And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS's version is available in stores.Cue Health
"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.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.
Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, Florida, who prefers to test in the privacy of his home. Caldera, who doesn't have a car, said home testing saves him the time and expense of getting to a clinic. Dr. Leandro Mena, director of the CDC's Division of STD Prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million to 20 million tests for gonorrhea and chlamydia are performed in the U.S. each year, Mena said. Widespread use of at-home STD testing, he said, could double or triple that number.Johns Hopkins Center