The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.ĬVS spokesperson Mary Gattuso said the pharmacy chain is following the law. In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. “CVS should not be selling that test,” he added. “The agency doesn’t believe these tests are legally marketed at this point,” said Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping. And Cue Health, which sells covid tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.Īlberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. Unlike most home kits, CVS’ version is available in stores. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.ĬVS Health began selling its own bundled STD kit in October, priced at $99.99. Universities and nonprofits are also spearheading at-home testing efforts.Īnd dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. In the past three years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments - among them state agencies in Alabama, Alaska, and Maryland - have started mailing free STD test kits to residents. Unlike rapid antigen tests for covid, which produce results in 15 to 20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis. The issue for regulators is whether sampling kits can be reliably adapted for in-home use. The issue for regulators is whether kits can be reliably adapted for in-home use. Unlike rapid antigen tests for covid, the home STD kits on the market require patients to collect their own samples, and then mail them to a lab for analysis. Medical centers and community health clinics have performed such testing for decades. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. The medical science underpinning STD testing is not particularly new or mysterious. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. The push to make at-home testing for STDs as easy and commonplace as at-home covid and pregnancy testing is coming from several sectors. In its most recent prevalence estimate, the agency said that on any given day, 1 in 5 Americans are infected with any of eight common STDs. Reported cases of syphilis and gonorrhea have been climbing for about a decade. Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the U.S., according to the Centers for Disease Control and Prevention. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.” We know that contact tracing is happening late or not at all. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security. The STD epidemic is “out of control,” said Dr.
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