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First Test For Chlamydia And Gonorrhea With At-home Sample Collection Receives FDA's Marketing Authorization

USA: The U.S. Food and Drug Administration (FDA) has granted marketing authorization to to the first chlamydia and gonorrhea test that allows for at-home sample collection.

The Simple 2 Test is available over-the-counter (OTC) and is intended for use in adult patients ages 18 years and older. It is the first FDA-authorized test with at-home sample collection for any sexually transmitted disease other than HIV.

Prior to the authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor's office.

"This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home."

According to the Centers for Disease Control and Prevention's Sexually Transmitted Infections Surveillance Report, chlamydia and gonorrhoea are the first and second most common bacterial sexually transmitted infections (STI) in the United States, and the rate of these STIs is steadily increasing, with an estimated 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhoea, in 2021 alone.

Typically, both infections can be easily treated, but if left untreated, both infections can cause serious health complications for patients, including infertility. Expanding the availability of STI testing can help patients get quicker results and access to the most appropriate treatment, ultimately helping to curb the rising rates of STIs.

The Simple 2 Test which uses vaginal swabs or urine specimens, as appropriate, can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause chlamydia and gonorrhea, respectively.

The test is a direct-to-consumer test that can be purchased without a prescription. The user activates the collection kit online and fills out a health questionnaire for a health care provider to evaluate. The individual collects the specimen at home using the provided collection kit, which is then sent back to the designated laboratory for testing. Results are delivered online, with follow-up from a health care provider in cases of positive or invalid test results.

The Simple 2 Test includes the Simple 2 Home Collection Kits that were validated for use with the cleared Hologic Aptima 2 Combo Assay. The FDA also evaluated data from LetsGetChecked demonstrating lay users can safely use the kit and have a general understanding of the results and any necessary follow up actions and validated their home collection kits with the intended test.

The risks associated with the test are mainly the possibility of false positive and false negative test results. False negative test results can result in delays to effective treatment, progression to disseminated disease, and spread of infection to other persons throughout your community. If exposed to a person with either gonorrhea or chlamydia, CDC guidelines indicate that you should be treated by a healthcare provider with antibiotics, regardless of the test result.

False positive results could lead to an inappropriate diagnosis of, and unnecessary treatment for chlamydia and gonorrhea, respectively. This could lead to psychological distress, delay in receiving a correct diagnosis as well as the expense and risk for side effects from unnecessary treatment.

The FDA reviewed the Simple 2 Test under the FDA's De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.

This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA's 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device, which may save a developer time and expense compared to other review pathways.

You Can Now Test For Chlamydia And Gonorrhea With An At-Home Kit

Key Takeaways

The FDA granted marketing authorization for the first at-home test for chlamydia and gonorrhea.

The test, called Simple 2, is the first FDA-authorized at-home test kit for STIs other than HIV.

Experts say the authorization expands public accessibility and flexibility for testing STIs, particularly benefiting communities that have low access to sexual health clinics.

The Food and Drug Administration (FDA) authorized the first at-home sample-collection test for chlamydia and gonorrhea. Adults can now buy the test over the counter (OTC) without a doctor's prescription.

The test, called Simple 2, is made by the virtual health company LetsGetChecked.

Previously, the only approved tests for chlamydia and gonorrhea required samples to be collected on-site, such as at a provider's office. According to the FDA, Simple 2 is the first test with at-home sample collection for sexually transmitted infections (STIs) other than HIV.

Chlamydia and gonorrhea are the two most common STIs in the United States. Both of these infections are increasing, with an estimated 1.6 million chlamydia cases and more than 700,000 gonorrhea cases reported in 2021, according to the Centers for Disease Control and Prevention (CDC).

These STIs are easily treatable, but people don't always know they are infected. If left untreated, both STIs can have severe health consequences, including infertility.

Making STI testing more accessible can help patients get their results faster and seek treatment, the FDA said.

"This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home," Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in a press release. "We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home."

