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US approves first at-home cervical cancer screening device
US approves first at-home cervical cancer screening device

Sinar Daily

time17-05-2025

  • Health
  • Sinar Daily

US approves first at-home cervical cancer screening device

Users request a kit online, have a brief visit with a telehealth provider to gauge eligibility and then the kit is prescribed. They then collect the sample and ship it to a lab for analysis. 17 May 2025 05:00pm This undated handout image obtained on May 9, 2025, courtesy of Teal Health, shows the Teal Wand, an at-home cervical cancer screening device approved by the FDA. (Photo by Nicole Morrison/Teal Health/AFP) WASHINGTON - The US Food and Drug Administration has approved an at-home cervical cancer screening tool as an alternative to Pap smears by a gynecologist, the company behind the device said recently. The "Teal Wand" -- a self-collection vaginal swab shaped like a tampon and developed by Teal Health -- will be available online for individuals aged 25 to 65 who are at average risk for cervical cancer. Users request a kit online, have a brief visit with a telehealth provider to gauge eligibility and then the kit is prescribed. They then collect the sample and ship it to a lab for analysis. Cervical cancer, which affects the lower part of the uterus, is diagnosed in about 0.6 percent of women. Although HPV vaccination and regular screening are highly effective at preventing the disease, more than one in four women fall behind on routine appointments. "When we make care easier to get, we help women stay healthy, for themselves and for the people who rely on them every day," Teal Health CEO Kara Egan said in a statement. The Teal Wand tests for high-risk strains of human papillomavirus (HPV), the primary cause of cervical cancer. A large clinical trial found its accuracy comparable to a traditional Pap smear, which requires a speculum and is often cited as a barrier to screening due to discomfort. Most sexually active people will contract HPV at some point, though only a small fraction develop cancer. Teal Health did not disclose pricing but said it is in talks with insurers to ensure affordability. The product will launch first in California in June. - AFP More Like This

Why Selena Gomez Is Not A Billionaire. Plus: Stop Overthinking
Why Selena Gomez Is Not A Billionaire. Plus: Stop Overthinking

