A new test could transform endometrial cancer diagnosis
A new test may offer an effective, accessible, and non-invasive way to diagnose endometrial cancer, sparing many women from a painful biopsy, the current gold standard.
Endometrial cancer is the most common gynecologic cancer, originating in the lining of the uterus, called the endometrium, according to StatPearls, an online library published in the National Library of Medicine.
The American Cancer Society estimates that approximately 70,000 new cases of endometrial cancer will be diagnosed in the U.S. in 2026, and more than 14,000 people will die from the disease.
Current tests for endometrial cancer often rely on procedures like transvaginal ultrasound and tissue biopsy to evaluate the uterine lining, methods that some women find stressfully uncomfortable.
The new test, developed by PinkDx, is quick, straightforward and painless, according to the company.
PinkDx says early results for accuracy have been very positive, and it has now started clinical validation trials in 12 major medical centers including Mayo Clinic and Columbia University. If the studies go as planned, the swabs may be available across the U.S. as soon as mid-2027.
"A clinician would take a swab of the vagina," Giulia Kennedy, Ph.D., co-founder and chief scientific officer of PinkDx, explained to ABC News. "No speculum needed."
The swab sample is then shipped to the PinkDx lab in California, and the genetic material is evaluated within two weeks, Kennedy said. A specialized algorithm classifies samples as either positive or not positive for endometrial cancer.
The results guide next steps: A positive test prompts timely confirmation and treatment planning, while a negative result allows clinicians to pursue other causes of symptoms without immediate invasive procedures.
However, the vaginal swab is only meant to be used for women who have abnormal vaginal bleeding as a symptom, the most common red flag for endometrial cancer, said PinkDx co-founder and CEO Bonnie Anderson. The test is not intended for women without symptoms and is unlikely to become a standard screening test for all women.
The vast majority of women diagnosed with endometrial cancer are postmenopausal, with the average age of diagnosis being 63, according to Dr. Kemi Doll, a gynecologic oncologist and uterine cancer specialist at the University of Washington.
More than 90% of these cases present with abnormal uterine bleeding. This can mean bleeding that returns after menopause. For younger women, however, it can also mean irregular bleeding -- either too heavy or too frequent.
According to the American College of Obstetricians and Gynecologists, a normal cycle is between 21 and 35 days, and period bleeding should last for no more than seven days.
Bleeding through a tampon or pad in less than 1 hour, passing large clots, or requiring blood transfusions should prompt discussion with your gynecologist or primary care physician, ACOG advises. Other symptoms include pelvic pain, urinary frequency, and fatigue.
Cervical cancer has seen a drastic decline with the introduction of routine Pap smears and the HPV vaccine, but endometrial cancer is on the rise, Doll said.
"One in 32 women will be diagnosed with endometrial cancer by the age of 80," she told ABC News. "By 2050, that number will be 1 in 17".
But it's not just that endometrial cancer is becoming more common, said Doll, who is the author of the upcoming book, "A Terrible Strength: The Hidden Crisis of the Black Womb and Your Survival Guide to Healing." It's becoming more aggressive, especially for Black women and other women of color.
"Black women have a 100% higher rate of death [from endometrial cancer] compared to white women," Doll said.
Kennedy and Anderson shared concerns about this disparity.
"We were very aggressive about adding as much diversity as possible [when developing this technology] -- 30% of the clinical trial participants were women of color," Kennedy said.
"We founded PinkDx to address an unmet need," Anderson told ABC News. "The current tools for diagnosis for endometrial cancer can be invasive, uncomfortable and anxiety-provoking."
The goal of the new test, Anderson said, is to make it easier for women to tolerate and to help doctors make faster, more accurate decisions about endometrial cancer, so patients can get the right treatment sooner.
Chidimma Acholonu, M.D., MPH, is a pediatric emergency medicine fellow at Children's National Hospital in Washington, D.C., and a member of the ABC News Medical Unit.
