Boston — Following last year's launch of its research-only GenoSensor system for array comparative genomic hybridization studies, Abbott Molecular hopes to win European and US regulatory approvals to sell an in vitro diagnostic version of the system — called GeneTrait Microarray System Dx — in the first half of 2007, according to a company official.
The timeline is noteworthy because when Abbott's Vysis subsidiary first discussed the development of the clinical-use system in May 2005, it said it would be on the market for clinical use this year. The company, which was consolidated as part of Abbott Molecular last year, has until now declined to reaffirm or adjust those predictions (see BAN 5/11/2005, BAN 1/3/2006).
With the array CGH market still nascent, the future launch could help Abbott further distinguish itself as one of the few companies that offers an array CGH test cleared by the US Food and Drug Administration.
Don Braakman, a spokesperson for Abbott Molecular, this week said the company "expects" the system to obtain FDA clearance "most likely in the first half next year." Braakman added that Abbott Molecular will also pursue a CE Mark for GeneTrait before it is launched in the US. He declined to be more specific..
Ekaterina Pestova, a senior scientist at Abbott Molecular, said the GeneTrait system is designed to detect common, post-natal constitutional abnormalities that might lead to developmental delay, mental retardation, and physical birth defects.
"We have plans for future arrays in other areas such as oncology but we have no specific arrays or applications identified at this time."
Pestova discussed the GeneTrait system during a presentation at Cambridge Healthtech Institute's GOT Summit, held here last week.
The automated assay that runs on the system uses an array that includes 333 bacterial artificial chromosomes, including 82 subtelomere clones and 28 microdeletion and microduplication clones, Pestova said. The system can detect chromosomal copy number changes of multiple genomic regions in one assay.
The system automates assay formatting, data analysis, and the ability to detect copy number changes. During an experiment, the user can use PCR to verify clone ID, and fluorescent in situ hybridization to verify specificity and cytogenetic location, Pestova added. She also said that the system will include GeneTrait labeling and hybridization kits.
Hybridization is provided by a Tecan HS4800 system, according to Braakman. He added that, unlike the research-only GenoSensor system, the GeneTrait system uses a PC rather than a Macintosh computer.
During her presentation, Pestova also said Abbott could expand GeneTrait's applications to include oncology work. "We hope that after this project is over and our system is released then we will begin work on tumors," she said.
Braakman this week agreed that Abbott Molecular has "plans for future arrays in other areas such as oncology," but said it has "no specific arrays or applications identified at this time." Braakman also declined to discuss any constitutional chip-related clinical trials that the system may be involved in at the moment. However, last year the company confirmed that it plans to run such trials.
Segmental Aneusomy Software
A key feature of the GeneTrait system is its set of informatics tools, which the firm calls its GeneTrait Segmental Aneusomy Software.
In Boston last week, Pestova said the software offers image analysis, quality assessments, and data analysis, as well as quality control parameters that include an algorithm called "segmental aneusomy" that assesses image quality. According to Braakman, the software also assesses overall hybridization quality based partially on several image criteria, and provides individual clone p values and chromosomal segment p values.
Pestova explained that the software uses a CCD camera for image acquisition, and that "unlike laser scanners, the camera captures three different images and saves them together. Then the software creates a composite image."
Braakman noted that Abbott has obtained IP rights related to GeneTrait, including US Patent No. 6,905,823, "Cellular arrays and methods of detecting and using genetic disorder markers," granted in June 2005 (see BAN 6/15/2005).
As Abbott moves closer to submitting GeneTrait for FDA approval, it is distinguishing itself as one of a small number of companies playing in the array CGH arena that sells a product rather than a service. And although the market for array CGH has remained relatively static, a few key events over the past month have shifted the landscape.
Most notably, PerkinElmer announced this week that it has acquired Spectral Genomics, a privately held Houston, Tex.-based firm that, like Abbott, has been pursuing FDA approval for a chip that uses array CGH to detect constitutional abnormalities (see Briefs).
Spectral's former CEO Ed Chait told BioArray News in 2005 that the company could gain regulatory approval for its system by the second quarter of this year, although the firm has yet to announce any regulatory approval for its tools, and has since declined to comment on the approval process (see BAN 5/25/2005, BAN 1/3/2006).
Another player is CombiMatrix Molecular Diagnostics, which inked a deal with Array Genomics in March to manufacture array CGH tests for sale in Europe. Last week, CMDX began shipping its first chip, which detects genomic copy number variations associated with constitutional chromosome imbalances and imbalances associated with over 40 defined genetic diseases and syndromes. CMDX also intends to sell the arrays domestically for research use only until it can gain FDA clearance (see BAN 4/25/2006).
A third player in the array CGH space, albeit with a less defined role, is UK-based Oxford Gene Technology, which has been providing Oxford Genetics Knowledge Park, a government-funded think tank, with arrays for studying colorectal cancer and learning disabilities. Oxford has indicated that it would like to begin using CGH arrays clinically at cytogenetics labs in the UK (seeBAN 2/14/2006).
On the other side of the coin, Signature Genomic Laboratories and Baylor College of Medicine's Medical Genetics Laboratories both offer exclusively as a service array CGH analysis for detecting constitutional abnormalities.
— Justin Petrone ([email protected])