Latest news with #selfcollection
Medscape
20-05-2025
- Health
- Medscape
Home Self-Collection Equals Clinic Exam for HPV Screening
A self-collection (SC) device that could easily be used at home proved safe and accurate for cervical screening in the SELF-CERV prospective nonrandomized clinical trial, as reported in JAMA Network Open . Known as the Teal Wand, the device was recently approved by the US Food and Drug Administration (FDA) for home use. When compared with clinician-collected (CC) samples, SC specimens showed high positive agreement for detecting high-risk human papillomavirus (hrHPV) as well as equivalent sensitivity for cervical dysplasia. The patient-friendly device proved safe and easy to use. Christine Conageski, MD, MSc An at-home collection option is crucial to address clinic-related barriers to screening, according to Christine Conageski, MD, MSc, an associate professor of obstetrics and gynecology at University of Colorado Anschutz Medical Campus in Aurora, Colorado, and colleagues. She noted that 13,000 new cases of cervical cancer — a preventable disease — are still being diagnosed annually in the United States, with rates rising especially in rural counties. 'In essence, cervical cancer in the US has become a disease of access: Access to vaccination, screening, and timely treatment,' Conageski told Medscape Medical News . 'We saw an urgent need to address this gap. Our study was driven by the hope that at-home screening could help remove long-standing barriers and bring screening directly to the people who need it most.' Of key significance is the FDA's approval of the device for in-home use. 'That distinction is critical — it moves screening beyond the clinic and into patients' hands, which is where we believe the next major gains in cervical cancer prevention will happen,' she said. SELF-CERV Study The trial used a comparison design that clinically validated the SC device to provide vaginal specimens for cervical screening in a diverse US population. It tested a dry swab device, a single-patient use, disposable unit consisting of biocompatible, medical-grade injection-molded polymer components about the diameter of a standard tampon. The wand is designed to be inserted into the vagina with one hand. The trial included 599 individuals with paired SC and CC samples. The participants (age, 25-65 years; 57.8% White; 97.3% identifying as female) were recruited from 16 clinical sites, including both community and academic practices, from November 2023 to April 2024. Data were analyzed in 2024 from April to August. Eligible participants collected a sample with the SC method, followed by a standard CC sampling. Participants were followed up for safety and completed usability and screening preference surveys. Primary outcome measures were positive percentage agreement (PPA) and negative percentage agreement for the detection of hrHPV between the two sets of samples. Other study measures included clinical sensitivity for high-grade cervical dysplasia and usability. Among the 582 evaluable paired samples, the PPA between SC and CC samples for the detection of hrHPV was 95.2% (95% CI, 92.1%-97.1%; n = 278 of 292), exceeding the PPA endpoint for cervical screening. The absolute clinical sensitivity for the detection of high-grade cervical dysplasia was 95.8% (95% CI, 86.0%-98.8%; n = 46 of 48), equivalent to the CC sensitivity (relative sensitivity, 1.00). More than 90% of participants said the device instructions were easy or very easy to understand and would choose SC if they knew the results were comparable with CC results. Real-World Impact of At-Home Screening The significance of a comfortable home-based alternative to the intrusive speculum exam is clear. According to recent research by Diane M. Harper, MD, MPH, MS, a professor in the Departments of Family Medicine and Obstetrics & Gynecology at the University of Michigan in Ann Arbor, Michigan, 'the speculum is a major source of trauma and invasion that women will not tolerate.' Diane M. Harper, MD, MPH, MS In her research, women described the speculum exam with words such as 'awful, miserable, embarrassing, dreadful, excruciatingly painful, humiliating, exposing, and scary.' SC, in contrast, was characterized as 'comfortable, private, discreet, simple, convenient, worlds better, and innovative.' Self-sampling is also easier for women with vulvodynia, dyspareunia, vaginal atrophy, or urinary leakage, Harper added. Moreover, patients don't have to worry about clinic visits, transportation, time off work, and arranging care for children or elders at home. 'A host of inconveniences and barriers to the in-office exam are excluded by having an at-home option,' Harper said. One potential downside to home screening, however, is that a sampling device could break off in situ preventing removal. 'If it's not painful, then the patient can wait for an appointment to have the device removed. If it is painful, then she must go to urgent or emergency care to have it removed,' Harper said. She pointed out that private insurance carriers currently cover only 73% of their populations with appropriate cervical cancer screening, and those in federally sponsored care have 50% screening rates year over year. 'That means 30%-50% of US women are not being screened.' The successful Cologuard home screening option for colon cancer may provide a workable model. Harper recommends a health-system approach to incorporating self-sampling into the cervical cancer screening of all screen-eligible people. According to Conageski, the success of at-home screening will depend on thoughtful systems that support patients through the entire process — from test delivery to diagnosis and treatment. 'Simply sending someone an at-home test doesn't guarantee they'll complete it, return the sample, or have timely access to follow-up care if the result is positive,' she said. 'Community-based research and implementation science will be essential in building equitable, scalable models that ensure all individuals not only get screened but also receive the follow-up care they need.' In her view, the next research phase needs to focus on real-world implementation. 'Teal's digital platform offers a unique opportunity to study how at-home screening performs outside of controlled settings — delivering timely results directly to patients and tracking what happens next.' This study was supported by Teal Health, the National Institutes of Health, and Planned Parenthood.
