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Spectral Genomics Seeks FDA Approval For CGH Chips; Cytogeneticists Cautious

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Spectral Genomics sells bacterial artificial chromosome microarrays for use in array-comparative genomic hybridization-based screening for chromosomal abnormalities. Now the Houston, Texas-based company is seeking approval from the US Food and Drug Administration to sell its chips for clinical use, according to a company official.

Ed Chait, Spectral Genomics' CEO, told BioArray News last week that the company has begun discussions with the FDA to clear its Constitution Chip for clinical screening for genetic diseases, and that approval may come as soon as mid-2006.

"We have submitted [preliminary paperwork] and we have continued to work through the process with the FDA," Chait said.

Chait said the Constitution Chip is 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.

Chait also said that it may take some time before the chip is cleared by the FDA for all of the diseases covered on its testing panel, but that some should be approved by this time next year.

"I think we will get some clearance by mid-2006, for certain diseases anyway," he said.

Though the chips are not yet cleared for diagnostic use, Chait said that the company is "marketing [its] chips now with an investigational use label," and has placed them at labs in the US as well as in Italy, France, and the United Kingdom.

Chait said that the company's European clients are using them for both research and diagnostic purposes.

"There are diagnostic laboratories that are using our chips. They are reporting results side-by-side with confirmation from fluorescent in situ hybridization and other conventional techniques, because this is investigational use only," he explained.

Spectral Genomics is one of the more established companies in the developing market for using microarrays to screen for genetic disease. Chait's statement that Spectral Genomics is seeking FDA approval comes only two weeks after an official from Vysis, an Abbott company, told BioArray News that it, too, is about to begin pre-clinical trials for its array-CGH system, which will also be used for detecting post-natal genetic diseases.

Kathryn Becker, Vysis' product manager, told BioArray News this week that Vysis' GenoSensor system, which is being tweaked for in vitro diagnostic applications, is unique in the marketplace because "other companies offer some pieces of the system, but not necessarily the complete package."

The system Vysis is preparing for cytogeneticists may be a more complete package, but Spectral Genomics' Chait said that he believed his company would likely beat Vysis to the market in terms of getting FDA approval.

"Based on having submitted to the FDA we believe we are quite a few steps ahead of Vysis," Chait said.

Cytogenticists 'Very Excited,' but Cautious

Companies like Vysis and Spectral Genomics claim that array-CGH will allow cytogenetics labs to screen for many more chromosomal abnormalities than traditional methods like FISH tests and karyotyping. Several cytogeneticists BioArray News spoke with said that while the technology looks promising, they still have some reservations.

Art Brothman, a professor of pediatrics and genetics at the University of Utah, Salt Lake City, and a scientific board member for Spectral Genomics, told BioArray News that while he was personally "very excited" about the new technology, he recognized that some of his peers were apprehensive about using a new technology in a field that is dominated by FISH tests and karyotyping.

"I think it is something new, and some people may not understand it completely. People are just being very conservative, which is smart, because they can't afford to make a mistake if they are using it clinically," Brothman said.

Brothman said that, just as when FISH was introduced to the field in the late-1980s, it would take time for skeptical cytogeneticists to see the proof that the new technology is reliable enough for them to use.

Another problem cytogenetics labs may face is the cost of array-CGH tests, which some feel may be prohibitive for smaller labs.

Christa Martin, a clinical geneticist from Emory University in Atlanta who will be taking part in Vysis' clinical trials, said that "somebody [who] thinks this is totally out of their reach to get something like this assay into their budget could be worrying about going out of business."

"I think most good academic labs are already starting to think about doing arrays, if they haven't already," Martin added.

Art Beaudet, a pioneer in using array-CGH for screening genetic diseases at the Baylor College of Medicine who also sits on Spectral Genomics' scientific board, said that the tests were cost effective, noting that the amount of data provided by an array-CGH-based test would be worth the cost in equipment from Vysis or Spectral Genomics.

"Its major advantages are that it offers a lot more results for less," he said.

Beaudet said that it would cost $20,000 to $30,000 worth of FISH tests and karyotyping "to get all the information you're going to get out of one array." "He said that the [array-CGH] test currently costs between $1,500 and $1,600 [at Baylor].

Beaudet added that the array-CGH test "is very readily automatable" and will "drive the price down in karyotypes, which are very technician intensive."

"I think this test will replace telomere FISH immediately, and it will replace routine chromosome analysis in the near future," said Beaudet.

"I think this array-based chromosome analysis is a major improvement on existing technologies, and it will be adopted relatively rapidly," he said.

Frank Speleman, a geneticist at Ghent Medical Hospital in Belgium, said that arrays would probably become as widely used as FISH in the years to come.

"DNA arrays are offering interesting new opportunities for pre- and postnatal screening. Certainly arrays or related formats will become very important tools in parallel to cytogenetics and FISH," Speleman said.

— Justin Petrone ([email protected])

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