NEW YORK (GenomeWeb News) - Exiqon President and CEO Lars Kongsbak this week said that the company would not launch its first microRNA-based diagnostic, a test to predict colon cancer recurrence, before the end of the year as previously announced. Instead, the test is slated for introduction sometime early in 2009.
He said the company has yet to submit the test for regulatory approval, but it expects to do so before the end of the month. Exiqon intends to seek that approval from the New York State Department of Health, even though commercialization of the test will be handled by its California-based subsidiary Exiqon Diagostics, formerly Oncotech.
Kongsbak said clearance by New York’s health department is “considered the most complicated approval to obtain because [that agency] has the most sophisticated and advanced system” to assess products. Therefore, if the company wins approval there, “it will be less complicated to get approval from other states in the US,” he added.
Exiqon isn’t the only miRNA diagnostic company taking this tack. This summer, Rosetta Genomics obtained approval from the NY agency for its first miRNA test, which differentiates squamous from non-squamous non-small cell lung cancer. The company launched that test this week.
But ultimately, state regulators may not be the issue for miRNA diagnostics developers. Last year, the US Food and Drug Administration indicated that it may begin regulating so-called home-brew diagnostics available through clinical laboratories. However, it is not yet clear how this oversight will impact miRNA tests.
Kongsbak told GenomeWeb Daily News sister publication RNAi News this week that he expects the FDA will eventually begin regulating miRNA diagnostics, in part because of other companies that “have pushed the limit of CLIA labs to where the authorities want to get a more [robust] control system in place. If that comes, we’ll certainly respond to that and make sure we obey the rules,” he said.
A more comprehensive version of this article appears in this week's RNAi News.