New Home Tests for Sexually Transmitted Diseases (STDs): What’s Changing

Original Article: https://www.medtechdive.com/news/letsgetchecked-fda-authorized-sti-test/699985/

At-Home Tests for STDs: A Big Change

Until now, the FDA only allowed at-home testing for HIV, but that’s changing. A new test called Simple 2 will let people buy it online without needing a doctor’s note. With this test, people worried that they may have an STD can collect their samples at home, send them to a lab for checking, and receive their test results online. If the results are positive or inconclusive, a healthcare provider will get in touch.

Why It Matters: Privacy and Health Information at Home

The head of the FDA’s Center for Devices and Radiological Health thinks this is a big deal for public health. He says it’ll let people learn more about their health without leaving their home. Some people might not want to get tested at a doctor’s office because they worry about privacy or find it less convenient, especially for infections like chlamydia and gonorrhea that don’t always show symptoms. This is important because, although COVID-19 made it difficult to determine the recent rates of STDs, cases of gonorrhea have been rising from 2017 to 2021.

How It Happened and What’s Next

One company, LetsGetChecked, just received the go-ahead from the FDA for this test by showing that its results agree with an already-cleared lab test. The FDA also checked that people without medical knowledge or training could use the test safely and understand the results. Now, other companies can do the same by meeting the rules set by this clearance. This could make it easier for more people to get tested for STDs, especially those that are becoming more common.