FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits

For the first time, the FDA has issued marketing clearance for a lab test detecting gonorrhea and chlamydia that relies on samples users collect at home. Previously, HIV was the only sexually transmitted infection (STI) for which the agency had cleared at-home sample collection. The De Novo authorization opens up a new, wider market for STI direct-to-consumer (DTC) tests and kits. And with nationwide STI cases continuing to climb to levels not seen in decades, the new in vitro diagnostic (IVD) authorization comes at an opportune moment.

FDA greenlights at-home collection kits for chlamydia and gonorrhea

There were more than 2.5 million reported STI cases in the US in 2021, according to the US Centers for Disease Control and Prevention (CDC).¹ Chlamydia and gonorrhea accounted for over 2.3 million of them, with each disease creeping up 4 percent compared to the previous year. Gonorrhea rates have increased 118 percent since 2009. Chlamydia is the most prevalent STI in the US with over 1.6 million cases reported in 2021.²

On November 15, the FDA announced that the Simple 2 Test from LetsGetChecked had become the first diagnostic test for chlamydia and gonorrhea with at-home sample collection to receive marketing authorization. The test is available online without a prescription for $99 USD. It comes with equipment and instructions enabling users to collect a urine sample or vaginal swab that’s sent to a lab for testing. Users also complete a questionnaire providing information about their health for use by a clinician. Test results are delivered online, and a clinician then follows up with the user to discuss further testing and treatment options if the test comes back positive or invalid.³

Significance of the new clearance

The LetsGetChecked authorization is likely to have a significant and positive impact on the STI lab testing market, particularly the larger market segment that focuses on screening, as opposed to tests for patients with symptoms, says Donna Hochberg, partner with Massachusetts-based consulting firm Health Advances.  

All of the STI screening tests on the market are technically LDTs. Until now, no at-home sample collection device had secured IVD clearance. The new clearance future-proofs these tests if new FDA regulations take effect and all LDTs will have to be approved by the agency, explains Hochberg, who is leader of Health Advances’ Diagnostics and Life Sciences Tools practice. The approval also bolsters test makers’ attempts to persuade consumers to buy, and payers to reimburse, their products.

While at-home testing and sample collection generally makes testing more convenient, there are also significant privacy ramifications in the realm of STIs. Until now, individuals who suspected they might have chlamydia or gonorrhea had to go to their doctor’s office to get tested. At-home sample collection allows for testing without a physician visit. This could significantly increase utilization and treatment.

Business ramifications

In clearing the LetsGetChecked test, the FDA also created a pathway that other companies can follow to secure De Novo and 510(k) marketing clearance for their own at-home sample collection STI products. The FDA announcement notes that the agency is establishing a template defining the labeling and performance controls which, in combination with general controls, “provide a reasonable assurance of safety and effectiveness for tests of this type.”³ Companies will then be able to use the 510(k) pathway to bring at-home-sample-collection-based STI tests to market by demonstrating their substantial equivalence to a predicate device.

Test makers will also get a boost from the recent surge in consumer awareness of home testing products since the COVID-19 pandemic. “Consumers discovered via COVID rapid antigen testing that they could collect their own samples, run their own tests, and get results in minutes without having to leave their homes,” Hochberg explains.

However, Hochberg also cautions STI screening test makers not to celebrate just yet, citing major barriers, especially payer reluctance to cover the tests. “Most of the current STI screening testing is self-pay.” In that sense, she compares the emerging self-collection and self-test STI market to that for consumer genetic test products.

References:

1. 1. https://www.cdc.gov/media/releases/2023/s0411-sti.html

1. 1. https://www.cdc.gov/std/statistics/2021/tables/1.htm

1. 1. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-test-chlamydia-and-gonorrhea-home-sample-collection

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Here are the key new FDA clearances that were announced in the period from early October through mid-November 2023:

New FDA Approvals and Emergency Use Authorizations (EUAs)

New CE Marks and Global Certifications

Notable European CE certifications announced during the period:

New Approvals in Europe

Other international clearances announced during the period: