Dive Brief:
- Abbott received FDA clearance for a molecular PCR assay that detects and differentiates four common sexually transmitted infections.
- The FDA clearance covers Abbott’s Alinity m STI Assay, a multiplex test for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG). The assay is designed to detect the pathogens in one swab or a urine sample.
- Abbott is pitching the assay as a way for healthcare providers to gain a fuller picture of a person’s health from a single test to set up the optimal treatment plan for whichever STIs or co-infections the individual has.
Dive Insight:
STI cases overall have been on the rise in the U.S. Cases of gonorrhea, the sexually transmitted disease caused by NG, rose 45% from 2016 to 2020. While cases of chlamydia, the disease caused by CT, fell 1.2% over the same period, that's mostly attributed to a 13% drop in 2020 that the CDC said “is likely due to decreased STD screening and underdiagnosis during the pandemic, rather than a reduction in new infections.”
Against that backdrop, Abbott has identified a need for more effective and efficient testing. The Alinity m STI Assay is intended to address that need by equipping healthcare providers to determine which STI a patient has using a single sample. Accurate diagnosis of the STI is needed to inform optimal treatment.
Researchers outside of the U.S. previously have found Abbott’s Alinity m STI Assay can meet the need for accurate diagnosis of STIs. In one study, Abbott collaborated with a Brazilian clinical diagnostics company to show the test achieved positive and negative agreements of about 94%, and in many cases 100%, for all the tested pathogens, regardless of whether urine or gynecological samples were used.
Abbott now will bring the assay to the U.S. market, seeking to carve out a piece of the market with a product that it sees as a “first-of-its-kind multiplex test” that “provides fast results in high volumes.” As it enters the market, Abbott will compete with companies including Hologic.
Hologic became the first company to receive the green light from the FDA to sell a test for MG in the U.S. in 2019, clearing the way for other businesses to come to market via the 510(k) pathway. The company’s line of Aptima STI products includes a multitest swab that enables users to run four tests in one tube to detect up to seven infections from one vaginal swab. Hologic’s tests run on its Panther system.
