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BioWorld - Thursday, May 21, 2026
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Home » FDA gives nod to Asuragen’s Amplidex Fragile X Dx and Carrier Screen Kit
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FDA gives nod to Asuragen’s Amplidex Fragile X Dx and Carrier Screen Kit

Feb. 24, 2020
By Liz Hollis
Asuragen Inc., an Austin, Texas-based molecular diagnostics company, has received good news from the U.S. FDA. The agency gave the green light for the company’s Amplidex Fragile X Dx and Carrier Screen Kit, which aims to detect a genetic condition known as Fragile X syndrome. The diagnostic kit determines the number of cytosine-guanine-guanine (CGG) repeats in the FMR1 gene to aid in the diagnosis of Fragile X syndrome and associated disorders, including Fragile X-associated tremor/ataxia syndrome and Fragile X-associated primary ovarian insufficiency.
Medical technology Regulatory Diagnostics De novo FDA

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