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Will First FDA-approved At-home Test For Gonorrhea, Chlamydia Ease The Epidemic?
The Food and Drug Administration's first-ever approval of an at-home test for chlamydia and gonorrhea could help drive earlier detection and treatment of these sexually transmitted infections amid a ballooning epidemic in the U.S. But some sexual health advocates worry that the FDA's proposal to begin stepping up regulation of over-the-counter self-testing of STIs could backfire.
The need for new tools to combat these infections is dire.
Diagnoses of gonorrhea, chlamydia and syphilis have soared in the past two decades. Public health experts argue that this is at least partially driven by woeful long-term flat funding of the Centers for Disease Control and Prevention's budget to fight the spread of STIs during this period.
Some public health officials and advocates expect that greater FDA oversight will help legitimize home STI testing, making it easier to get insurance coverage and actually expanding its use.
Other home tests for these three bacterial STIs are already available over the counter. But the FDA, which has not previously sought to enforce regulation or require that their manufacturers apply for formal approval, cannot vouch for their accuracy.
A consortium of LGBTQ sexual health advocates has objected to a recent FDA policy proposal that, if enacted, would require the companies already offering at-home medical tests, including for STIs, obtain regulatory approval. A central worry is that the expense of meeting the FDA's demands could drive some companies out of the STI self-testing market and otherwise drive up the cost of the tests.
There are also concerns that the newly approved test does not cover syphilis and is not well suited to address gay and bisexual men's needs.
The test kit, called Simple 2, does not screen for syphilis, which typically requires at least a finger-prick blood sample. There were at least 177,000 syphilis cases in 2021, a 74% increase since 2017, according to the CDC. Most concerningly, CDC data shows that rates of syphilis in newborns, which can be fatal, rose more than tenfold in the past decade.
Dr. Boghuma Titanji, an infectious disease specialist at Emory University, said that the inconvenience of having to go into a clinic was a major barrier to getting at-risk people tested for STIs.
"Just remove that requirement, that will make the access better for a lot of patients," she said.
Dr. Leandro Mena, director of the Division of STD Prevention at the Centers for Disease Control and Prevention, believes the new at-home test's approval will indeed increase testing for gonorrhea and chlamydia.
Self-testing, he said, provides "a tremendous opportunity to empower people to control when, where and how they get tested, and how they learn about their test result, so they can get appropriate treatment for these STIs."
Chlamydia and gonorrhea are the most common STIs in the U.S., diagnosed in 1.6 million and 710,000 people respectively in 2021, according to the CDC. They can often be asymptomatic and are easily cured with antibiotics. However, if left untreated, the infections can lead to infertility and can be especially harmful to women, leading, for example, to pelvic inflammatory disease. They spread disproportionately among adolescents and young adults, gay and bi men, and people of color.
Will FDA oversight help or hinder the STI fight?On Nov. 15, the FDA granted marketing authorization for adults to use the over-the-counter Simple 2 Test for gonorrhea and chlamydia, from the home-testing company LetsGetChecked. The test kit, currently sold for $99 through the company's website, can be activated online, where the consumer fills out a health questionnaire before shipping in samples to a laboratory.
If the results are positive, the company would then put the individual in contact with a physician.
Previously, HIV was the only other sexually transmitted infection to have an FDA-approved at-home test.
Other at-home STI tests are available through telemedicine companies and major pharmacy chains. However, these tests exist in a legal gray zone. Because they're based on samples that are not taken in a lab, they don't qualify for an exemption from requiring FDA approval that the agency grants to so-called laboratory-developed tests.
The FDA has generally not sought to exert control over home-based tests. However, on Sept. 29, the agency opened a two-month public comment period on a proposed new plan to require companies offering medical self-testing kits for any purpose to seek formal marketing authorization for their products. The FDA's move followed reports of faulty self-tests that led to undertreatment or improper treatment for heart disease and cancer.
The goal, according to the FDA, is to "ensure the safety and effectiveness of these tests."
In response, a group that includes sexual health advocates and owners of gay dating apps that provide free at-home HIV and STI testing, began circulating a petition that calls for the FDA to exempt such public health programs from the proposed new demands. Gaining approval for existing STI tests, the petition states, would involve a "time-consuming and expensive process."
