FDA Authorizes First At-Home Test for Syphilis
📰🚨Extra, Extra!🚨📰
The FDA recently authorized the first at-home, over-the-counter test for syphilis.
The test, developed by @nowdx, is expected to be available later this year for around $30.
You may recall the FDA’s recent approval late last year for the first OTC, at-home chlamydia a gonorrhea test. There is also an FDA-approved, at-home HIV test.
So this begs the question, aren’t there other available at-home testing kits? Does this mean they’re somehow bad or less reliable?
Not exactly.
FDA authorization means that “… the product’s safety and effectiveness have been reviewed by the FDA and the product’s known and potential benefits outweigh the known and potential risks.” (FDA)
Self-testing kits have been available for some time, with popularity increasing following the COVID-19 pandemic. FDA authorization offers a layer of consumer protection, but STI self-test kits shouldn’t be dismissed, especially when considering understaffed clinics, access to care, and stigma around testing.
It’s also important to note that the FDA encourages more companies to pursue approval for at-home tests, but the cost of obtaining FDA approval is often costly, ranging from millions to billions of dollars depending on the product and market (BrightFocus Foundation, 2021).
Given the current rise of syphilis (reaching rates we haven’t seen since 1950), I think increasing availability and accessibility is a great step. But it’s not the only step.
If you’re interested in learning more about this approval, what it means, and how to combat rising rates of syphilis, you can read more on my Substack.