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FDA approves Abott's STI test that detects multiple organisms simultaneously

DTMT Network

Global pharmaceutical major Abbott has recently announced that it has received clearance for its Alinity m STI Assay from the United States Food and Drug Administration (FDA).

In a statement, the company said that the test simultaneously detects and differentiates four common sexually transmitted infections (STIs).

The test, which is a first-of-its-kind multiplex test will help address increasing STI rates in the United States, after disruptions in delivery of care during the pandemic contributed to a decline in routine STI screening and an increase in cases, the company informed.

The Alinity m STI test for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium requires only one swab sample or a urine sample and runs on Abbott's Alinity m system, which uses polymerase chain reaction (PCR) technology, Abbott said.

“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,” said Dr Kathryn Becker, global director of scientific affairs innovation in Abbott's diagnostics business.

“This four-plex 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,” she added.

It may be noted that the United States Centers for Disease Control and Prevention estimates that 20% of the population of the country suffers from STIs and the numbers are growing each year, with cases of gonorrhoea, chlamydia and syphilis touching an all-time high.

“The pandemic showed us the value of having aspects of testing available to people in their homes,” said Becker, while discussing the future scenario of development in the field.

“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,” she added.

 


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