Abbott (NYSE:ABT) announced today that it received FDA clearance for its Alinity m STI (sexually transmitted infection) assay.
The Abbott Park, Illinois–based company designed its test to simultaneously detect and differentiate four common STIs: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG).
According to a news release, the first-of-its-kind multiplex test, which requires one swab sample or urine sample collected in a healthcare setting by either a clinician or patient, will help to address increasing STI rates after disruptions in the delivery of care during the COVID-19 pandemic contributed to a decline in routine STI screening.
The test runs on Abbott’s advanced, high-volume Alinity m system, a laboratory molecular instrument. The platform uses polymerase chain reaction (PCR) technology with high sensitivity in detecting infectious diseases.
“Over the past several years, STI cases have been on the rise, and we expect to see increasing rates as people resume testing after delaying during the pandemic,” Kathryn Becker, global director of scientific affairs innovation in Abbott’s diagnostics business, said in the release. “With that comes an increased need for effective and efficient testing. This four-plex STI test gives healthcare providers a more holistic picture of someone’s health in a single test, helping to support the best treatment plan to address these common STIs individually or as co-infections.”