The Independent
09-05-2025
- Health
- The Independent
First at-home test kit for cervical cancer approved by the FDA, company says
U.S. regulators have approved the first cervical cancer testing kit that allows women to collect their own sample at home before shipping it to a laboratory, according to a medical device company. Teal Health said Friday the Food and Drug Administration approved its Teal Wand for home use, offering a new way to collect vaginal samples that can detect the HPV virus that causes cervical cancer. Currently, HPV tests and pap smears are performed at a health clinic or doctor's office. An influential federal panel recommended last year the use of self-collection of HPV samples to boost screening. The FDA also recently expanded the use of two older HPV tests for self-collection, but those must be done at a medical office or mobile clinic. HPV, or human papillomavirus, is very common and is spread through sex. Most HPV infections clear up on their own, but persistent infection can lead to cancer of the cervix. Most cervical cancers occur in women who are inadequately screened, diagnosed or treated. To collect a sample, a swab or brush is inserted into the vagina and rotated, then the swab is put into a tube or container and processed at a lab. Teal Health's kit requires a prescription, which customers can obtain through one of the company's online health providers. The San Francisco-based company said it will initially beginning selling the kits in California next month before expanding to other states. The company also said it is working with insurers on health coverage for the test. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Associated Press
09-05-2025
- Health
- Associated Press
First at-home test kit for cervical cancer approved by the FDA, company says
WASHINGTON (AP) — U.S. regulators have approved the first cervical cancer testing kit that allows women to collect their own sample at home before shipping it to a laboratory, according to a medical device company. Teal Health said Friday the Food and Drug Administration approved its Teal Wand for home use, offering a new way to collect vaginal samples that can detect the HPV virus that causes cervical cancer. Currently, HPV tests and pap smears are performed at a health clinic or doctor's office. An influential federal panel recommended last year the use of self-collection of HPV samples to boost screening. The FDA also recently expanded the use of two older HPV tests for self-collection, but those must be done at a medical office or mobile clinic. HPV, or human papillomavirus, is very common and is spread through sex. Most HPV infections clear up on their own, but persistent infection can lead to cancer of the cervix. Most cervical cancers occur in women who are inadequately screened, diagnosed or treated. To collect a sample, a swab or brush is inserted into the vagina and rotated, then the swab is put into a tube or container and processed at a lab. Teal Health's kit requires a prescription, which customers can obtain through one of the company's online health providers. The San Francisco-based company said it will initially beginning selling the kits in California next month before expanding to other states. The company also said it is working with insurers on health coverage for the test. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
CNN
09-05-2025
- Health
- CNN
FDA approves first cervical cancer screening device that can be used at home, company says
Cancer Women's health New in medicineFacebookTweetLink Follow To get screened for cervical cancer, patients in the United States may no longer need to put their feet in those awkward stirrups, brace for the uncomfortable speculum or even take the time off from work for an in-person doctor's appointment. Soon, they will have the option to collect their own vaginal samples for screening from home – instead of a health care provider doing it for them. The US Food and Drug Administration has approved the first at-home self-collection device for cervical cancer screening in the United States, called the Teal Wand, according to the women's health company Teal Health. Last year, the FDA gave the company's Teal Wand 'breakthrough device' status, allowing the agency to review it on a faster timeline. Teal Wand, which will be provided in Teal Health's at-home self-collection kit, will require a prescription. Self-collected samples using the Wand are then mailed to a lab to be tested for HPV, the company announced Friday. Most cervical cancers are caused by human papillomavirus or HPV, and screening for HPV can help identify women who may be at risk of developing cervical cancer. Typically, when screening for cervical cancer, gynecologists collect samples for HPV testing, cervical cytology or both. Cervical cytology, also known as a Pap test or Pap smear, involves examining cervical cells