FDA Approves Game-Changing Home Pap Smear Test: When Will It Be Available?

On Friday, the U.S. Food and Drug Administration took action
approved
an unprecedented at-home cervical cancer screening device aimed at offering a more convenient option for detection
Pap smear tests
.

Teal Health has developed this new test with the aim of enabling women who might face difficulties scheduling or reaching an in-person appointment with their gynecologist to still receive a cervical cancer screening. Usually, such screenings occur during yearly visits through the use of
Pap smear
(Other at-home vaginal tests have been cleared by the FDA for use, though these are typically intended for clinical settings.)

This year, approximately 13,500 cases of invasive cervical cancer will be identified in the U.S., with an estimated 4,320 women expected to succumb to the illness, according to projections.
American Cancer Society
The projections indicate that this condition is most commonly identified in females aged 35 to 44 years. Ideally, this screening would assist in detecting human papillomavirus (HPV), an infection known to lead to cervical cancer.

Here’s everything you should be aware of regarding the exam, along with important tips from an ob-gyn to remember.


Meet the expert

:
Christine Greves
, MD, serves as an obstetrician and gynecologist at the Winnie Palmer Hospital for Women and Babies located in Orlando, Florida.


What is the process of using the swab?

The test known as the Teal Wand involves using a sponge-like applicator (which is housed within a teal-colored wand) to collect samples from inside the vaginal area. Afterward, you place the swab in a provided container and send it off to a laboratory for analysis.

If your test indicates a positive result for HPV, which is associated with the onset of
cervical cancer,
You will be directed to a healthcare provider who may recommend either a conventional Pap test or perform what’s known as a colposcopy. This procedure involves examining your cervix with a specialized magnification tool, allowing the doctor to obtain a tissue sample for additional analysis.

If all these tests show satisfactory results, you can delay further screening for three to five more years.

Christine Greves
Dr. Smith, an ob-gyn at the Winnie Palmer Hospital for Women and Babies in Orlando, Florida, welcomes the new tool’s availability but emphasizes that it should not substitute for an annual examination, which encompasses various critical components.

During your Pap test, your physician typically conducts a manual examination to check for any polyps or growths, performs a breast exam, and discusses any irregularities related to menstruation. “A cervical polyp, which carries a heightened risk of cancer, may be detected through our physical assessment rather than just via a vaginal smear or an HPV test,” explains Dr. Greves. “While this doesn’t replace routine visits, it’s excellent news that initiatives aim to enhance screening capabilities for cervical cancer.”


When will it become accessible to everyone?

Teal Health asserts in a
press release
The firm intends to provide these kits to women beginning in June. Initially, it will launch in California with expansion to additional states happening as quickly as feasible. Currently, individuals can sign up for a waiting list; this will notify them when the device becomes accessible in their respective states.

The firm is collaborating with leading health insurance companies to develop “flexible payment plans” for acquiring the device. However, at present, the pricing remains uncertain.


What steps should I take to obtain one?

The Teal Wand is a prescribed item that requires ordering.

getteal.com

You will have to submit your request through an online platform and undergo a telehealth consultation with a physician prior to having a testing kit delivered to you. Afterward, you’ll collect a sample, send it back, and subsequently receive your results.

In conclusion, Dr. Greves emphasizes that maintaining one’s health is crucial for women. She states, “Ensure you prioritize yourself and take the necessary steps to keep your general well-being in check.”

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