A California company is testing whether a clinician-collected vaginal swab can help identify endometrial cancer in women with abnormal bleeding, potentially reducing the need for an invasive biopsy in some cases.
The test, developed by PinkDx, is being evaluated at 16 U.S. sites. It is intended for people who already have symptoms that can warrant investigation, including bleeding after menopause; it is not described as a population screening test.
A less-invasive diagnostic path
Endometrial cancer begins in the lining of the uterus. Clinicians commonly assess possible disease with transvaginal ultrasound and, when necessary, an endometrial biopsy. A biopsy involves passing a narrow instrument through the cervix to collect tissue from inside the uterus, a procedure that can be painful.
Biopsies can also be inconclusive when enough tissue cannot be obtained. The source report says this happens in about 30% of postmenopausal women, including cases in which the uterine lining is thin or the cervix is too narrow for the sampling instrument.
PinkDx’s approach looks for genetic material shed by dying cancer cells. That material can travel into the vagina, where it may be collected with a swab and analyzed in a laboratory.
Early evidence, larger study needed
An initial study involving 27 women undergoing hysterectomy detected the tumor-related signal in swabs taken even from the vaginal opening. That result is preliminary and requires confirmation in a substantially larger, independent group.
The ongoing study is expected to enroll about 3,000 women. Company officials told The Washington Post that early results were tracking toward the study’s aims, but the report does not provide final performance data.
The stated target is to detect at least 90% of cancers while correctly ruling out cancer in at least half of people who do not have it. The latter measure is important because a test that produces too many false positives could still lead many patients to further invasive procedures.
Why the need is pressing
The report notes that endometrial cancer death rates are rising, in part because aggressive forms of the disease are becoming more common. Any new diagnostic tool would therefore need to demonstrate both reliable cancer detection and a practical role alongside existing clinical assessment.
For now, the vaginal-swab method remains investigational. If a larger study validates its performance, it could offer clinicians another way to triage symptomatic patients and potentially spare some from a biopsy as the first diagnostic step.
This article is based on reporting by Medical Xpress. Read the original article.
Originally published on medicalxpress.com
