Expanding its activities in the genetic testing market, TessArae has partnered with an Israeli firm to design a resequencing microarray that can detect specific disease-causing mutations in 11 cancer genes.
Kazerin-based Galil Genetic Analysis will next month launch the Affymetrix-made chip, according to officials from both companies.
GGA CEO Yoram Plotsky told BioArray News this week that the two firms have recently finished developing the assay, called the OncoGenetics RDMGGA 1.0 Re-sequencing Chip. It is designed to enable researchers to simultaneously sequence 11 genes and detect more than 3,300 known disease-causing mutations in one test.
Genes included in the test are BRCA1, BRCA2, APC, MUTYH, MLH1, MSH2, MSH6, TP53, PTEN, P16, and KRAS. The chip is in the final stage of validation and will become available next month in Israel, Plotsky said.
Matthew Lorence, vice president of sales, marketing, and business development at TessArae, said that the partnership with GGA is one of several for the company, which has traditionally served the infectious disease-testing market, but has recently begun offering services to genetic disease-testing firms.
"We are building up a nice portfolio of genetic disease testing assays for very different market segments," Lorence told BioArray News this week. "These assays open the door for other partnerships in those areas."
According to Lorence, Potomac Falls, Va.-based TessArae became aware of GGA's desire to make a cancer gene-resequencing microarray via Affy's Israeli distributor Eisenberg Bros. GGA, a clinical laboratory authorized by the Israeli Ministry of Health, offers genetic tests for the country's medical system and develops new methods for genetic testing.
Since it was founded in 2008, GGA has offered array-based tests, including assays for constitutional disorders and drug metabolism, all on Affy's GeneChip platform. When it came to oncology testing, Plotsky said, the firm was "convinced" that microarray-based testing was "essential" to improve diagnosis and treatment.
"We believe that array-based testing is, mainly, the most efficient way [to perform] DNA and RNA testing," he said.
After looking for a partner to develop the chip, the firm chose TessArae.
"We worked with them to devise a turnkey assay," Lorence said. "We developed a list of mutations for every known gene based on clinical relevance and frequency in the population, and we used their samples to optimize and test the assay."
GGA so far has not sought to develop any other assays with TessArae. However, the two firms are discussing opening the test to other partners.
"They are in Israel and do not have the global reach," Lorence noted, adding that any such deal would probably require TessArae to sell the assay in a kit format.
'A Nice Fit'
Founded in 2005, TessArae specializes in array-based pathogen-detection tools. For instance, its Resequencing Pathogen Microarray platform enables labs to detect and identify viral, bacterial, and fungal pathogens from clinical, environmental, and product samples.
In addition, TessArae sells the RPM-Flu Kit, which is designed to detect and definitively identify respiratory pathogens; the RPM-TEI Kit, for tropical and emerging infections; and the RPM-HFV Kit, which enables whole-genome resequencing of hemorrhagic fever viruses. All of TessArae's chips are manufactured by Affy.
Last year, though, the firm partnered with Gaithersburg, Md.-based GeneDx to provide the genetic disease-testing firm with arrays and software to detect mutations associated with Noonan syndrome, a genetic disorder that causes abnormal development of multiple parts of the body; and periodic fever syndromes, diseases that cause episodic fevers in patients and do not have an infectious cause (BAN 11/10/2009).
From that initial deal, TessArae launched a service business centered on the firm's Gene Cipher assay, which it claims is more efficient and faster than traditional Sanger sequencing and "significantly less" expensive than next-generation sequencing. Lorence declined to discuss pricing details for the assays, however.
Data analysis is central to TessArae's offering. The firm has developed an algorithm to call diploid sequence from the arrays, as opposed to haploid sequence from microbes. The algorithm reads the wild-type sequence from the reference tiles on the array at a greater than 99-percent call rate, and uses an array design strategy to ensure it completely detects targeted mutations, Lorence said at the time of the GeneDx deal.
"It's a nice fit," Lorence said this week of the firm's move into genetic-disease testing. "What we have found to be a compelling benefit is the automated analysis and assay results. We report a list, gene by gene, mutation by mutation, everything we detected, so there is no backend analysis.
"They get the printout, there is the call and the confidence of that call," he added. "Then they can consult other information and see if they agree with that call."
According to Lorence, TessArae is working with a number of undisclosed other clients in the genetic disease-testing space. He said the projects center on recessive diseases, breast cancer, Charcot-Marie-Tooth syndrome, and pre-implantation genetic testing. The firm's clients include an academic client outside the US, a private lab, and an in vitro fertilization clinic, all undisclosed.
Of these assays, the one for recessive diseases is closest to completion. Lorence said he expects that test to launch at the American College of Medical Genetics' annual conference in Vancouver, British Columbia, in March.
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