"Many public health leaders are concerned that new FDA regulations will create additional barriers to public health testing," said Jen Hecht, director of the consortium Building Healthy Online Communities.
Dr. Matthew Golden, who leads the HIV and STI control program at Seattle's public health department, said that the FDA is playing catch-up in an effort to enforce regulation of an industry that has grown fast since Covid.
"At some level, the horse has left the barn," said Golden, noting that self-testing kits have been widely used for years. However, he said that for "some of those tests, how well they perform is not well known. So cleaning this up makes sense."
A source familiar with FDA policies and practices told NBC News that if the agency decides to demand that self-testing companies obtain regulatory approval, it would not likely interrupt the availability of existing medical self-tests during the application process.
That said, it is likely that once a critical mass of self-testing companies obtained or otherwise sought approval, the agency would go after any laggards.
Gay men's needs are left out — for nowThe Simple 2 Test is effectively geared only toward STI exposures from vaginal intercourse.
The kit can process a urine sample and a swab of the vaginal area. Chlamydia and gonorrhea infections, however, can be localized in the throat, urogenital area or rectum. A urine sample can detect urogenital infections in men and women. For people who may have otherwise been exposed through oral or anal sex, oral and rectal swabs would also be needed.
David Harvey, executive director of the National Coalition of STD Directors, said that public health experts "expect and need" the FDA ultimately to approve at-home tests for syphilis and for oral and rectal gonorrhea and chlamydia infections, "so we're also reaching others who are at high risk, including gay men."
The CDC's Mena said he hoped that the agency and the FDA will confer with LetsGetChecked or other testing companies about pushing for additional approvals.
The FDA's authorization for the Simple 2 Test was based on data indicating that consumers could successfully use the home tests, understand the results and then take any necessary subsequent action.
It's unclear whether the test will be available outside LetsGetChecked website or whether $99 kit will be covered by insurance. The company didn't respond to requests for comment.
Tristan Schukraft, CEO of MISTR, a telehealth company that provides the PrEP HIV prevention pill, is supportive of greater FDA oversight of home tests, but expressed concern that tighter regulation could increase the cost of testing.
"Labs are going to be required to spend additional money and resources on studies, quality systems, reagents and software systems," Schukraft said.
In addition, MISTR requires that PrEP recipients undergo testing every three months for chlamydia, gonorrhea and syphilis. At least 85% of MISTR customers on PrEP opt for at-home testing. The company advises people who test positive — about 13.5% of the kits detect at least one STI — to seek medical care and provides assistance in connecting people to care for those who need it.
Schukraft suggested that greater regulation could lead companies to pull such tests from the market.
If so, he said, "the FDA would be doing harm to public health."
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FDA Authorizes First At-Home Test For Chlamydia, Gonorrhea: What To Know
The Food and Drug Administration (FDA) recently approved the first at-home test for three common sexually transmitted infections and diseases that can be purchased without a prescription.
The test is designed for females with or without symptoms of these three infections. Results are delivered within 30 minutes.
Visby officials told Healthline they expect the new test to be available in a few months and will announce pricing then.
The Visby product is a single-use test that includes a collection kit (vaginal swab) and a powered testing device that communicates with the Visby Medical App. The app displays results when the test is complete.
FDA officials reported that in recent clinical studies the Visby at-home test correctly identified more than 98% of negative samples for the three STDs and more than 97% of positive samples.
The FDA reviewed the product under the agency's De Novo premarket review pathway, which allows low-risk to moderate-risk devices to be approved quickly. This authorization also allows other devices to go through the FDA's 510 (k) premarket notification process for quick approval by proving their similarity to the Visby product.
"This approval is not just a milestone for Visby Medical but marks a transformative moment in medical diagnostics," said Adam de la Zerda, PhD, founder and chief executive officer of Visby Medical, in a press statement.
These tests are specific to these individual infections and involve collecting blood and/or urine samples. The products include the Visby Medical Sexual Health Test, which lacks the app that the new product contains.
In its annual surveillance report released last year, the CDC also reported there were more than 200,000 cases of syphilis diagnosed in the U.S. In 2022, the highest number since 1950.