Forbes

time16-05-2025

  • Business
  • Forbes

Why Selena Gomez Is Not A Billionaire. Plus: Stop Overthinking

This is this week's ForbesWomen newsletter, which every Thursday brings news about the world's top female entrepreneurs, leaders and investors straight to your inbox. Click here to get on the newsletter list! Late last week, the FDA granted approval to something that could change the paradigm for cervical cancer screening in the U.S.: It greenlit the Teal Wand, an at-home HPV screening device from Teal Health. Following the announcement, I spoke with Kara Egan, the cofounder and CEO of Teal Health, about what exactly this means for how women get screened for cervical cancer—and when her device will be available commercially. 'The clinical study results show we have the same accuracy as the doctor-collected samples,' Egan explained. Plus, she said, '94% of women in our clinical trial said they prefer this to the standard of care.' (AKA, the invasive and often painful pap smear.) Egan said that she and her team at Teal are getting ready to launch commercially in June, starting in California, and she hopes other states quickly follow. Gallup data shows that some 72 million women have skipped or delayed a preventative healthcare test, and Egan's own research through Teal had similar findings. 'While there are definitely populations that are less likely to be screened—uninsured are near 40% less likely to be on top of their screenings—what we found was it was near-universal: One in four women are behind on their screenings.' Egan and I also talked a bit about the entrepreneurial inspiration behind Teal, and how her background in healthcare investing helped her build the company with her cofounder. You can check out the full conversation here! Cheers! Maggie BEVERLY HILLS, CA - MARCH 2: Selena Gomez attends the 2025 Vanity Fair Oscar After Party Arrivals ... More on March 3, 2025 at Wallis Annenberg Center for the Performing Arts in Beverly Hills, California. (Photo by Robert Smith/Patrick McMullan via Getty Images) In September 2024, Bloomberg reported Selena Gomez' net worth to be $1.3 billion thanks to her makeup line, Rare Beauty, which was founded in 2019 and launched in 2020. Multiple media outlets have since called the 32-year-old Gomez a billionaire as well. Based on Forbes' reporting, Gomez is very wealthy, but estimated to be worth roughly $700 million. This figure still ranks the former Disney Star among the wealthiest self-made female entrepreneurs in the country—and one of the richest celebrities—but the breakdown of her fortune helps explain why she may be somewhat limited in how much money she can or is willing to sink into Wondermind, the mental health startup that in recent weeks has missed payroll and laid off two-thirds of its staff. American tennis player Coco Gauff during the Italian Open of tennis at Foro Italico. Rome (Italy), ... More May 14th, 2025 (Photo by Massimo Insabato/Archivio Massimo Insabato/Mondadori Portfolio via Getty Images) Forbes released its annual list of the world's highest paid athletes on Thursday, and for the second consecutive year, no woman lands among the world's top 50. Serena Williams was the last to do it, in 2023—her sixth appearance on the list in nine years—but she has settled into retirement and is no longer eligible. Here's why not even Coco Gauff made this year's final cut. Touchland, a buzzy hand sanitizer and body spray brand founded by Andrea Lisbona and launched in 2018, announced Monday that it has been acquired for up to $880 million by personal care conglomerate Church & Dwight. The deal includes $700 million at closing and another $180 million contingent on Touchland's 2025 net sales. (Trailing twelve month sales as of March 31 hit $130 million, the company says.) 'Everything would be better if we blew open the model of what good leadership looks like,' says founder and executive Amanda Litman, whose new book, When We're in Charge: The Next Generation's Guide to Leadership, came out this week. Litman spoke to ForbesWomen contributor Marianne Schnall about the book's launch and how the next generation of leaders can transform outdated leadership models and workplace cultures to lead in new ways. A last-minute proposal on the sale of public land from House Republicans during budget negotiations could have negative ramifications for the communities nearest the parcels that could be privatized, says Jennifer Novak, an environmental lawyer. Novak spoke to ForbesWomen editor Maggie McGrath on "Forbes Newsroom" about the proposal and what it could mean for communities near public land in the long term. 1. Break free from over-thinking. Opportunities to overthink are endless. The good news is that there are some strategies we can all use to break the cycle of over-thinking. One that sounds particularly intriguing? Schedule your 'worry time.' 2. Own the power of your own brand. Melissa Ben-Ishay, cofounder and CEO of cupcake chain Baked by Melissa, didn't initially want to be the CEO of her own company. She spoke to ForbesWomen editor Maggie McGrath about how she tapped into her inner confidence and built the skills she needed to become not just founder and creative, but chief executive. 3. Make friends in your 40s. Some 53% of American adults report having between one and four close friends, and 8% say they have no close friends. If you want to build a stronger inner circle, here are some proven strategies that work. More than a decade of air traffic control staffing issues have been coming to a head recently, particularly at Newark Liberty International Airport where hundreds of flights were disrupted following multiple communications outages between air traffic control and pilots. Which major U.S. airport also reported communications issues this week? Check your answer.

First at-home test to screen for cervical cancer approved by FDA
First at-home test to screen for cervical cancer approved by FDA