What Does This Mean for STI Testing? The marketing authorization for Simple 2 will broaden public access and flexibility for STI testing, said Monte Swarup, MD, FACOG, a board-certified OB/GYN in Chandler, AZ and the founder of Vaginal Health Hub. This is especially important, he said, for people living in rural areas that don't have healthcare providers, telehealth services, or accessible clinics nearby. "The FDA approval gives the public the ability to collect their specimens from home and provides greater accessibility and flexibility," Swarup said. "This expands the potential for home health care." How Does the Simple 2 Test Work? For the Simple 2 test, a patient self-collects their specimen within the safety, convenience, and privacy of their own home, Robert Mordkin, MD, chief medical officer of LetsGetChecked, told Verywell. People with a vagina take a vaginal swab and those with a penis give a urine sample, Mordkin said. Once the sample is collected, a patient sends their specimen to a designated LetsGetChecked lab for testing. The kit comes with a prepaid, pre-addressed packet for overnight shipping. "The specimen is processed and analyzed on FDA-approved equipment, and the results are quickly provided directly to the individual via their LetsGetChecked app," said Mordkin. Once their specimen has been shipped out, a patient can expect to get results within two to five days. For positive results or invalid tests, the company offers patients follow-up support and treatment discussions with their team of physicians, nurse practitioners, and nurses. However, the follow-up consultations and prescribed medications are not included in the cost of the test. How Much Does Simple 2 Cost? You can order a Simple 2 test online through the LetsGetChecked website or app. Before you can get a test, you need to fill out a brief health questionnaire. It will be quickly reviewed by the company's medical team so that a "prescription" for the test can be generated. "There is no need to get a prescription from an outside source," Mordkin said. A single Simple 2 test kit costs $99 out-of-pocket. You can also subscribe and pay $69.30 to receive a test every 3 months, $79.20 for every 6 months, or $84.15 for every 12 months. Currently, the Simple 2 test is not eligible for insurance coverage. However, Mordkin said that the company does accept many Flexible Spending Account (FSA) and Health Savings Account (HSA) cards. "We do not accept insurance at this time. We work to keep our tests as affordable as possible, and our test costs are generally lower than the costs incurred from a trip to a healthcare provider," Mordkin said. Out-of-pocket costs for STI tests given at home or through a health provider can range from $50 to more than $300, depending on the company and how many diseases the product tests for. While many insurance plans will cover the cost of preventive STI screening and the healthcare provider's visit fee, the cost to the patient will depend on their plan. Insurers may pay for one STI test per year, they may cover some of the cost and require a co-pay, or they may cover testing for some STIs but not others. Other Ways to Get STI Testing You can also get tested for chlamydia and gonorrhea at a healthcare provider's office, a community health clinic, or your local health department. In some states, you might have the option of an online visit with a provider along with at-home testing. Many local clinics and Planned Parenthood health centers offer inexpensive or free STI testing. You can call ahead to learn if you are eligible for free testing. "STI testing is available and may be more cost-effective if health insurance covers testing via your physician or more cost-effective through the county health department," said Taylor Nelson, DO, an assistant professor of clinical medicine at the University of Missouri School of Medicine and Medical Director, MU Infection Control, at MU Health Care, told Verywell. If you're not sure where to get STI testing, your state's public health department and your provider's office are two places to ask first. What This Means For You You can take an at-home test for chlamydia and gonorrhea without a prescription requirement. You'll need to pay out-of-pocket for the test and any follow-up care and treatment you get from LetsGetChecked. The Simple 2 test may give a false negative test, the FDA said. If you're exposed to a person with gonorrhea or chlamydia, you should see a healthcare provider for antibiotic treatment and further care, regardless of the test result.

First At-Home Test For Chlamydia And Gonorrhea Authorized By FDA

The FDA on Wednesday granted marketing authorization to the first chlamydia and gonorrhea test that allows for at-home sample collection.

Intended for adults, the over-the-counter (OTC) Simple 2 test marks the first home diagnostic for sexually transmitted infections (STIs) outside of those for HIV.

"This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home," Jeff Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health, said in a statement.

The move comes as cases of chlamydia and gonorrhea, the two most common bacterial STIs, have exploded in recent years. In 2021 alone, the U.S. Recorded roughly 1.6 million chlamydia cases and 710,000 gonorrhea cases, according to the CDC.

Left untreated, the STIs can cause serious complications, but in most cases a course of antibiotics will resolve the infections. The agency expects the home test to help patients get quicker access to treatment and help curb the spread.

At-home collection for the Simple 2 test involves either a vaginal swab or urine specimen to detect the bacteria causing the infections, Chlamydia trachomatis and Neisseria gonorrhoeae. After filling out a questionnaire, the specimen is sent back to maker LetsGetChecked's CLIA- and CAP-certified laboratory, with results delivered online after 2 to 5 days, the company said. Follow-up with a healthcare provider is offered in the cases of a positive or invalid result.

According to FDA, studies performed by the developer showed that individuals understood how to use the testing kits and how to interpret the results.

"Risks associated with the test are mainly the possibility of false positive and false negative test results," the agency said.

Authorization of the Simple 2 test under the de novo premarket review pathway will open the door to similar tests that prove equivalence under the agency's 510(k) pathway, the FDA said.

Ian Ingram is Managing Editor at MedPage Today and helps cover oncology for the site.

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