billings also said that the CGH platform could change or other platforms could be added in the future.
The LabCorp launch comes at a time when many companies are entering the nascent CGH market. 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.
Although Spectral Genomics did not return calls for comment by press time, in an interview with BioArray News last May (see BAN 5/25/2005), the company's former CEO Ed Chait described the 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.
"It appeared that [Spectral Genomics] could provide chips with a reasonable quality and 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."
Chait said that Spectral's strategy at the time was to market its chips with an investigational use label, and to place them at labs in the US as well as in Italy, France, and the United Kingdom. The agreement with LabCorp indicates that this strategy has paid off.
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.
"We looked at what was available [in] the marketplace now and what was likely to come on in the next six to 12 months, and we thought that we wanted to get launched right away. But at this point Spectral's quality was what we needed. This is a field where there are many entrants," Billings explained in an interview with BioArray News this week.
"Many entrants" is correct. While Spectral Genomics has had a head start in the CGH space -- its chips became available in 2004 -- it was joined this year by Agilent Technologies, NimbleGen, and Vysis.
Just last month, Agilent launched its Mouse Genome CGH Microarray, a 43,000-probe array that the company claims covers the most commonly studied chromosomal regions and cancer-related genes. Agilent said that it would be adding more organism-specific CGH arrays in the future (see BAN 8/24/2005).
The release builds on the launch of the company's Human Genome CGH Microarray, which was launched last January (see BAN 1/26/2005).
Vysis, an Abbot company, last summer launched a CGH microarray research system and said in May that it was initiating clinical trials in a push to get the system approved by the US Food and Drug Administration in 2006 (see BAN 5/11/2005).
The Vysis system is a more direct competitor to Spectral Genomics.
Kathryn Becker, the company's microarray and instrumentation product manager, told BioArray News at the time that the new test would be a comprehensive array-based test for the most common chromosome abnormalities observed in children with developmental delay, mental retardation, and physical birth defects.
In addition to Agilent's 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 all these offerings, 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.
Billings, himself a cytogeneticist, 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 reevaluate patients that were diagnosed decades ago with less-developed technology to see if a new diagnosis can result in better treatment, Billings said.
"I am a geneticist by background and I feel very strongly that there are a large number of cases where either initial screening needs to be done for chromosomal anomalies or reevaluation needs to be done," he said.
Pricing for the service has yet to be released.
Billings said that 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.
"We are currently confirming all positives with FISH testing and we do that as a free service. If the quality of the chips [improves] over time and [the] density of markers and all other issues [improve], eventually we will go to a time when we don't need to follow up with FISH," Billings said.
— Justin Petrone ([email protected])