New FDA-Cleared Device Aims to Revolutionize Endometrial Cancer Detection

NEW YORK, NY – April 22, 2026 – As rates of uterine cancer continue a troubling ascent in the United States, a new medical device has received federal clearance, promising to enhance the early detection of this deadly disease. Utepreva LLC today announced the launch of its Utepreva Endometrial Sampler, a single-use device that recently gained 510(k) clearance from the U.S. Food and Drug Administration. Engineered to obtain a more comprehensive tissue sample from the uterine lining, the device aims to arm clinicians with a more powerful tool in the fight against endometrial cancer, where early diagnosis is the most critical factor for survival.

The FDA's decision, logged under number K240595 on August 14, 2024, clears the path for the sampler's market entry. It is designed to address the longstanding limitations of conventional sampling methods, which can often yield insufficient tissue and lead to diagnostic delays or the need for more invasive follow-up procedures.

A Growing Crisis in Women's Health

Endometrial cancer, the most common type of uterine cancer, represents a significant and growing public health challenge. It is one of the few cancers in the U.S. where both incidence and mortality are rising. The American Cancer Society projects that an estimated 68,270 new cases will be diagnosed this year alone. The disparity in outcomes based on the timing of diagnosis is stark: when caught in its earliest stages, the five-year survival rate is as high as 95%. However, if the cancer spreads before it is found, that rate plummets to below 20%.

Despite these alarming statistics, there is no routine screening protocol for endometrial cancer in asymptomatic women, unlike the Pap smear for cervical cancer or mammography for breast cancer. Current guidelines from leading medical bodies like the American College of Obstetricians and Gynecologists (ACOG) primarily recommend endometrial biopsy for patients who are already symptomatic—presenting with abnormal or postmenopausal bleeding—or those at high risk due to factors like obesity, age, or family history. For these women, a timely and accurate diagnosis is paramount. This diagnostic paradigm places immense pressure on the initial biopsy to be effective, as a missed or delayed diagnosis can have devastating consequences.

A Triple-Action Approach to Superior Sampling

The Utepreva Endometrial Sampler enters a market long dominated by tools that rely on a single mechanism, such as suction curettes like the common Pipelle or simple brush-based devices. While widely used, these traditional instruments can sometimes fail to collect an adequate sample, requiring patients to undergo repeat procedures. Utepreva’s innovation lies in its proprietary design, which uniquely integrates three complementary mechanisms of action in a single pass.

The device works by first using a brush to gently disrupt tissue from the uterine wall. Simultaneously, it employs controlled suction generated by a plunger to aspirate cells and tissue fragments into the collection chamber, preventing sample loss. Finally, a soft, optimized sponge tip at the end of the device absorbs surrounding cellular fluid, capturing additional diagnostic material. This triple-action approach is engineered to maximize the quantity and quality of the collected specimen.

Preclinical and design verification testing, conducted on behalf of the company by the medical device manufacturer Medical Murray, validated this design. In a controlled laboratory setting using a standardized model of simulated endometrial tissue, the Utepreva sampler was compared against a commercially available device, the Tao Brush, which was also its predicate device for FDA clearance. The results showed that Utepreva's device captured a statistically significant greater volume of tissue and demonstrated more uniform tissue disruption across the entire sampling surface. The comprehensive sample it collects is suitable for a full range of analyses, including cytology, histopathology, and advanced molecular and biomarker assessments, all from a single, minimally invasive procedure.

Prioritizing Patient Comfort and Procedural Efficiency

Beyond diagnostic efficacy, patient experience was a central focus in the device's development. Many women experience significant anxiety and discomfort associated with endometrial biopsies. The Utepreva sampler was engineered to mitigate these issues. It features a slim-profile wand to minimize discomfort during insertion and an integrated cervical guard to help prevent over-insertion and reduce the risk of uterine perforation. Furthermore, the soft sponge tip not only aids in sample collection but is also designed to reduce the risk of trauma to the uterine fundus.

The result is a procedure that can be completed in an office setting in approximately 20 seconds, without requiring cervical dilation, sedation, or the resources of an operating room. By making the diagnostic process faster, safer, and more comfortable, the device has the potential to improve patient compliance and reduce barriers to care.

Disrupting Diagnostics and Envisioning a New Standard

The Utepreva Endometrial Sampler is set to become available to healthcare providers in October 2026. Initially, it is recommended for the existing standard-of-care population: symptomatic and high-risk women. However, the company's vision extends far beyond this initial application. By providing a reliable, comfortable, and efficient sampling method, the technology could lay the foundation for a paradigm shift in uterine cancer detection.

"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," said Dr. Jeanetta Stega, CEO of Utepreva LLC.

The company will showcase its technology at the upcoming ACOG Annual Clinical & Scientific Meeting in May, aiming to build awareness and encourage adoption among the specialists on the front lines of women's health. The ultimate goal, as suggested by the company, is to generate enough clinical evidence to support broader use.

"As physicians, we've seen firsthand how improved screening tools revolutionize patient outcomes," Dr. Stega noted. "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. As clinical evidence continues to build, enhanced sampling technology could ultimately lay the groundwork for broader, earlier evaluation strategies in the future."