Utepreva launches FDA-cleared endometrial sampler to support endometrial cancer detection

Utepreva LLC announced the launch of the Utepreva Endometrial Sampler, a patented and FDA 510(k)-cleared device designed to improve the collection of tissue and fluid for the early diagnostic evaluation of endometrial cancer. The single-use device utilizes a proprietary design that combines 3 mechanisms of action into a single sampling pass.

Uterine cancer is the most common gynecologic malignancy in the United States, and endometrial carcinoma accounts for the majority of these cases, Utepreva said in a news release.

According to the American Cancer Society, an estimated 68,270 new cases will be diagnosed this year. With survival rates of up to 95% when the disease is identified at an early stage, and below 20% in advanced disease, outcomes in the clinical setting are highly dependent on timing. Consequently, clinicians require tools that reliably obtain high-quality specimens at the earliest point of concern.

Integrated mechanisms for superior sampling

Traditional endometrial samplers often rely on a single mechanism, such as tissue disruption or suction alone, which can result in inconsistent sampling and the potential need for repeat procedures. The Utepreva Endometrial Sampler integrates 3 actions: gentle tissue disruption, controlled suction, and optimized absorption via a sponge tip.

In preclinical and design verification testing conducted by Medical Murray, the Utepreva device was compared to a “commercially available endometrial sampling device using a standardized model of simulated endometrial tissue.”

Utepreva captured a greater volume of simulated tissue and demonstrated more uniform disruption across the sampling surface, though specific data points were not included in the news release.

According to Utepreva, the suction generated by an internal plunger prevents sample loss, while the sponge tip absorbs additional cells and fluid. This collected material supports cytologic, histopathologic, and molecular analyses, enabling both cellular evaluation and advanced biomarker assessment.

The Utepreva Endometrial Sampler features a slim-profile wand to minimize discomfort during insertion and removal, as well as an integrated cervical guard to help prevent over-insertion, with the tip designed to reduce the risk of fundal trauma.

These features allow for an in-office procedure that is typically completed in approximately 20 seconds. The procedure can be performed without the need for dilation, sedation, or operating room resources, modernizing the office-based sampling experience.

Clinical applications and the future of screening

The device is currently recommended for use in symptomatic patients, such as those presenting with abnormal or postmenopausal bleeding, as well as women at elevated risk due to age, obesity, hormone exposure, or family history of endometrial, colon, or ovarian cancer.

Jeanetta Stega, MD, CEO of Utepreva LLC, said in the release: "Our mission is to save lives by expanding access to minimally invasive uterine evaluation and aiding clinicians in the detection of pre-cancer, when treatment is less invasive, and survival outcomes are significantly improved."

Stega noted that enhanced sampling technology could eventually lay the groundwork for broader evaluation strategies similar to routine Pap smears or mammography.

"By dramatically improving tissue capture in a simple office procedure, Utepreva aims to make a similar impact on pre-cancer detection to that of Pap smears and mammography," she said. "As clinical evidence continues to build, enhanced sampling technology could ultimately lay the groundwork for broader, earlier evaluation strategies in the future."

Reference:

Utepreva Introduces FDA 510(k)-Cleared Endometrial Sampler Designed to Support Early Detection of Endometrial Cancer. Utepreva. News release. Published April 22, 2026. Accessed April 22, 2026. https://www.prnewswire.com/news-releases/utepreva-introduces-fda-510k-cleared-endometrial-sampler-designed-to-support-early-detection-of-endometrial-cancer