Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced receiving approval from the US Food and Drug Administration (FDA) and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels. This marks a significant advancement in rapid diagnostic capabilities for STIs.
Product Details and Technology
The cobas liat STI multiplex assay panels feature gold-standard polymerase chain reaction (PCR) technology, delivering results in 20 minutes or less. The product is expected to launch in the US market in the coming months and is designed for the detection of gonorrhea and non-gonococcal urethritis (CT/NG), as well as gonorrhea, non-gonococcal urethritis, and mycoplasma genitalium (CT/NG/MG). This enables clinical doctors to diagnose and distinguish multiple sexually transmitted infections based on a single sample, enhancing diagnostic efficiency and accuracy.
Future Outlook
With FDA approval and CLIA waiver in hand, Roche is poised to introduce its cobas liat STI multiplex assay panels to the US market, offering healthcare providers a rapid and reliable diagnostic tool for sexually transmitted infections. This development underscores Roche’s commitment to advancing diagnostic solutions in the field of infectious diseases.-Fineline Info & Tech
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