Roche Diagnostics Assay Receives FDA Clearance for STD Testing
Roche said it has gained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for cobas CT/NG for use on the cobas 6800/8800 Systems for the detection of chlamydia and gonorrhea in both symptomatic and asymptomatic patients.
Cobas CT/NG is the first Roche Diagnostics analysis tool designed to test for sexually transmitted infections on the cobas 6800/8800 Systems, the company said. Roche said the FDA clearance marks the “first moderate complexity molecular test for sexually transmitted infections on fully automated, high throughput platform.” The assay has been cleared for use with urine samples from both males and females, as well as clinician-instructed self-collected vaginal swab specimens, clinician-collected vaginal swab specimens, endocervical swab specimens and cervical specimens collected in PreservCyt Solution, Roche announced.
“Sexually transmitted infection rates are rising worldwide and the cobas CT/NG helps labs meet increasing testing volumes with highest throughput solution on the market today,” Uwe Oberlaender, head of Roche Molecular Diagnostics said in a statement. “With exceptional performance, exemplary workflow and a flexible testing solution, the CT/NG helps labs free up staff to perform other tasks while still ensuring clinicians receive accurate and rapid results to aid in patient management.”
The Roche Diagnostic cobas 6800 and cobas 8800 Systems have been available since 2014. The systems provide up to 96 results in about 3 hours and a total of 864 results for the cobas 6800 System and 1,824 results for the cobas 8800 System within eight hours, the company said.
Chlamydia trachomatis is the most common bacterial Sexually Transmitted Disease and Neisseria gonorrhea is the second most common. Roche said the new test for most common sexually transmitted infections complements an existing menu that includes tests for viral load monitoring and donor screening
Barbara Van der Pol, an expert on sexually transmitted infections, said the Roche Diagnostics assay provides clinicians with strong results due to the “excellent sensitivity and specificity of the assay for all relevant sample types.”
“For the laboratory, the platform provides a tech-friendly solution that minimizes hands-on time while maximizing the flexibility of incorporating sexually transmitted infection screening with other assays that are currently available on the system,” Van der Pol said in a statement.
Roche said that other STI assays are in development to include HIV. Additionally, the testing will also include Hepatitis B and C and Cytomegalovirus, as well as MPX, WNV, DPX and Zika for use in screening blood donations.