QIAGEN Bags FDA Clearance of NeuMoDx CT/NG Assay for Both NeuMoDx 96 and 288 Molecular Systems
Portfolio Pulse from Benzinga Newsdesk
QIAGEN (NYSE:QGEN) has received FDA clearance for its NeuMoDx CT/NG Assay 2.0, which is used for detecting bacterial infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae. This approval expands the test menu for the NeuMoDx 96 and 288 Molecular Systems in the U.S., adding to the 16 EU-certified in-vitro diagnostics tests already available in CE-IVD marking countries.
January 08, 2024 | 7:03 am
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QIAGEN's FDA clearance for the NeuMoDx CT/NG Assay 2.0 could lead to increased usage of its NeuMoDx 96 and 288 Molecular Systems in the U.S., potentially boosting sales and strengthening its position in the molecular diagnostics market.
The FDA clearance is a direct regulatory milestone for QIAGEN, likely to have a positive impact on the company's revenue as it allows them to expand their product offerings in the U.S. market. This could lead to increased sales of their NeuMoDx systems and the newly approved assay, especially given the prevalence of the infections it detects. The news is highly relevant and important to QIAGEN as it enhances their competitive edge in the molecular diagnostics space.
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