FDA clears Abbott test to spot 4 STIs at once amid soaring case rates

FDA clears Abbott test to spot 4 STIs at once amid soaring case rates

The prevalence of sexually transmitted infections, or STIs, has long been considered an epidemic—and those rates are rising. In each of the six years between 2014 and 2019, STIs reached increasingly higher all-time levels in the U.S., according to data from the Centers for Disease Control and Prevention (CDC), which also estimates that about 1 in 5 Americans has an STI.

The COVID-19 pandemic further exacerbated the issue, as hospitals closed to nonessential procedures and clinics shifted their resources to focus on testing for the coronavirus. In 2020, the most recent year for which the CDC has published data, rates of both gonorrhea and syphilis were higher than in 2019. And while the number of reported chlamydia infections dropped, the agency was skeptical of that change, attributing it to pandemic-induced reductions in screening and diagnosis.

Recent efforts to mitigate the growing STI epidemic include the state of California’s plan to make at-home tests reimbursable by private insurers and, as Abbott announced Wednesday, the FDA’s clearance of a single test that can detect four infections at once.

Abbott’s assay runs on its Alinity m molecular PCR platform. Using just one swab or urine sample, it simultaneously tests for several bacteria: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium, which cause, respectively, chlamydia, gonorrhea, trichomoniasis and both urethritis and cervicitis.

By looking for multiple infections at once, the assay “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,” according to Kathryn Becker, Ph.D., global director of scientific affairs innovation in Abbott’s diagnostics division.

The test has been cleared by the FDA to analyze samples collected by either a clinician or the patient themselves in a healthcare setting, but Becker said that Abbott is looking into bringing its STI diagnostics into the home.

“The pandemic showed us the value of having aspects of testing available to people in their homes,” she said. “As we look to the future of testing, we will be focused on bringing that kind of convenience and discretion for STIs and other conditions.”

Abbott’s Alinity m platform can report results within about two hours and can analyze as many as 300 samples in the span of eight hours.

The addition of the STI test brings the tally of assays cleared to run on the platform to six. In addition to landing full FDA clearances of its tests for HIV-1, hepatitis B andhepatitis C, Abbott was also granted emergency use authorization for a pair of PCR tests for COVID, including one solely for the virus and another four-in-one assay that detects COVID, two types of influenza and respiratory syncytial virus.

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