for changes to detect precancerous or cancerous cells. The HPV test checks cells for infection with the high-risk types of HPV that can cause cervical cancer. Last year, the FDA greenlit similar self-collection cervical cancer screening kits for use in a medical setting, such as at a doctor's office, an urgent care or even a mobile clinic. At the time, two health care businesses – biotechnology company Roche and medical technology firm Becton, Dickson and Company – said the FDA had approved the use of self-collected samples with their respective HPV tests. The Teal Health at-home kit allows a patient to collect their sample using the Teal Wand, which is then processed on Roche's HPV test, said Kara Egan, Teal Health's CEO. But a major difference is that the Teal Wand is approved to be used at home, so patients don't have to travel to or make time for in-person doctor appointments. To use Teal Health's new self-collection kit, 'you request a kit at the Teal website, meet with a provider who prescribes the kit, then comfortably and privately collect at home and mail to the lab to process on the Roche Cobas HPV test,' Egan said. 'The results are then reviewed by a clinician and shared back,' she said. 'If the results are positive, a provider will meet with you and refer you to any required follow-up.' Clinical trial data from Teal Health has found that self-collection with the Teal Wand has the same accuracy for cervical cancer screening as when a health care provider collects a sample, Egan said. 'It's the same test, same accuracy, but you can comfortably do it from home,' she said. 'It gives women more options, and with telehealth, we see more options to get access to care.' Teal Health plans to begin shipping its at-home self-collection kits in June, Egan said, starting in California before expanding nationwide. A waitlist is available at the company's website. Teal Health has been in talks with health insurance companies about having the self-collection kit covered, Egan added, and for people who don't have insurance, the cost of the kit will be announced within the next month. The American Cancer Society applauded the new FDA approval. 'Despite the benefits of cervical cancer screening, not all eligible are screened regularly,' Dr. William Dahut, the society's chief scientific officer, said in an email Friday. 'Most cervical cancers are found in people who have never had a cervical cancer screening test or who have not had one recently. That's why today's Food and Drug Administration's announcement approving the first at-home test to screen for cervical cancer as an additional cancer screening method for this potentially deadly disease will make a huge impact.' Some of the most important steps women can take to help reduce their risk for cervical cancer, according to the US Centers for Disease Control and Prevention, are to get vaccinated against HPV, avoid smoking, use condoms during sex, have regular screening tests and check with their doctor if their test results are not normal. It's estimated that about 1 in 4 adults are not up to date on cervical cancer screening recommendations, according to data from 2021. 'Some women are scared of a traditional pap smear or find the process uncomfortable, as a result they put off this vital test,' Dr. Ami Vaidya, co-chief of gynecologic oncology at Hackensack University Medical Center's John Theurer Cancer Center, said in a news release Friday. The newly approved at-home screening device 'could be an important tool in getting more women regularly screened, especially those that don't have access to a medical provider,' Vaidya said. 'Any type of test that helps detect cervical cancer is a win.' The US Preventive Services Task Force recommends screening for cervical cancer with cervical cytology – also known as a Pap test or Pap smear – every three years for women ages 21 to 29. For women 30 to 65, the USPSTF recommends screening every three years with cervical cytology alone, every five years with high-risk HPV testing alone, or every five years with high-risk HPV testing in combination with cytology. It's estimated that about 80% of people will get an HPV infection in their lifetime. HPV, a group of more than 150 viruses, is spread primarily through sexual contact and includes low-risk strains, which most often cause warts, and high-risk strains, which have been associated with an increased risk of certain cancers, such as cervical, anal, penile and oropharyngeal cancers. In most cases, HPV clears on its own within two years, but when the infection does not go away, health problems like cancer may occur. Screening for cervical cancer remains important because early cases often may not have signs or symptoms. Advanced cases may cause abnormal vaginal bleeding or unusual discharge. Cervical cancer is treated in many ways, including surgery, chemotherapy and radiation therapy.
