Pap smear at home? USA approve 1st device that allows home examination

To track cervical cancer, patients in the United States may no longer need to put their feet in those uncomfortable stirrups, prepare for the uncomfortable speculum or even get out of work for a face -to -face consultation.

Soon, they will have the option to collect their own vaginal samples for tracking at home – instead of a healthcare professional to do this for them.
The US Food and Drug Administration (FDA) approved the first home self -tracking device for cervical cancer in the United States, called Teal Wand, according to Teal Health Women’s Health Company. Last year, the Anvisa-like US regulatory body (FDA) granted the company’s Teal Wand the status of “innovative device”, allowing the agency to revise it on a faster schedule.

The Teal Wand, which will be provided at the Teal Health’s Home Self -Cymlet Kit, will require a prescription. Self-controlled samples using Wand are then sent by mail to a laboratory to be tested to HPV, the company announced on Friday. Most cervical cancers are caused by human papillomavirus (HPV), and tracking can help identify women who may be at risk of developing cervical cancer.

Usually, by tracking cervical cancer, gynecologists collect samples for HPV testing, cervical cytology or both. Cervical cytology, also known as Pap smear or preventive examination, involves the examination of cervical cells to detect changes that may indicate pre-caancer or cancerous cells. HPV test checks cells on high -risk HPV infection that can cause cervical cancer.

Last year, FDA approved similar self-tracking kits for cervical cancer tracking for use in a medical environment, such as a doctor’s office, emergency room or even a mobile clinic. At the time, two health companies – Roche biotechnology company and medical technology company Becton, Dickson and Company – said FDA had approved the use of self -controlled samples with their respective HPV tests.

The Teal Health’s home kit allows the patient to collect her sample using Teal Wand, which is then processed in the Roche HPV test, said Kara Egan, CEO of Teal Health. But a big difference is that Teal Wand is approved to be used at home so that patients do not need to travel or reserve time for face -to -face consultations.

“You can do it comfortably at home”

To use Teal Health’s new self -centered kit, “You request a kit on the Teal website, you meet a professional who prescribes the kit, then collectably collects and privacy at home and sends to the laboratory for processing at Roche Cobas HPV test,” said Egan.

“The results are then reviewed by a doctor and shared back,” she said. “If the results are positive, a professional will meet with you and refer you to any necessary follow -up.”

Teal Health’s clinical trial data found that the self -core with Teal Wand has the same accuracy for cervical cancer tracking as sample collection by a healthcare professional, Egan said. “It’s the same test, the same accuracy, but you can do it comfortably at home,” she said. “This offers more options to women and, with Telehealth, we see more options for gaining access to care.”

Teal Health plans to start sending its home self -tile kits in June, Egan said, starting with California before expanding to the entire country. A waiting list is available on the company’s website. Teal Health has been talking to health insurance companies about the coverage of the AutoColeta kit, added Egan, and for people who have no insurance, the cost of the kit will be announced within next month.

The American Cancer Society applauded FDA’s new approval. “Despite the benefits of tracking of cervical cancer, not all eligible people are regularly traced,” said Dr. William Dahut, the society’s scientific director, in an email.

“Most cervical cancers are found in people who have never done a cervical cancer tracking test or who did not recently. This is why today’s ad and Drug Administration announcement by approving the first house test to track cervical cancer as an additional method of tracking on this potentially deadly disease will have a huge impact.”

Methods for tracking cervical cancer

Some of the most important measures that women can take to help reduce the risk of cervical cancer, according to US illness control and prevention centers, are vaccinated against HPV, avoiding smoking, using condoms during gender, having regular tracking tests and consulting your doctor if the test results are not normal.

It is estimated that about 1 in 4 adults are not up to date with cervical cancer tracking recommendations, according to 2021 data.
“Some women are afraid of a traditional Pap smear or find the process uncomfortable and, as a result, postpon this vital test,” said Dr. Ami Vaidya, the JOHN Theore Cancer Cancer Codology codire of the Hackensack University Center, in a press release.

The newly approved home tracking device “could be an important tool to make more women regularly tracked, especially those who do not have access to a medical professional,” said Vaidya. “Any type of test that helps detect cervical cancer is a victory.”

The US Preventive Service Task Force recommends tracking of cervical cervical cancer with cervical cytology-also known as Pap smear or preventive examination-every three years for women aged 21 to 29 years. For women aged 30 to 65, USPSTF recommends tracking every three years only with cervical cytology, every five years with high -risk HPV testing only or every five years with high -risk HPV test in combination with cytology.

It is estimated that about 80% of people will against an HPV infection in their lives. HPV, a group of more than 150 viruses, is mainly transmitted by sexual contact and includes low -risk strains, which usually cause warts, and high -risk strains, which have been associated with an increased risk of certain cancers, such as cervical, anal, penile and oropharyngeal cancer. In most cases, HPV disappears alone within two years, but when the infection does not disappear, health problems such as cancer may occur.

Cervical cancer tracking remains important because early cases may often not show signs or symptoms. Advanced cases may cause abnormal vaginal bleeding or unusual discharge. Cervical cancer is treated in many ways, including surgery, chemotherapy and radiotherapy.

HPV: More than 36 million women do not take preventive exam, says study

Was this content originally published in Pap smear at home? USA approve 1st device that allows home examination on the CNN Brazil website.

Source: CNN Brasil

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