Abbott Gets FDA’s 510(k) Clearance for Test for Four Common STDs

Abbott has received the FDA’s 510(k) clearance for its Alinity m STI assay, which detects and differentiates between four common sexually transmitted infections (STIs).

The polymerase chain reaction (PCR) assay, which can identify chlamydia, gonococcus, trichomonas vaginalis and mycoplasma genitalium, runs on Abbott's Alinity m high-volume molecular analysis equipment

The multiplex test will help address increasing STI rates after disruptions in care during the pandemic contributed to a decline in routine STI screening, the company said.