Experts say at-home tests are important because people with STIs need to seek medical treatment quickly. Antibiotics are effective in treating these infections, but untreated STIs may lead to serious health issues, including infertility.
They add that test accuracy is also important because a false negative result can delay treatment. A false positive result can lead to unnecessary treatments and a potential delay in correctly diagnosing another infection or disease.
"Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment," said Courtney Lias, PhD, the director of the Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health, in an FDA press release.
"Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection."
Lisa Valle, DO, OB-GYN and medical director of Oasis Women's Sexual Function Center in Santa Monica, CA, said at-home kits have the ability to increase the number of people who test for STDs.
"More people are apt to test in the privacy of their homes," Valle told Healthline.
She noted that increased testing can help reduce the spread of STDs and lead to earlier treatments.
She does caution, however, that a person can receive a positive result while alone in their home without anybody to talk to or counsel them.
"There are medical and emotional issues they could be dealing with without the help of a healthcare professional," she said.
Valle added that there are potential issues for someone who receives a negative test result at home. They can be satisfied there isn't anything wrong with them despite having symptoms and not getting tested for other illnesses or conditions.
Some — but not all — STIs can develop into a sexually transmitted disease (STD). These diseases do produce symptoms in many people.
All can be diagnosed with basic tests and treated with antibiotics.
Chlamydia is usually transmitted through oral, vaginal, or anal sex without a condom or other barrier protection.
Some people who have chlamydia don't have symptoms. When symptoms do appear, they can include:
Gonorrhea can affect anybody, but it is most common among teens and young adults between the ages of 15 and 24.
It is also transmitted through oral, vaginal, and anal unprotected sex.
Symptoms usually appear 2 to 30 days after exposure. They include:
Trichomoniasis causes symptoms in only about 30% of people with the disease.
When symptoms do appear, they include:
Valle said it is that important people get tested either at home or in a medical facility if they develop these symptoms.
She recommends that people get tested before and after they get involved with a new romantic partner.
"Overall, testing does help decrease the spread of these diseases," she said.
There's Now An At-Home Test For Chlamydia And Gonorrhea
Americans looking to stay on top of their sexual health have a new at-home option available to them. Earlier this month, the Food and Drug Administration authorized the first home test for chlamydia and gonorrhea. Developed by the company LetsGetChecked, the Simple 2 test costs between $58 and $99 a kit and returns results within a week.
Chlamydia and gonorrhea are both caused by bacteria. Though there are other more prevalent STIs in the population, such as HPV, chlamydia and gonorrhea are the most commonly reported STIs in the U.S. And other countries. These infections can cause acute symptoms like genital discharge, painful or burning urination, and bleeding between periods; left untreated, they can also raise the risk of infertility and pregnancy complications.
It can be difficult to manage STIs, in part because they often don't cause noticeable illness. So the less that sexually active people are getting screened for STIs, the more likely that any given infection can spread to many others before it's finally noticed. Annual STI cases have continued to rise in the U.S. In recent years, with an estimated 1.6 million cases of chlamydia and more than 700,000 cases of gonorrhea in 2021. Experts generally agree that more accessible testing is needed to stem the tide of America's STI crisis.
"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, director of the FDA's Center for Devices and Radiological Health, in a statement released on November 15. "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."
The Simple 2 test can already be purchased now from the company's website. The kit comes with tools for collecting urine specimens or vaginal swabs, which are then sent to a testing lab via a prepaid shipping label. Users are also asked to fill out an online questionnaire. After two to five days, the results will be available to view online, and people can arrange a virtual consultation with a health care provider through the company to obtain antibiotic treatment if they test positive.
The Simple 2 test's list price is $99 dollars with free shipping. It's currently discounted at $84, however. And people can sign up for a subscription service where they receive a test every three months for $58.80 a kit. The company also sells other, more expensive at-home tests that cover up to eight STIs, including HIV and syphilis.
While this is the first home test authorized in the U.S. For these STIs, LetsGetChecked may soon have some competition. This fall, the UK-based start-up Daye launched its own at-home STI screening service, albeit one that uses a specially designed tampon as its diagnostic tool. The tampon test is only available in the UK right now, but the company plans to seek regulatory approval in the U.S. And greater Europe in the near future.
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