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EdenDx Assay Validated as Supportive Endometrial Cancer Triage Tool in Peer-Reviewed Study
EdenDx Assay Validated as Supportive Endometrial Cancer Triage Tool in Peer-Reviewed Study
ORANGE, CA / ACCESS Newswire / October 15, 2026 / Unlike most cancers, endometrial cancer is rising in incidence and mortality in the U.S., yet there is no population screening program or FDA-cleared noninvasive test to identify it early. Today, Gnosis, a CLIA- and CAP-accredited clinical laboratory, announced a peer-reviewed study in Gynecologic Oncology Reports providing early evidence that the biomarkers behind EdenDx, previously studied predominantly in Asian populations, perform in a cohort including U.S. patients. In cervical cytology specimens collected like a liquid-based Pap test, EdenDx demonstrated 96.8% specificity, which compares favorably with transvaginal ultrasound. In endometrial biopsy tissue from U.S. patients, it detected 85% of cancers with 90% specificity.
The American Cancer Society projects 68,270 new cases and 14,450 deaths in 2026 from endometrial cancer, the most common gynecologic cancer in the U.S. Between 2015 and 2019, mortality rose 1.9% per year, while incidence among Black women climbed 2.4% per year, nearly five times the rate among White women.
In April 2026, the American College of Obstetricians and Gynecologists (ACOG) began recommending tissue sampling alongside ultrasound for most patients with postmenopausal bleeding, even though biopsy yields insufficient tissue in about 31% of cases and more than nine in ten of these women do not have endometrial cancer. Other tools have limitations like transvaginal ultrasound with specificity ranges from 24% to 72%, and Pap cytology detects only 25% to 45% of cancers.
EdenDx (Early Detection for Endometrial Neoplasia) takes a different approach by detecting hypermethylation of CDO1 and CELF4, two genes associated with endometrial cancer, in a sample preserved in a standard ThinPrep® vial. Unlike ultrasound, its results do not depend on endometrial thickness, which varies with hormonal changes, and to the company's knowledge, it is the only CLIA laboratory-developed CDO1/CELF4 methylation test in the U.S.
Because these biomarkers had been studied predominantly in Asian populations, which differ in risk factors and genetics, the authors, Gnosis scientists Rojeet Shrestha, PhD, Bo-Ram Bang, PhD, and Safedin Beqaj, PhD, evaluated them in a cohort including U.S. patients. Cervical specimens from Singapore and California showed specificity consistent with the 86.6% to 98.8% range reported in prior studies, while biopsy tissue from 40 U.S. patients provided preliminary evidence of similar performance in U.S. patients.
A positive result raised the odds of cancer more than 22-fold, helping physicians prioritize which patients need a biopsy. In cervical specimens, the test detected 72.2% of cancers, including 82% of grade 1 tumors and 81% of endometrioid adenocarcinomas, the disease's most common forms.
The analytical results further support the test's use in routine clinical practice. EdenDx detected cancer DNA when cancer cells made up as little as 1.5% of a sample, with run-to-run variation below 10%. Results were unaffected by common vaginal infections, blood, semen, or over-the-counter vaginal products, and there were no false positives in specimens with HPV-related abnormal Pap results, metastatic ovarian cancer, or benign ovarian cysts.
"CDO1 and CELF4 methylation changes arise early in the development of endometrial cancer, in some cases before symptoms appear, and that is precisely what makes them so valuable diagnostically," said Dr. Safedin Beqaj, Laboratory Director at Gnosis. "EdenDx detects those changes directly in a routine cervical specimen, without relying on how cells look under a microscope. For a disease whose evaluation has long relied on tissue sampling alone, that represents a genuine advance."
EdenDx is intended for symptomatic women and those at elevated risk from abnormal uterine bleeding, obesity, chronic anovulation, Lynch syndrome, or Tamoxifen therapy, as well as premenopausal women, in whom ultrasound is less reliable. It requires no new equipment or workflow changes and supports, but does not replace, endometrial sampling for definitive diagnosis.
Because invasive procedures are often the first step in evaluation, health systems, OB/GYN practices, public health agencies, and research institutions can add EdenDx to routine care, offering patients a noninvasive option to help guide that decision. The study is available open access in Gynecologic Oncology Reports. To offer EdenDx or explore partnerships, visit www.gnosisdx.com or contact [email protected].
About Gnosis
Gnosis is a CLIA- and CAP-accredited clinical laboratory based in Orange, California, specializing in advanced testing for women's health, pharmacogenomics, and molecular diagnostics. Formerly Mountain View Medical Laboratory, Gnosis is a community-anchored, innovation-driven lab helping providers make confident decisions and connect patients to timely, effective care. Learn more at www.gnosisdx.com.
About INEX Innovate
Based in Singapore, INEX Innovate is a molecular diagnostics company focused on unmet clinical needs in women's and fetal health. Its proprietary technologies include epiHERA™, which powers EdenDx, and OvaCis®. Learn more at www.inex.sg.
Media Contact
Elizabeth Wood
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SOURCE: Gnosis
View the original press release on ACCESS Newswire
(K.Lee--TAG)