Miami Herald

time13-05-2025

  • Health
  • Miami Herald

First at-home test to screen for cervical cancer approved by FDA

The U.S. Food and Drug Administration on Friday approved Teal Health to provide the nation's first at-home test kit to screen for cervical cancer. The Teal Wand, which will be available for those age 25 to 65 at average risk, tests for human papillomavirus, or HPV, a virus that causes most cervical cancers. Teal Health CEO Kara Egan didn't say how much the test would cost. Egan anticipates the test will be covered by insurance. They will first be available in California in June and then expand nationwide. Until now, the only way to screen for cervical cancer was in a doctor's office during a pelvic exam. 'As a mom and a woman, I get how easy it is to put your own health last,' Egan said in a news release. 'That's why this FDA approval means so much; it's not just about an innovative new product, it's about finally giving women an option that actually makes sense for their lives -- something that can be done quickly and comfortably at home. Because when we make care easier to get, we help women stay healthy, for themselves and for the people who rely on them every day.' Because of the invasive aspect, the company found 1 in 4 women in the United States are behind in testing. Dr. Emeline Aviki, a gynecologic-oncologist at New York University Langone Health, who worked on initial studies, told CNBC: 'It's not a fun exam and it's the easiest thing to cancel.' She worked on early studies to validate the new test. In a Teal Health study, 86% of participants thought they would more likely stay up-to-date with cervical cancer screening if they could do it at home. And 94% said they would prefer to self-collect at home if it were accurate. In the new vaginal swab, a speculum is used and samples of cells are collected from the cervix. Last year, the FDA approved a similar swab, also performed by patients themselves, that's collected in a doctor's office. 'What's different about this new indication is that this sample can be collected at home and not in a medical setting,' Dr. George Sawaya, a gynecologist at University of California San Francisco Health, told CNBC. You have to logically believe that would increase access if people's main barrier was getting to a medical setting.' Patients can order the test kit after a telehealth appointment with a doctor. The swab is then mailed to a lab for analysis. The product initially must be prescribed by one of Teal Health's virtual providers. If there is a positive test, women may need additional tests in a doctor's office. The American Cancer Society estimates that 13,360 women will be diagnosed with cervical cancer this year and about 4,320 women will die. 'Cervical cancer incidence rates decreased by more than half from the mid-1970s to the mid-2000s because of widespread screening uptake,' ACA said. Cervical cancer mortality rates also dropped by more than half since the mid-1970s. The study found the test detects cervical precancer 96% of the time. 'As a Principal Investigator in the SELF-CERV trial, I saw firsthand how receptive and excited women were to use the Teal Wand,' Dr. Christine Conageski, associate professor, OB-GYN and director of the Complex Dysplasia Clinic at the University of Colorado, said in the company's news release. '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. It offers an evidence-based way to expand access without compromising accuracy.' She noted women must do more than be tested. 'But access is only part of the solution,' she said. 'Comprehensive screening must go hand in hand with structured, reliable follow-up.' Last year, researchers found a new urine test might help doctors more easily screen for cervical cancer. The test looks for proteins generated by a type of cancer-causing human papillomavirus, HPV 16. Copyright 2025 UPI News Corporation. All Rights Reserved.

Teal Health gains FDA approval for cervical cancer screening device
Teal Health gains FDA approval for cervical cancer screening device

Yahoo

time12-05-2025

  • Health
  • Yahoo

Teal Health gains FDA approval for cervical cancer screening device

The US Food and Drug Administration (FDA) has secured approval to Teal Health's at-home vaginal sample self-collection device, Teal Wand, for cervical cancer screening. This prescription device claims to be the first and only product of its kind in the US, and will soon be available on the company's website for those aged 25–65 at average risk of cervical cancer. It includes a collection kit and a telehealth service, offering virtual access to medical providers of the company who prescribe the kit, review laboratory results, and offer support throughout the screening process. The device claims to enable women to self-test for HPV (human papillomavirus), the primary cause of cervical cancer, using Roche's cobas HPV test, recommended by medical guidelines. According to the company, women can send the self-collected sample to a certified laboratory for processing, offering the same accuracy as tests conducted in a clinical setting. The FDA approval was based on the company's SELF-CERV study, which confirmed that the Teal Wand's self-collected samples match the performance of clinician-collected samples. The study, reflecting the diversity of the US population, claims to have shown a 96% detection rate for cervical precancer. It also revealed a significant preference for at-home screening, with 86% of subjects more likely to stay current with their screenings if an at-home option were available, and 94% preferring the Teal Wand. With this approval, the company is preparing to make the Teal Wand available as of next month, initially in California, with plans for a rapid countrywide expansion. The company noted that it is collaborating with insurance providers and is planning to offer payment alternatives to make the device accessible and affordable. Teal Health CEO and co-founder Kara Egan said: 'As a mother and a woman, I get how easy it is to put your own health last. That's why this FDA approval means so much; it's not just about an innovative new product, it's about finally giving women an option that makes sense for their lives – something that can be done quickly and comfortably at home.' "Teal Health gains FDA approval for cervical cancer screening device" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

