Quest Diagnostics, an in-vitro diagnostic company, has received New York State's Department of Health approval for its XSense, Fragile X with Reflex. XSense is the test for Fragile X Syndrome to be approved to employ a new laboratory analysis technique that bypasses the need to perform the Southern Blot DNA analysis method in 99% of cases.
With the approval, Quest Diagnostics offers the test to physicians in New York as well as in all other US states.
Quest Diagnostics said that the physicians can use XSense to identify carrier women who may be unaffected or slightly affected by Fragile X syndrome, but are at risk of passing it to offspring, regardless of the father’s genetics. It also aids in the diagnosis of male and female patients using blood and other specimen types.
In the study performed and funded by Quest Diagnostics, the XSense technique bypassed the need for Southern Blot in more than 99% of cases. The investigators concluded that the XSense test is highly accurate, and may be suitable for high-volume population screening and diagnostic testing on a range of patients, including women and newborns.
Charles Strom, medical director of Genetic Testing Center at Quest Diagnostics Nichols Institute, said: “New York’s approval is significant because it means a new, highly innovative genetic analysis technique for Fragile X has fulfilled state-required quality standards that are widely regarded in the lab industry as highly rigorous.
“Fragile X can be a devastating diagnosis, given the severe disability it causes many patients. While it is highly prevalent, Fragile X is not widely tested for, due in part to technical limitations with conventional tests that our XSense technique largely surmounts.”