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.
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While the guidance encouraged the use of electronic communications in recalls, a change experts have advocated for, some questioned why the agency did not address more problems with the system.
Even after deals already eclipsed last year's numbers, analysts predict robust activity in particular among diagnostics companies flush with cash from 2020's COVID-19 test sales.
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While the guidance encouraged the use of electronic communications in recalls, a change experts have advocated for, some questioned why the agency did not address more problems with the system.
Even after deals already eclipsed last year's numbers, analysts predict robust activity in particular among diagnostics companies flush with cash from 2020's COVID-19 test sales.
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