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The first shipments of some self-assembled HPV tests to screen for cervical cancer are currently on their way to doctors' offices across the United States.
In May, the US Food and Drug Administration He gave the green light Instead of a traditional HPV test or Pap smear test, for cervical cancer screening patients have the option of collecting their own vaginal sample, which includes a speculum to diagnose the disease. Similar to how they collect their own urine samples, patients can now collect their own vaginal samples at a healthcare location such as a doctor's office, urgent care or pharmacy clinic.
So far, two health care businesses – a biotechnology company Roche And Medical Technology Company BD – You already have HPV tests that can be used with self-collected samples. Most cervical cancer screenings include testing for things like human papillomavirus or HPV Cervical cancer They are caused by a virus.
BD's self-collection HPV tests began Thursday, the company said. And Roche expects that. HPV self-assembly screening solution Will ship sometime this fall.
The hope is that offering a self-collection system will make screening more accessible to patients, leading to more women getting screened, said Dr. Jeff Andrews, a board-certified obstetrician and vice president of diagnostic solutions for global medical affairs at BD.
Each year in the United States, more than 11,000 new cases of cervical cancer are diagnosed and about 4,000 women die from the disease. US Centers for Disease Control and Prevention. It is assumed that About half of all cervical cancer cases Those who have not been diagnosed and 10% of those who have not been diagnosed before five years.
“We know that in other places in Europe, Australia, New Zealand, the addition of the self-collection option has reached some of the women who were previously being screened. So that's the main goal, is to develop a method that appeals to people with cervical cancer who are not screened,” Andrews said.
“Especially in the United States About 30% are women It is unfiltered or unfiltered,” he said. “These women are more prone to cervical cancer. About two thirds Cervical cancers occur in undiagnosed women In the time interval” as it is said, in the time interval when women are recommended to check.
of The US Defense Services Task Force advises. Cervical cancer screening Along with cervical cytology — also known as a Pap test or Pap smear — every three years for women ages 21 to 29. For women ages 30 to 65, the USPSTF recommends screening with cervical cytology every three years alone, high-risk HPV testing alone every five years, or high-risk HPV testing with cytology every five years.
Typically, gynecologists collect samples for HPV testing, cervical cytology, or both—and any screening method, where samples are collected, may make some patients feel uncomfortable with a speculum.
Cervical cytology involves examining cervical cells for changes to detect precancerous or cancerous cells. An HPV test determines whether cells are infected with the types of HPV that can cause cervical cancer. A combined HPV and Pap test uses both tests together to screen for both high-risk HPV and cervical changes.
It is supposed to be about. 80% of people get HPV infection During their lifetime. HPV, a A group of more than 150 virusesIt is primarily sexually transmitted, with low-risk strains that usually cause warts and high-risk strains that include cancers such as cervical, rectal, genital, and oropharyngeal cancer. In most cases, HPV goes away on its own within two years, however When the infection does not go awayHealth problems such as cancer may occur.
“Almost all cervical cancers are caused by persistent infection with certain types of HPV,” said Dr. Karen E. KnudsenCEO of the American Cancer Society He said in a press release released in May When the FDA approves the HPV self-collection test for cervical cancer screening. “Self-harvesting can expand access to screening and reduce barriers, giving more people the chance to be diagnosed, treated, and ultimately survive cancer.”
For some patients, having a provider collect a vaginal sample to screen for cervical cancer or an HPV test may be too painful or distressing. The screening process involves a patient spreading his legs and shaking his legs, as the doctor inserts a cold and metal speculum into the vagina, then scrapes cells from the cervix.
Many patients skip the recommended Pap tests to screen for cervical cancer because the traditional Pap smear test can be painful.
Studies suggest that there is Understanding that the Pap test causes pain Women are significantly less likely to schedule their first Pap test. But it is possible to reduce pain during a Pap test Increasing acceptance and adherence to cervical cancer screenings.
“If we can increase the rate of screening, we can decrease the rate of this cancer. Having another method or option to make screening more accessible and accessible is especially important for our uninsured and underserved population. Self-screening gives women that extra choice,” said Good Samaritan at Catholic Health. Dr. John Vulo, chair of the Department of Obstetrics and Gynecology at University Hospital Long Island and co-chair of Women's Health Services at Catholic Health, said in an email.
Although I believe it is important to offer this new choice to our patients, I am happy that the current recommendations should be used under the supervision of the provider so that the patient can properly discover and understand the benefits and limitations of this new test. ” Vulo said in part. “This allows us to give them another way to screen for cervical cancer and still be able to talk to the provider about other health issues that are part of the annual well-woman exam.”
For a self-assembled screening test, a medical professional must order the test for a patient, and “that should be sure that the person doing the test understands the results, so the person will now contact their provider,” Andrews said.
The order leads to the lab. The lab creates a self-assembly kit, which includes instructions, a six-inch swab, and the screening test itself. The device is sent to the patient's doctor's office. The patient uses the swab to self-collect a vaginal sample by inserting it three inches into the vagina—this can be done in the bathroom at the doctor's office—then the doctor's office sends the sample to a lab for processing. If the sample test is positive, the doctor will recommend further testing.
While the self-collection method is currently available in healthcare settings, companies hope that self-collection pouches will eventually be used in the home as well.
BD is working closely with the FDA to provide data to support the at-home use of self-collection tests, Andrews said.
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another company, Health of teaIt developed an at-home cervical cancer screening device called TelWand, which was given an “evidence device” rating by the FDA in May, allowing the agency to evaluate the device more quickly.
“The FDA's recognition of the Till Wand as a Breakthrough Device recognizes the important public health benefits of self-collection for cervical cancer screening in people who are under-screened or who do not participate in cervical cancer screening in clinics,” Trena Deppel said. Till Health's vice president of clinical and regulatory affairs; He said in a press release at the time..
No matter where it is done, cervical cancer screening is important because early cases often have no signs or symptoms. Advanced cases may cause abnormal vaginal bleeding or abnormal discharge. Cervical cancer is treated in different ways; These include surgery, chemotherapy, and radiation therapy.
Here are some of the most important steps women can take to help Prevention of cervical cancerAccording to the CDC, they should not smoke, get the HPV vaccine, use condoms during sex, get regular screenings, and see a doctor if the screening results are abnormal.