This article has been updated to include comments from CytoGenX.
CytoGenX, a Stony Brook, NY-based medical genetic testing services company, recently introduced chromosomal microarray analysis for a number of different indications.
The new offering, called the Assure platform, relies on a high-density chip to identify disease-causing genetic alterations in prenatal and pediatric diseases as well as cancer and infertility.
Teresa Dunn, CytoGenX's laboratory director, told BioArray News that the privately held medical genetics lab has been able to offer CMA since achieving a license from the New York State Department of Health last month.
The company has previously offered CMA via reference laboratories in other states, Dunn said. "We gained a lot of insight into the technology by working with reference labs," she noted.
According to Dunn, the company now offers CMA on Affymetrix's CytoScan platform. The chip contains 2.67 million markers for copy number analysis, including 750,000 SNPs and 1.9 million non-polymorphic probes.
"This is really the best chip available with clinically relevant content," said Dunn. She noted that Affymetrix submitted CytoScan to the US Food and Drug Administration for clearance earliest this year. The firm has not commented on when it might achieve clearance for the array-based offering.
While CytoGenX has a number of competitors, including a number of firms that either are, or are part of, publicly traded companies — such as Burlington, NC-based Laboratory Corporation of America, PerkinElmer's Signature Genomic Laboratories in Spokane, Wash., or Irvine, Calif.-based CombiMatrix — the company is using its Long Island location to its advantage, Dunn said.
She noted that the firm offers a courier service for customers in the New York metropolitan area, which covers parts of New York State, New Jersey, eastern Pennsylvania, and Connecticut, and has an estimated population of around 24 million people.
This car-based delivery "assists us in offering an expedited service to clients that is not hindered by transport issues," Dunn said.
Other regional competitors include large university labs or hospitals that offer CMA, such as Children's Hospital Boston or Columbia University Medical Center.
Dunn distinguished CytoGenX from such labs by noting that it is privately held, and focused exclusively on genetic testing, as opposed to larger university labs, which may offer a multitude of tests.
"I think there are very few private labs offering this kind of testing," said Dunn, noting that the company also offers genetic counseling. "We are not in a university setting or a large lab, and we really specialize in what we do, which is why we strive for a quick turnaround time and support."
While Dunn did not disclose the price of the company's CMA offering, she said it is competitive with other CMA services. She added that the firm's turnaround time is within a week of receipt.
One area were CytoGenX might be out-muscled by competitors is in sales and marketing. Larger companies like LabCorp and PerkinElmer have extensive sales and marketing channels, while CombiMatrix has in recent years sought to build out its sales efforts, with a resulting spike in testing volumes.
Dunn said that the company is trying to expand its sales force at the moment, and now reaches customers via a variety of routes — sales personnel, web advertisements, and professional society appearances.
While the majority of the company's customers are on the East Coast, she noted that the firm has clients elsewhere in the US and abroad.
In a statement last week, CytoGenX said that new guidelines from professional organizations encouraged the company to offer the new array-based service.
Specifically, it referred to recent American College of Obstetrics and Gynecologists guidelines that recommend the use of CMA to all patients undergoing an amniocentesis or chorionic villus sampling and that the tests should not be restricted to women age 35 and older.
CytoGenX also noted that the American College of Medical Genetics has recommended the use of CMA as a first-tier diagnostic test for both postnatal and prenatal samples, and as a complementary approach in diagnosing neoplastic disorders.
While the ACMG recommendations have been out for years, Dunn said that she hopes the ACOG guidelines could spur demand for CytoGenX's new Assure service, noting that the recommendations "shed more light on noninvasive prenatal testing" and the idea that CMA is "able to diagnose what some of the sequencing-based tests are missing."
While next-generation sequencing-based non-invasive prenatal testing offered by companies like Illumina-owned Verinata Health, Natera, and Ariosa Diagnostics continue to gain acceptance, they are viewed by some as not being as comprehensive as array-based chromosomal microarray analysis.
Researchers at Baylor College of Medicine have been developing a noninvasive version of its chromosomal microarray analysis offering, but they estimate that the launch of such a test, even for research, could still be years away.