Health
First at-home HPV test approved by FDA, could replace Pap smear
The Food and Drug Administration (FDA) has approved the first at-home screening test for cervical cancer, the product’s maker announced on Friday.
The DIY test could serve as an alternative to in-person “Pap smears,” which are recommended every three years for women up to age 65.
The self-collection device — the Teal Wand, made by Teal Health in San Francisco — allows women to procure a sample and mail it in for laboratory analysis.
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The test is designed to detect human papillomavirus (HPV), the virus that causes almost all cervical cancer cases.
The Food and Drug Administration has approved the first at-home screening test for cervical cancer, the product’s maker announced on Friday. (iStock)
The approval comes after a clinical trial including more than 600 women, in which the Teal Wand had a 96% accuracy rate of detecting cervical precancers.
In the study, 86% of participants said they’d be more likely to comply with cervical cancer screening recommendations if they could do it at home, Teal Health reported.
Additionally, 94% said they would prefer to self-collect at home as long as the results were accurate.
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“Cervical cancer is largely preventable, yet screening rates in the U.S. continue to lag, and the FDA approval of this at-home Teal Wand self-collection device is a critical step forward,” said Dr. Christine Conageski, associate professor, OB-GYN and director of the Complex Dysplasia Clinic at the University of Colorado, who was a principal investigator in the SELF-CERV trial.
“It offers an evidence-based way to expand access without compromising accuracy,” she added in a statement.
“Cervical cancer is largely preventable, yet screening rates in the U.S. continue to lag, and the FDA approval of this at-home Teal Wand self-collection device is a critical step forward,” a doctor said. (iStock)
Approximately 11,500 new cervical cancer diagnoses are made in the U.S. each year, and the disease causes 4,000 annual deaths, according to the Centers for Disease Control and Prevention.
In addition to the cervical cancer risk, some higher-risk incidences of HPV can also cause other types of cancers, according to experts.
“Any type of test that helps detect cervical cancer is a win.”
Women between the ages of 25 and 65 who are at average risk of cervical cancer will soon be able to order the at-home test at www.getteal.com, according to the company’s announcement.
Kits are expected to first become available in California starting in June, with plans to expand across the country “as soon as possible,” the company said in its announcement.
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“Teal is working with major insurance providers and plans to have flexible payment options, helping to remove financial concerns and ensuring more women have access to this preferred at-home screening if they want it,” the company stated.
Approximately 11,500 new cervical cancer diagnoses are made in the U.S. each year, and the disease causes 4,000 annual deaths. (iStock)
In addition to the collection kit, the product also includes a telehealth service with support from medical providers throughout the process.
Women who test positive for HPV will be referred for a traditional Pap smear. Those who do not test positive are not considered at risk of cervical cancer and will not need to screen again for three to five years.
“Some women are scared of a traditional Pap smear or find the process uncomfortable — as a result, they put off this vital test,” said Ami Vaidya M.D., co-chief of gynecologic oncology at Hackensack University Medical Center’s John Theurer Cancer Center, in a press release. (She was not involved in the trial.)
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“This could be an important tool in getting more women regularly screened, especially those who don’t have access to a medical provider. Any type of test that helps detect cervical cancer is a win.”
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A new report by the American Heart Association (AHA) included some troubling predictions for the future of women’s health.
The forecast, published in the journal Circulation on Wednesday, projected increases in various comorbidities in American females by 2050.
More than 59% of women were predicted to have high blood pressure, up from less than 49% currently.
The review also projected that more than 25% of women will have diabetes, compared to about 15% today, and more than 61% will have obesity, compared to 44% currently.
As a result of these risk factors, the prevalence of cardiovascular disease and stroke is expected to rise to 14.4% from 10.7%.
The prevalence of cardiovascular disease and stroke in women is expected to rise to 14.4% from 10.7% by 2050. (iStock)
Not all trends were negative, as unhealthy cholesterol prevalence is expected to drop to about 22% from more than 42% today, the report stated.
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Dr. Elizabeth Klodas, a cardiologist and founder of Step One Foods in Minnesota, commented on these “jarring findings.”
“The fact that on our current trajectory, cardiometabolic disease is projected to explode in women within one generation should be a huge wake-up call,” she told Fox News Digital.
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“Hypertension, diabetes, obesity — these are all major risk factors for heart disease, and we are already seeing what those risks are driving. Heart disease is the No. 1 killer of women, eclipsing all other causes of death, including breast cancer.”
Cardiovascular disease is the leading cause of death for women in the U.S. and around the world. (iStock)
Klodas warned that heart disease starts early, progresses “stealthily,” and can present “out of the blue in devastating ways.”
