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What to know about self-swabbing for HPV after FDA approves new kits

For the first time, women in the United States have the option of taking a sample themselves to test for human papillomavirus (HPV).

This week, the US Food and Drug Administration approved two self-swab tests made by global medical technology company Becton, Dickinson and Company (BD) and pharmaceutical company Roche Holding AG for “clinical” use , that is to say in a private room inside a medical office. mobile clinic or other health care facility.

The tests are not yet available for people to use at home.

HPV is the most common sexually transmitted infection in the United States and can lead to several life-threatening cancers, including cervical cancer.

Advocates hope that by having a less intrusive option, more women, especially those living in underserved areas, will be able to get tested for HPV.

Here’s what you need to know about the infection and the recently approved tests.

What is HPV?

HPV is a very common STI that infects about 13 million Americans each year, according to the Centers for Disease Control and Prevention. Almost everyone will get HPV at some point in their life, according to the CDC.

There are more than 100 types of HPV, and most HPV infections go away on their own within two years.

About 10% of infections last longer and can put individuals at risk of developing certain cancers, including cervical, vaginal, and vulvar cancer; penile cancer; anal cancer; and oropharyngeal cancer, which is cancer in the back of the throat, according to the CDC.

Each year, HPV causes about 37,000 cases of cancer in men and women in the United States, according to the federal health agency.

How do the new tests work?

Typically, HPV tests are performed by gynecologists, who take a small sample of cells from the cervix, which are then sent to a laboratory for analysis.

However, with these new tests, patients will be able to insert the tampon themselves, even in a primary care physician’s office. Once the swabs are sent to a laboratory, it will transmit the results to the prescribing doctor, who will then inform the patient.

BD and Roche say they expect self-collection from some healthcare providers to be available this summer, with companies needing three to four months to prepare and distribute kits and relevant information, said officials at ABC News.

“Cervical cancer in general should be completely eradicated from this planet, but it continues to persist,” Dr. Melissa Simon, an obstetrician at Northwestern University Hospital and director of the Center for Health Equity, told ABC News Transformation. “You can do it under your own control as part of…and feel safer collecting that sample.”

Companies ultimately want to make them available for home use. They say this could happen by the end of the year, pending FDA approval specifically for home collection.

Experts say self-collection will not replace regular HPV screenings by a qualified doctor, but it can expand access to testing and allow more women to get tested.

“Many patients are uncomfortable with the intimate nature of a pelvic exam,” said Dr. Jeff Andrews, board-certified gynecologist and vice president of global medical affairs for diagnostic solutions at BD, in a statement. Press. “Additionally, many people live in areas without a local doctor or clinician trained to obtain a sample with a speculum. The ability to self-collect in a clinical setting may help women overcome some of these barriers.”

How can I prevent HPV?

An HPV vaccine was approved by the FDA in 2006. The CDC currently recommends that children ages 11 to 12 receive two doses of the HPV vaccine, given six to 12 months apart, although children can receive the vaccine from the age of 9.

Anyone under 26 can receive the HPV vaccine if they are not fully vaccinated, according to the CDC.

The American Cancer Society and the American College of Obstetrics and Gynecology recommend that women ages 21 to 29 get a Pap test every three years.

It is recommended that women aged 30 to 65 be screened every five years with an HPV test or Pap and HPV co-test. This group may also have a Pap test on their own every three years.

Women aged 65 and older can stop the test if they do not have a history of cervical cancer or abnormal cervical cells and if their test results have been negative repeatedly over the past few years. last 10 years and the most recent test took place within the last five years.

Indira Khera of ABC News contributed to this report.

Sejal Parekh, MD is a practicing pediatrician and contributor to the ABC News Medical Unit.

News Source : abcnews.go.com
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