Roche’s Cobas TV/MG Test Receives FDA’s 510 (k) Clearance for the Detection of Sexually Transmitted Diseases

Shots:

• Roche has received 510(k) clearance for its Cobas TV/MG test runs on Cobas 6800/8800 System to detect Trichomonas vaginalis (TV) and/or Mycoplasma genitalium (MG) DNA in both symptomatic and asymptomatic patients
• The addition of Cobas TV/MG test expands the testing menu on the Cobas 6800/8800 Systems and has been validated to use with multiple specimens including male/female urine, endocervical swabs and vaginal swabs
• The combination of Cobas TV/MG with Cobas Chlamydia trachomatis (CT)/ Neisseria gonorrhoeae (NG) based on PCR technology, used for the detection of CT & NG, providing high throughput solutions supporting the molecular testing needs

Click here to read full press release/ article | Ref: Roche | Image: Behance