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Abbott Nabs FDA Clearance for Multiplex Molecular STI Panel

NEW YORK – Abbott announced on Wednesday that its multiplex sexually transmitted infection panel has received clearance from the US Food and Drug Administration.

The Alinity m STI Assay detects and differentiates between Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium from a swab or urine sample collected in a healthcare setting. 

The test is cleared for use on Abbott's Alinity m PCR platform, which can run up to 1,080 tests in 24 hours. The firm also offers hepatitis B and C, HIV-1, and SARS-CoV-2 tests on the instrument, as well as a multiplex respiratory panel.

"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 a statement. "With that comes an increased need for effective and efficient testing." 

The 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."