Genomica, a Spanish molecular diagnostics firm, will debut later this year array-based tests for sepsis and enteric diseases, according to a company official. The diagnostics will join a menu of assays Madrid-based Genomica has introduced since it entered into a partnership with German array firm Scienion two years ago.
Juan Bataller, director of exports and distribution for Genomica, told BioArray News that the firm will launch the tests before the end of the second quarter. The assays will run on Genomica's clinical array technology, or CLART, platform, which relies on arrays manufactured by Berlin-based Scienion.
Founded in 1990, Genomica began to migrate its tests to a microarray format in 2003. For a number of years, it provided its tests in an array tube format manufactured by Jena, Germany-based Clondiag Chip Technology, now part of Alere Technologies. Array tubes consist of micro-probe arrays integrated into a micro-reaction vial.
Two years ago, though, Genomica began to work with Scienion, which manufactures arrays in a plastic, 96-well microplate format. The platform, commercialized by Scienion three months ago as the SciPlex Plate, allows users to break off strips of wells depending on how many assays they need to run. Bataller said that currently Genomica can run eight assays at a time on its CLART platform, but will be able to run one assay at a time on its system by the end of Q2.
The CLART platform includes the firm's Clinical Array Reader and the Clinical Array Processor, which are manufactured by undisclosed third parties. The CLART assay includes DNA extraction, DNA amplification and target labeling, and specific hybridization and visualization of the results, according to Genomica's website.
The Clinical Array Reader then analyzes the precipitation staining pattern on the array and the results are shown on the system's touch screen and can be printed or exported.
Since it began working with Scienion, Genomica has moved a number of its assays to the new array format. For example, the company now offers array-based assays for human papillomavirus, which allows users to detect infections and co-infections of up to 35 HPV genotypes and is CE-IVD marked. Other assays cover viral respiratory diseases, such as influenza.
Genomica also sells RT-PCR-based assays for a number of diseases, but Bataller estimated that between 60 percent and 70 percent of the privately held company's annual income is generated by CLART sales. He added that nearly 90 percent of Genomica's products are manufactured by Scienion.
Bataller said that Genomica chose to partner with Scienion because of the "quality and consistent spotting" of its chips. In addition, the fact that Scienion is able to spot on plastic enables Genomica to keep the cost of its tests down. The firm's main clients are routine clinical labs in hospitals. Bataller said he expects the two new panels for sepsis and enteric diseases to be adopted by this market.
Genomica currently sells its own products in Spain and has distributors in more than 30 countries. Most of its assays are CE-IVD marked and Bataller said that Genomica will pursue similar marking for the sepsis and enteric disease panels. He added that the firm is also registering its assays for clinical use in other markets, such as the Russian Federation, Brazil, and Canada. The company plans to eventually seek US Food and Drug Administration clearance for its tests, but Bataller declined to provide a timeline for any FDA submissions.
In the sepsis testing market, Genomica's most similar competitor is probably Mobidiag, a Helsinki, Finland-based molecular diagnostics firm that also sells an array-based sepsis test, called Prove-it Sepsis (BAN 12/15/2009). Mobidiag's test is available in an array tube format, as well as an array strip format.
Bataller said it is "difficult to find a direct competitor, because it is a different technology and a different approach."
The IVD Value Chain
Scienion CEO Holger Eickhoff told BioArray News this week that the firm is interested in seeing more diagnostic partners move to its arrays. He said that since the SciPlex Plate was officially launched in November, Scienion has started "several projects to move content to these plates" and is currently involved in pilot studies with these collaborators. He estimated that Scienion will "convert another two or three" diagnostic firms to its array platform by the end of this year.
According to Eickhoff, IVD partners are "important" for the firm's business. He noted that the fact that the arrays are spotted on plastic is a "big cost advantage" for firms like Genomica. "If you want to go into the diagnostics market, a high-quality glass slide is too expensive to be used as a diagnostic tool," he said.
Eickhoff similarly told BioArray News last year that the firm was looking to attract more IVD firms to its platform. "I think that diagnostics is the key customer segment that we are dealing with today," he said in July 2010. "Diagnostic companies are our key market" (BAN 7/27/2010).
Eickhoff noted that "one thing that is important" for attracting new IVD partners is Scienion's certification from the International Organization for Standardization for its microarray offerings and dispensing systems, which it received two years ago (BAN 2/24/2009).
Scienion was founded in 2000 and has specialized in arraying instruments and services. It has launched six distinct sciFlexarrayer instruments to date: the entry-level model DW, which can produce four arrays in one run; the S3 for R&D applications; the S5 and S11 for medium-throughput array manufacturing; the S100, which can produce more than 1,000 arrays per run for high-throughput manufacturing; and the compact SX system, which includes components from all of Scienion's arrayers in one enclosure.
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