New swab test could spare some women a painful biopsy for endometrial cancer
· Medical Xpressby Ellyn Vohnoutka
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A simple vaginal swab may one day help women with abnormal bleeding learn whether they have endometrial cancer without first going through a painful biopsy.
The test, from California-based PinkDx, is being studied at 16 U.S. sites, The Washington Post reported. It's meant for women who already have symptoms, such as bleeding after menopause.
Endometrial cancer starts in the lining of the uterus. Doctors often check for it with a transvaginal ultrasound, which uses a probe in the vagina to measure that lining. They may also do an endometrial biopsy, scraping out a small tissue sample through a thin tube passed into the uterus.
Both can be painful. Biopsies also fail to collect enough tissue about 30% of the time in women past menopause, The Post reported. Sometimes the uterine lining is too thin, or the cervix is too narrow for the instrument.
Meanwhile, endometrial cancer death rates are on the rise. That's partly because aggressive forms of the disease are becoming more common, The Post noted.
"Of all the cancers, this is one that is getting more and more cases being diagnosed every year," Dr. June Hou, a gynecologic oncologist at Columbia University Irving Medical Center in New York City, told The Post. She's leading the PinkDx study there.
Dying cancer cells in the uterus shed bits of genetic material that carry the tumor's fingerprint. These fragments can drift down into the vagina, where a swab taken by a clinician can collect them for lab testing.
In an early test of 27 women having a hysterectomy, PinkDx found that signal even in swabs from the vaginal opening.
Dr. Nicolas Wentzensen, deputy director of the Clinical Genetics Branch at the National Cancer Institute, told The Post that the first effort was very small. Its findings still need to be confirmed in a larger, independent group, he said.
The current study plans to enroll about 3,000 women and is expected to wrap up this year. Company officials told The Post that early results are on target.
The goal is for the swab to catch at least 90% of cancers. It also needs to correctly rule out cancer in at least half of women who don't have it, which limits false alarms.
If those numbers hold, Wentzensen said, the swab could become a first step that spares "half of the population from doing the biopsy."
Women who test positive would likely still need a biopsy. Those who test negative should still follow up with their doctor to evaluate other causes of their symptoms.
Because PinkDx plans to run the test only in its own lab, it doesn't need U.S. Food and Drug Administration approval, The Post reported.
The company expects to finish certification with the Centers for Medicare & Medicaid Services by early 2027. That would allow the swab to reach patients by mid-2027.
Key medical concepts
Malignant Endometrial Neoplasm
Clinical categories
Obstetrics & gynecologyWomen's healthOncologyCommon illnesses & Prevention Who's behind this story?
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