Galil Genetic Analysis recently began offering its OncoGenetics RDMGGA 1.0 Re-sequencing Chip as a service to its customers in Israel, according to the company's CEO.
Yoram Plotsky told BioArray News that the Affymetrix-manufactured array can be used to sequence 11 genes and detect more than 3,300 known disease-causing mutations in one test.
Kazerin-based GGA designed the chip with TessArae, a Potomac Falls, Va.-based company that develops targeted sequencing applications for human genetic disease and microbial identification. GGA and TessArae have been working on the array for several years (BAN 12/21/2010).
According to Plotsky, GGA has been offering the new chip as a service for the past few months. The company earlier this year finished validating the chip, which resequences 11 genes — BRCA1, BRCA2, APC, MUTYH, MLH1, MSH2, MSH6, TP53, PTEN, P16, and KRAS. The array also contains known mutations, meaning that a mutation picked up in the resequencing of the gene can be confirmed by probes for the specific mutation, allowing an "internal confirmation of the results." Plotsky added that any mutation detected with the chip is confirmed by Sanger sequencing.
GGA is a clinical laboratory authorized by the Israeli Ministry of Health. Since it was founded in 2008, it has offered genetic tests for the country's medical system and continues to develop new methods for genetic testing. In addition to the new OncoGenetics chip, the firm offers assays for constitutional disorders and drug metabolism, all on Affy's GeneChip platform.
Plotsky acknowledged that next-generation sequencing has emerged in recent years as an alternative to array-based targeted gene sequencing approaches. Still, he said that the "level of accuracy" of GGA's OncoGenetics chip is "much better than NGS."
Next-gen sequencing is "not ready for the clinic," he said, "only for research," as it "gives a lot of potential false positives." Plotsky predicted that it would take "between three and five years" before next-gen sequencing would be reliable enough to use for clinical applications.
In the meantime, the firm does plan on offering more array-based tests. Recently it began offering constitutional testing on Affy's CytoScan HD platform, which was launched last summer. "We [run] CytoScan quite a lot," said Plotsky. "It works very well [and has] good software for the analysis." The Israeli Ministry of Health recently began subsidizing chromosomal microarray analysis for high-risk pregnancies (BAN 5/8/2012).
For TessArae, the OncoGenetic chip is the first of its kind. To date, the privately held company has focused on the infectious disease testing market, though in recent years it began designing genetic disease-testing chips with partners such as Gaithersburg, Md.-based GeneDx.
Matthew Lorence, vice president of sales, marketing, and business development at TessArae, told BioArray News that GGA's array is TessArae's first panel to focus on cancer-related genes.
"It was designed specifically for Galil, because it was a service they wanted to provide," said Lorence. "Even though it is cancer, it is really inherited risk. It is not tumor genetics, it is predisposition;" he noted. "With a tumor it is so heterogeneous you don't know what you've got unless you can get a homogeneous sample."
According to Lorence, GGA and TessArae are discussing whether to make the assay available to others. "There is no reason to confine it to Galil if they want to make it more widely available," said Lorence. It is possible that TessArae would distribute the chip, he said.