Molecular Test for Chromosomal Abnormalities Launched
Quest Diagnostics announced the launch of a new laboratory test, the ClariSure, that evaluates chromosomal abnormalities associated with 85 different developmental disorders seen in children. The launch was described in a press release shared by Quest.
ClariSure is a microarray-based comparative genomic hybridization (CGH) test. Only one blood specimen is required for the extensive analysis, which is completed by Quest. Positive findings from the CGH are generally confirmed with fluorescence in situ hybridization (FISH). Results are expected to be available to clinicians within five days of specimen receipt.
Disorders that can be detected include cri du chat, DiGeorge syndrome, mental retardation, Downs syndrome, and Williams syndrome, amongst numerous other developmental conditions. Preliminary launch plans for the ClariSure test will target pediatric and children’s hospitals and, particularly, geneticists, pediatric neurologists, and pediatricians.
CGH analysis methods entail comparison of the provided specimen DNA to healthy DNA. Using high resolution, technology can detect either missing or extra genetic material. This method of testing is considered more efficient than FISH, which would require multiple test runs to gather the same information gleaned with one microarray evaluation.
It was developed by Quest’s Nichols Institute, which directly credits the Human Genome Project for providing the key information required to develop the test. The microarray technology used in this testing is intellectual property owned by Quest Diagnostics.
The test was evaluated and validated by the scientists at the Nichols Institute. At this time, they are working to create additional tests using the same methods to identify hematological malignancies. Data thus far suggests that the tests can detect chromosomal abnormality even before abnormal cell division commences. Quest intends to market a line of ClariSure assays for these diseases in the oncology setting before the end of 2007.
September 5, 2007 Related topics: Product Launches, Diagnostic, Pediatrics