CNN
09-05-2025
- Health
- CNN
FDA approves first cervical cancer screening device that can be used at home, company says
To get screened for cervical cancer, patients in the United States may no longer need to put their feet in those awkward stirrups, brace for the uncomfortable speculum or even take the time off from work for an in-person doctor's appointment. Soon, they will have the option to collect their own vaginal samples for screening from home – instead of a health care provider doing it for them. The US Food and Drug Administration has approved the first at-home self-collection device for cervical cancer screening in the United States, called the Teal Wand, according to the women's health company Teal Health. Last year, the FDA gave the company's Teal Wand 'breakthrough device' status, allowing the agency to review it on a faster timeline. Teal Wand, which will be provided in Teal Health's at-home self-collection kit, will require a prescription. Self-collected samples using the Wand are then mailed to a lab to be tested for HPV, the company announced Friday. Most cervical cancers are caused by human papillomavirus or HPV, and screening for HPV can help identify women who may be at risk of developing cervical cancer. Typically, when screening for cervical cancer, gynecologists collect samples for HPV testing, cervical cytology or both. Cervical cytology, also known as a Pap test or Pap smear, involves examining cervical cells for changes to detect precancerous or cancerous cells. The HPV test checks cells for infection with the high-risk types of HPV that can cause cervical cancer. Last year, the FDA greenlit similar self-collection cervical cancer screening kits for use in a medical setting, such as at a doctor's office, an urgent care or even a mobile clinic. At the time, two health care businesses – biotechnology company Roche and medical technology firm Becton, Dickson and Company – said the FDA had approved the use of self-collected samples with their respective HPV tests. The Teal Health at-home kit allows a patient to collect their sample using the Teal Wand, which is then processed on Roche's HPV test, said Kara Egan, Teal Health's CEO. But a major difference is that the Teal Wand is approved to be used at home, so patients don't have to travel to or make time for in-person doctor appointments. To use Teal Health's new self-collection kit, 'you request a kit at the Teal website, meet with a provider who prescribes the kit, then comfortably and privately collect at home and mail to the lab to process on the Roche Cobas HPV test,' Egan said. 'The results are then reviewed by a clinician and shared back,' she said. 'If the results are positive, a provider will meet with you and refer you to any required follow-up.' Clinical trial data from Teal Health has found that self-collection with the Teal Wand has the same accuracy for cervical cancer screening as when a health care provider collects a sample, Egan said. 'It's the same test, same accuracy, but you can comfortably do it from home,' she said. 'It gives women more options, and with telehealth, we see more options to get access to care.' Teal Health plans to begin shipping its at-home self-collection kits in June, Egan said, starting in California before expanding nationwide. A waitlist is available at the company's website. Teal Health has been in talks with health insurance companies about having the self-collection kit covered, Egan added, and for people who don't have insurance, the cost of the kit will be announced within the next month. The American Cancer Society applauded the new FDA approval. 'Despite the benefits of cervical cancer screening, not all eligible are screened regularly,' Dr. William Dahut, the society's chief scientific officer, said in an email Friday. 'Most cervical cancers are found in people who have never had a cervical cancer screening test or who have not had one recently. That's why today's Food and Drug Administration's announcement approving the first at-home test to screen for cervical cancer as an additional cancer screening method for this potentially deadly disease will make a huge impact.' Some of the most important steps women can take to help reduce their risk for cervical cancer, according to the US Centers for Disease Control and Prevention, are to get vaccinated against HPV, avoid smoking, use condoms during sex, have regular screening tests and check with their doctor if their test results are not normal. It's estimated that about 1 in 4 adults are not up to date on cervical cancer screening recommendations, according to data from 2021. 'Some women are scared of a traditional pap smear or find the process uncomfortable, as a result they put off this vital test,' Dr. Ami Vaidya, co-chief of gynecologic oncology at Hackensack University Medical Center's John Theurer Cancer Center, said in a news release Friday. The newly approved at-home screening device 'could be an important tool in getting more women regularly screened, especially those that don't have access to a medical provider,' Vaidya said. 'Any type of test that helps detect cervical cancer is a win.' The US Preventive Services Task Force recommends screening for cervical cancer with cervical cytology – also known as a Pap test or Pap smear – every three years for women ages 21 to 29. For women 30 to 65, the USPSTF recommends screening every three years with cervical cytology alone, every five years with high-risk HPV testing alone, or every five years with high-risk HPV testing in combination with cytology. It's estimated that about 80% of people will get an HPV infection in their lifetime. HPV, a group of more than 150 viruses, is spread primarily through sexual contact and includes low-risk strains, which most often cause warts, and high-risk strains, which have been associated with an increased risk of certain cancers, such as cervical, anal, penile and oropharyngeal cancers. In most cases, HPV clears on its own within two years, but when the infection does not go away, health problems like cancer may occur. Screening for cervical cancer remains important because early cases often may not have signs or symptoms. Advanced cases may cause abnormal vaginal bleeding or unusual discharge. Cervical cancer is treated in many ways, including surgery, chemotherapy and radiation therapy.
