As STDs grow, companies rush to market at-home testing devices. – Lake County Record-Bee

Among the more remarkable legacies of the covid-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved for at-home testing to become a trusted tool for managing the public health crisis.

But that focus is quickly lost from another epidemic, less publicized: the explosion of sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has fueled calls from researchers, public health advocates, and health care companies to urge the federal government to stock up on home testing kits that could multiply the number of Americans tested for STDs.

Online shoppers can already choose from more than a dozen self-testing devices, typically priced from $69 to $500, depending on the brand and the type of infection it can detect.

However, except for HIV tests, the Food and Drug Administration has not approved STD test kits for use outside of a medical setting. That leaves consumers unsure about their freedom even as home use increases dramatically.

The STD epidemic is “out of control,” said Dr. Amesh Adalja, a senior scholar at Johns Hopkins University’s Center for Health Security. “We know we’re missing diagnoses. We know that contact tracing happens too late or not at all. If we’re really serious about tackling the STD crisis, we need to get more people diagnosed.

Preliminary data for 2021 shows nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the U.S., according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been on the rise for a decade. In its most recent prevalence estimates, the agency says that on any given day, 1 in 5 Americans is infected with one of eight common STDs.

The push to make home testing for STDs as easy and common as home covid and pregnancy testing comes from a number of sectors. Public health officials say the overextended workforce cannot handle the dire need for testing and surveillance. Diagnostic and pharmaceutical companies see business opportunities in unmet demand.

The medical science that supports STD testing is neither new nor mysterious. Depending on the test, it may involve collecting a urine sample, a finger prick for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and public health clinics have been performing such tests for years.

The issue for regulators is whether the sampling kit can be safely adapted for home use. Unlike rapid antigen tests for covid, which produce results in 15 to 20 minutes, home STD kits on the market require patients to collect their own samples, then package and send them to a laboratory for analysis.

In the past three years, as the pandemic has caused clinics that provide low-cost care to drastically cut back on private services, a number of public health departments — including state agencies in Alabama, Alaska, and Maryland — have begun sending out free STD tests. tie to the citizens. Universities and nonprofits are also leading home-testing efforts.

And dozens of commercial companies are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of online laboratory tests, reported sales of its STD kit suite increased 120% in the first half of this year compared to the first half of 2021.

CVS Health began selling self-packaged STD kits in October, priced at $99.99. Unlike most home kits, the CVS version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies that are rapidly developing tests. And Cue Health, which sells covid tests, is poised to launch clinical trials for rapid home tests for chlamydia and gonorrhea that will set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly headed the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants the company to prove that the home collection kits are as accurate as those used in clinics, and that the samples did not spoil during shipping.

“The agency does not believe this test is being marketed legally at this time,” said Gutierrez, a partner at NDA Partners, a consulting firm that advises companies looking to bring health care products to market.

“CVS shouldn’t be selling those tests,” he added.

In response to KHN’s questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action in specific cases, the statement said.

CVS spokeswoman Mary Gattuso said the pharmacy chain follows the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy our customers,” Gattuso said.

Everly Health and other companies describe their kits as laboratory-developed tests, similar to diagnostics that some hospitals have developed for use at home. And they insist their tests can be marketed legally because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.

“The instruments and tests used by the laboratories we use are comparable to – and often the same as – those used by laboratories used by doctors’ offices,” said Dr. Liz Kwo, chief medical officer at Everly Health. “Our home sample collection methods, such as dried blood spots and saliva, have been widely used for many years.”

The home collection kit appealed to Uxmal Caldera, 27, of Miami Beach, Florida, who preferred testing in the privacy of her home. Caldera, who does not own a car, said the home test saves time and money to go to the clinic.

Caldera has been testing herself for HIV and other STDs every three months for more than a year, part of routine monitoring for people taking PrEP, a daily pill regimen to prevent HIV infection.

“Doing it yourself is not that difficult,” said Caldera, who is uninsured but receives free tests through a community foundation. “The instructions are very clear. I got results in maybe four days. For sure, I will recommend it to other people.”

Dr. Leandro Mena, director of the CDC’s Division of STD Prevention, said he would like to see home STD testing become as routine as home pregnancy testing. An estimated 16 million to 20 million tests for gonorrhea and chlamydia are performed in the U.S. each year, Mena said. Using at-home STD tests, he said, can double or triple that number.

He said doctors have years of experience using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed about 23,000 home STD kits since 2004, said Charlotte Gaydos, principal investigator with the center. The FDA generally allows such use if it is part of research supervised by medical professionals. The center’s tests are currently used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.

Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a lot of data showing that home testing works,” Gaydos said.

But Gaydos said the study was limited to a small sample size. He says he doesn’t have the multimillion-dollar funding needed to run the kind of comprehensive trials the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health laboratories are reluctant to handle home kits. “Public health labs won’t touch it without the FDA’s blessing,” Mahn said.

Public health clinics often provide STD testing at little or no cost, while health insurance usually covers private testing at private practices. But most customers pay out-of-pocket for direct-to-consumer kits. Commercial prices put them out of reach for many people, especially teenagers and young adults, who account for almost half of STDs.

Adalja, at Johns Hopkins, said the FDA has a history of moving slowly on home testing. The agency spent seven years evaluating the first approved at-home HIV test, which hit the market in 2012.

“Home testing is the way forward,” said Laura Lindberg, a professor of public health at Rutgers University. “The pandemic opened the door to testing and treatment at home without going to a healthcare provider, and we can’t put the genie back in the bottle.”

Liz Szabo: [email protected], @LizSzabo

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