1 articles · Updated · The Washington Post · Oct 30
Summary
Preliminary results from PinkDx’s multisite study show its clinician-collected vaginal swab detecting endometrial cancer with 90% or higher sensitivity and at least 50% specificity in symptomatic women.
Those thresholds could make the swab a first-step test that spares about half of patients from biopsy, while positives would still need biopsy and negatives would still require follow-up if bleeding persists.
3,000 participants are being enrolled across 16 U.S. sites to validate whether tumor DNA and RNA shed from the uterus can be reliably captured at the vaginal opening.
30% of endometrial biopsies in postmenopausal women fail to yield adequate tissue, underscoring demand for a less invasive option as endometrial cancer cases and deaths rise.
PinkDx expects the study to finish this year and aims to secure CMS lab certification by early 2027, allowing patient access by mid-2027 if results hold up.