Roche: STI test panels approved by FDA
(CercleFinance.com) - Roche reports that the US FDA has granted 510(k) clearance and CLIA (Clinical Laboratory Improvement Amendments of 1988) waiver for its multiplex sexually transmitted infection (STI) point-of-care testing panels.
These panels, comprising tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and genital mycoplasma (CT/NG/MG), enable clinicians to diagnose and differentiate between multiple STIs using a single sample.
These tests use highly sensitive, gold-standard PCR technology, providing results in 20 minutes. They will be available exclusively on the US market in the coming months, with CE-marked commercialization to follow shortly.
Copyright (c) 2025 CercleFinance.com. All rights reserved.
These panels, comprising tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and genital mycoplasma (CT/NG/MG), enable clinicians to diagnose and differentiate between multiple STIs using a single sample.
These tests use highly sensitive, gold-standard PCR technology, providing results in 20 minutes. They will be available exclusively on the US market in the coming months, with CE-marked commercialization to follow shortly.
Copyright (c) 2025 CercleFinance.com. All rights reserved.