A new vaginal swab test may help some women with abnormal bleeding avoid a painful uterine biopsy to diagnose endometrial cancer. 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. Since endometrial cancer originates in the uterus lining, standard detection methods, such as a transvaginal ultrasound or an endometrial biopsy, are often uncomfortable and invasive.
Current Diagnosis Methods
Biopsies also fail to collect enough tissue about 30% of the time in women past menopause, due to a thin uterine lining or a narrow cervix. Meanwhile, endometrial cancer death rates are on the rise, partly because aggressive forms of the disease are becoming more common.
Dr. June Hou, a gynecologic oncologist at Columbia University Irving Medical Center, is leading the PinkDx study and notes that endometrial cancer is one of the most common cancers being diagnosed every year. Dying cancer cells in the uterus shed bits of genetic material that carry the tumor’s fingerprint, which can be collected by a swab for lab testing.
The Swab Test
In a preliminary trial involving 27 women undergoing hysterectomies, PinkDx discovered that the swab could identify cancer-related genetic traces even when collected from the vaginal entrance. Dr. Nicolas Wentzensen, deputy director of the National Cancer Institute’s Clinical Genetics Branch, acknowledged the small sample size but stressed that larger validation studies are necessary.
The current study plans to enroll about 3,000 women and is expected to wrap up this year. Company officials report that early results are on target, with the goal of catching at least 90% of cancers and correctly ruling out cancer in at least half of women who don’t have it.
If proven effective, the swab could serve as an initial screening to help many women avoid biopsies altogether. However, positive results would still require follow-up biopsies, and negative outcomes should prompt further medical evaluation to address other potential causes of symptoms.
Availability and Certification
PinkDx intends to administer the test exclusively through its own laboratory, eliminating the need for FDA approval. The company anticipates Medicare & Medicaid certification by early 2027, potentially making the swab available to patients by mid-2027.
For more information about endometrial cancer, visit the National Cancer Institute. As the swab test becomes available, women may have more options for endometrial cancer testing, but they should not delay testing if they have symptoms now, as cancer caught early may have a better outcome.