This company wants to replace your Pap smear — and promises its DIY cancer screening is less painful
This company wants to replace your Pap smear — and promises its DIY cancer screening is less painful

New York Post

time12-05-2025

  • Health
  • New York Post

This company wants to replace your Pap smear — and promises its DIY cancer screening is less painful

Short of shopping for a bikini after the holidays, getting a Pap smear has to be one of the most dreaded parts of a woman's life. Now, a new device — which was recently approved by the FDA — promises to be the first at-home test for cervical cancer screening. And, according to Teal Health co-founder and CEO Kara Egan, the Teal Wand will revolutionize the way women approach pelvic exams. 4 The Teal Wand promises to be the first at-home test for cervical cancer screening. Teal Health 'Generally, no one enjoys going to the OBGYN for a routine pap smear,' Egan told The Post. 'Between the uncomfortable stirrups, the paper gown, and the cold, metal speculum, it's usually an unpleasant experience many women avoid. 'In fact, 1 in 4 women aren't regularly screened due to access issues or discomfort with traditional exams. With this in mind, we set out to change the experience entirely, and offer a comfortable at-home option to test for cervical cancer.' Egan also noted that Pap smears aren't even 'the recommended way of screening' anymore, with modern medicine preferring the HPV test 'because of its sensitivity and accuracy.' The Teal Wand looks a bit like a tampon applicator, with a soft sponge tip that collects cervical cells for HPV testing. To use it, women request a kit online, get approved by a Teal Health provider and receive the device in the mail. 4 Egan also noted that pap smears aren't even 'the recommended way of screening' anymore, with modern medicine preferring the HPV test 'because of its sensitivity and accuracy.' Iryna – After a quick self-collection at home — Egan said 92% of users finished in under five minutes — the sample is sealed and sent to a CLIA-certified lab for analysis. Results are then reviewed by certified doctors and users can connect with Teal's virtual care team to discuss any next steps. Each year in the US, about 11,500 new cases of cervical cancer are diagnosed and about 4,000 women die from it, according to the CDC. Cervical cancer is one of the most preventable cancers — if it's caught early through regular screening. But so many women put off or skin their Paps altogether, dreading their recommended annual gynecological exam — and the at times painful scraping of the small brush used to collect the sample from the cervic. 4 To use the Teal Wand, women request a kit online, get approved by a Teal Health provider, and receive the device in the mail. Teal Health 'Pain and discomfort with the in-office speculum exam are some of the top reasons women are behind on their screening,' Egan said. 'Other reasons include anything from living in OBGYN care deserts, to medical anxiety or sexual trauma, to not having enough time to prioritize their health over their family priorities.' With the Teal Wand, they are hoping to put the power back into women's hands — literally. 'That's why we created the Teal Wand — to give women the option to screen comfortably from home at their convenience,' she said. The wand is single-use and Egan noted that it 'will be covered by insurance, with out-of-pocket and HSA/FSA payment options to ensure it is affordable and accessible for all women.' 4 Women collect samples at home and send them to a certified lab for testing. Teal Health/AFP via Getty Images And when it comes to effectiveness — the numbers are solid, according to Egan. 'In a clinical trial, it found that Teal Wand's clinical sensitivity is 96%, matching the performance of clinician-collected samples,' she said. 'Self-collected samples had an agreement of 95% with clinician-collected samples, surpassing the threshold for equivalency.' Women seem to get the hang of it quickly as well — 99% reported no difficulty using the device and 98% of samples were valid for lab analysis. The new device was just approved by the FDA on Friday. Their decision was based on a study of more than 600 women, which found that their at-home samples performed as well as ones collected by doctors. While the price of the new wand hasn't been disclosed, the company said it is working with insurance providers for coverage and flexible payment options. They expect to begin selling test to people age 25 to 65 in June.

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