The AHA published another study on Thursday revealing one million hospitalizations, showing that heart attack deaths are climbing among adults below the age of 55.
The more alarming finding, according to Klodas, is that young women were found more likely to die after their first heart attack than men of the same age.
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“This is all especially tragic since heart disease is almost entirely preventable,” she said. “The earlier you start, the better.”
Children can show early evidence of plaque deposition in their arteries, which can be reversed through lifestyle changes if “undertaken early enough and aggressively enough,” according to the expert.
Moving more is one part of protecting a healthy heart, according to experts. (iStock)
Klodas suggested that rising heart conditions are associated with traditional risk factors, like smoking, high blood pressure, high cholesterol, diabetes, obesity and a sedentary lifestyle.
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Doctors are also seeing higher rates of preeclampsia, or high blood pressure during pregnancy, as well as gestational diabetes. Klodas noted that these are sex-specific risk factors that don’t typically contribute to complications until after menopause.
The best way to protect a healthy heart is to “do the basics,” Klodas recommended, including the following lifestyle habits.
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Klodas especially emphasized making improvements to diet, as the food people eat affects “every single risk factor that the AHA’s report highlights.”
“High blood pressure, high blood sugar, high cholesterol, excess weight – these are all conditions that are driven in part or in whole by food,” she said. “We eat multiple times every single day, which means what we eat has profound cumulative effects over time.”
“Even a small improvement in dietary intake, when maintained, can have a massive positive impact on health,” a doctor said. (iStock)
“Even a small improvement in dietary intake, when maintained, can have a massive positive impact on health.”
The doctor also recommends changing out a few snacks per day for healthier choices, which has been proven to “yield medication-level cholesterol reductions” in a month.
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“Keep up that small change and, over the course of a year, you could also lose 20 pounds and reduce your sodium intake enough to avoid blood pressure-lowering medications,” Klodas added.
“Women should not view the AHA report as inevitable. We have power over our health destinies. We just need to use it.”
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Nearsightedness (myopia) is skyrocketing globally, with nearly half of the world’s population expected to be myopic by 2050, according to the World Health Organization.
Heavy use of smartphones and other devices is associated with an 80% higher risk of myopia when combined with excessive computer use, but a new study suggests that dim indoor lighting could also be a factor.
For years, scientists have been puzzled by the different ways myopia is triggered. In lab settings, it can be induced by blurring vision or using different lenses. Conversely, it can be slowed by something as simple as spending time outdoors, research suggests.
Nearsightedness occurs when the eyeball grows too long from front to back, according to the American Optometric Association (AOA). This physical elongation causes light to focus in front of the retina rather than directly on it, making distant objects appear blurry.
The study suggests that myopia isn’t caused by the digital devices themselves, but by the low-light environments where they are typically used. (iStock)
Researchers at the State University of New York (SUNY) College of Optometry identified a potential specific trigger for this growth. When someone looks at a phone or a book up close, the pupil naturally constricts.
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“In bright outdoor light, the pupil constricts to protect the eye while still allowing ample light to reach the retina,” Urusha Maharjan, a SUNY Optometry doctoral student who conducted the study, said in a press release.
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“When people focus on close objects indoors, such as phones, tablets or books, the pupil can also constrict — not because of brightness, but to sharpen the image,” she went on. “In dim lighting, this combination may significantly reduce retinal illumination.”
High-intensity natural light prevents myopia because it provides enough retinal stimulation to override the “stop growing” signal, even when pupils are constricted. (iStock)
The hypothesis suggests that when the retina is deprived of light during extended close-up work, it sends a signal for the eye to grow.
In a dim environment, the narrowed pupil allows so little light through that the retinal activity isn’t strong enough to signal the eye to stop growing, the researchers found.
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In contrast, being outdoors provides light levels much brighter than indoors. This ensures that even when the pupil narrows to focus on a nearby object, the retina still receives a strong signal, maintaining healthy eye development.
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The team noted some limitations of the study, including the small subject group and the inability to directly measure internal lens changes, as the bright backgrounds used to mimic the outdoors made pupils too small for standard equipment.
Researchers believe that increasing indoor brightness during close-up work could be a simple, testable way to slow the global nearsightedness epidemic. (iStock)
“This is not a final answer,” Jose-Manuel Alonso, MD, PhD, SUNY distinguished professor and senior author of the study, said in the release.
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“But the study offers a testable hypothesis that reframes how visual habits, lighting and eye focusing interact.”
The study was published in the journal Cell Reports.
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