Vaginal Swab May Replace Painful Cancer Biopsy

A simple vaginal swab test is under development to detect endometrial cancer, potentially sparing women from invasive and sometimes inconclusive biopsies. This innovative test, being studied at 16 U.S. sites, analyzes genetic fragments shed by cancerous cells in the uterus that drift into the vagina. Current diagnostic methods, including transvaginal ultrasounds and endometrial biopsies, can be painful and may fail to collect adequate tissue samples. Endometrial cancer death rates are increasing, with more aggressive forms becoming prevalent.

The PinkDx test is being evaluated in a study expected to enroll approximately 3,000 women. The goal is for the swab to accurately identify at least 90% of cancers while correctly ruling out cancer in over half of women without the disease. If these performance metrics are met, the swab could serve as an initial screening step, significantly reducing the number of women requiring a biopsy. Positive results would likely still necessitate a biopsy for confirmation, while negative results would prompt further medical evaluation for other causes of symptoms.

Company officials anticipate that the test could be available to patients by mid-2027, following certification with the Centers for Medicare & Medicaid Services. This development offers a promising, less painful alternative for diagnosing endometrial cancer, especially for women experiencing symptoms like post-menopausal bleeding.