Companies are racing to put at-home STD testing on the market. But are they dependable?

Companies are racing to put at-home STD testing on the market. But are they dependable?

Among the most surprising legacies of the COVID-19 pandemic is the rapidity with which federal regulators, the health care sector, and consumers made at-home testing a reliable instrument for controlling a public health problem.

But same rapid attention is lacking from another, less recognized epidemic: the expansion of sexually transmitted diseases, which can cause chronic discomfort and infertility in infected adults as well as disability or death in infected newborns. This difference has prompted experts, public health groups, and health care corporations to urge the federal government to approve at-home testing kits, which may substantially increase the number of Americans who test for sexually transmitted diseases.

More than a dozen self-testing kits are already available for purchase online, ranging in price from $69 to $500 depending on the brand and types of illnesses they can detect.

With the exception of HIV tests, the FDA has not approved STD test kits for use outside of a medical environment. This makes consumers uncertain about their dependability, despite the significant increase in home use.

In contrast to COVID fast antigen tests, home STD kits need patients to collect their own samples and send them to a lab for examination. The concern for regulators is whether home-use kits can be adapted reliably. Eric Harkleroad/KHN

According to Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, the STD pandemic is “out of control.” “We are missing diagnosis, we know. We are aware that contact tracing is occurring either tardily or not at all. If we’re serious about addressing the STD epidemic, we must diagnose more patients.”

According to the Centers for Disease Control and Prevention, almost 2.5 million cases of chlamydia, gonorrhea, and syphilis were reported in the United States in 2021. Cases of syphilis and gonorrhea have increased during the past decade. According to the agency’s most recent prevalence estimate, 1 in 5 Americans are infected with one of eight prevalent STDs on any given day.

Multiple industries are pushing to make at-home STD testing as simple and widespread as at-home COVID and pregnancy testing. According to public health officials, their overworked employees are incapable of meeting the rising demand for testing and surveillance. Diagnostic and pharmaceutical businesses view the unmet demand as a business opportunity.

The medical science underlying STD testing is not novel nor obscure. It may require collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples, depending on the test. For decades, medical centers and community health clinics have conducted these tests.

The concern for regulators is whether home-use sampling kits can be adapted reliably. In contrast to quick antigen testing for COVID, which provide findings within 15 to 20 minutes, home STD kits need patients to collect their own samples and submit them to a lab for analysis.

In the past three years, as the pandemic has forced low-cost clinics to severely reduce in-person services, a number of public health authorities, including those in Alabama, Alaska, and Maryland, have begun mailing residents free STD test kits. Universities and charitable organizations are also leading the charge for at-home testing.

Moreover, scores of businesses are entering or expanding direct-to-consumer sales. Everly Health, a digital health startup that sells a range of lab tests online, revealed that their suite of STD kits experienced a 120% increase in sales during the first half of this year compared to the first half of 2021.

In October, CVS Health began selling its own packaged STD kit for $99.99. CVS’s version, unlike other home kits, is available in shops.

Hologic, Abbott, and Molecular Testing Laboratories are among the urgently developing test companies. And Cue Health, which sells COVID antigen tests, is preparing to conduct a clinical trial for a quick home test for chlamydia and gonorrhea that would set a new standard by providing results in just 20 minutes.

Alberto Gutierrez, a former leader of the FDA unit that regulates diagnostic testing, stated that agency officials have been concerned for years about the dependability of home tests. The FDA requires firms to demonstrate that home collection kits are just as accurate as those used in clinics and that samples do not degrade during shipment.

“At this time, the FDA does not believe that these tests can be legally marketed,” said Gutierrez, a partner at NDA Partners, a consulting business that assists companies looking to bring health care products to market.

He continued, “CVS should not market that test.”

In response to concerns from KHN, the FDA stated that it considered home collection kits, which may contain swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices requiring agency evaluation. The FDA “usually does not comment” on whether or whether it intends to take action in a particular case, according to the statement.

Mary Gattuso, a representative for CVS, stated that the pharmacy business complies with the law. Gattuso stated, “We are committed to assuring the safety, functionality, compliance with legislation, and customer satisfaction of our goods.”

Everly Health and other companies advertised their kits as laboratory-developed testing, similar to the in-house diagnostics that some hospitals produce. In addition, they argue that their tests can be lawfully sold since their laboratories have been certified by a separate organization, the Centers for Medicare & Medicaid Services.

Dr. Liz Kwo, chief medical officer at Everly Health, stated that the tools and assays utilized by Everly Health’s laboratories are equivalent to, and frequently the same as, those used by physician’s offices. Our methods for collecting samples at home, such as dried blood spots and saliva, have been routinely utilized for decades.

Uxmal Caldera, 27, of Miami Beach, Florida, prefers to test in the privacy of his home, therefore home collection kits appeal to him. Caldera, who does not own a vehicle, stated that home testing saves him the time and money required to travel to a clinic.

Caldera has been testing himself for HIV and other sexually transmitted diseases (STDs) every three months for over a year, as part of standard monitoring for persons taking PrEP, a daily tablet regimen to prevent HIV infection.

Caldera, who is uninsured but obtains free tests via a community foundation, stated, “It’s not difficult at all to do it on your own.” “The instructions are really straightforward. I receive the findings in roughly four days. Definitely, I would recommend it to others.”

Dr. Leandro Mena, head of the CDC’s Division of STD Prevention, wants at-home STD testing to become as commonplace as at-home pregnancy testing. Mena estimated that between 16 and 20 million gonorrhea and chlamydia tests are conducted annually in the United States. According to him, widespread usage of at-home STD testing might double or triple that amount.

He highlighted that doctors had used home collecting kits for years.

Since 2004, the Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has delivered over 23,000 home STD testing kits, according to Charlotte Gaydos, the center’s chief investigator. The FDA normally permits such usage if it is part of medically supervised research. The Alaskan health department and Native American tribes in Arizona and Oklahoma now employ the center’s exams.

Gaydos has published scores of studies demonstrating the accuracy and simplicity of home collection kits for illnesses such as chlamydia and gonorrhea.

“A vast quantity of evidence indicates that home testing is effective,” said Gaydos.

However, Gaydos highlighted that her research was restricted by small sample numbers. She stated that she lacks the millions of dollars necessary to do the type of extensive trial that the FDA generally wants for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, stated that many public health laboratories are unwilling to process home kits. Mahn stated, “The public health labs will not touch it without FDA approval.”

Public health clinics frequently offer STD testing at low or no cost, but private practice testing is typically covered by health insurance. However, the majority of buyers pay cash for direct-to-consumer kits. Many people, especially teens and young adults, who account for about half of all STDs, cannot afford them due to their high cost.

According to Adalja of Johns Hopkins, the FDA has a history of moving slowly with regard to home testing. The agency spent seven years evaluating the first home HIV test it authorized, which debuted in 2012, before approving it.

Laura Lindberg, a professor of public health at Rutgers University, stated, “Home testing is the way of the future.” We won’t be able to put the genie back in the bottle because the pandemic opened the door to testing and treatment at home without traveling to a health care practitioner.

KHN (Kaiser Health News) is a national news organization that delivers in-depth health-related journalism. KHN, with Policy Analysis and Polling, is one of KFF’s three primary running programs (Kaiser Family Foundation). KFF is an endowed nonprofit organization that provides information on national health issues.


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