FDA to study Rosetta Resolver for gene expression
Rosetta Biosoftware (Seattle) reported that the FDA's Center for Drug Evaluation and Research (CDER) will evaluate the Rosetta Resolver system for gene expression data management and analysis.
CDER will use the Rosetta Resolver system in the Voluntary Genomics Data Submissions (VGDS) program to analyze microarray data from sponsors. The VGDS program provides a means for sponsors to ensure that regulatory scientists are familiar with and are prepared to appropriately evaluate future genomics submissions.
CDER said it would use the Rosetta Resolver system to better understand, learn from and reproduce analyses conducted by pharmaceutical companies who voluntarily submit genomics data. In addition, the center will perform independent analyses using the Rosetta Resolver system's microarray data management and analysis tools.
Abaxis granted CLIA waiver
Abaxis (Union City, California), a manufacturer of point-of-care blood analysis systems, reported that the FDA has granted waived status under CLIA regulations for three additional analytes – ALT (alanine aminotransferase), AST (aspartate aminotransferase) and glucose – when used in conjunction with the Piccolo point-of-care analyzer.
The company said, "The significance of this waiver is that we can now approach the 20,000-plus sites currently performing waived point-of-care lipids testing and upgrade them to the sophistication and expanding capabilities of the Piccolo System. Simply put, we can offer more tests on a single panel, from a single sample, with both a cost and convenience advantage."