On October 6, 2022 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported the publication of a manuscript in Gynecologic Oncology, found here, validating the performance of its personalized molecular residual disease (MRD) test, Signatera, in epithelial ovarian cancer (EOC) (Press release, Natera, OCT 6, 2022, View Source [SID1234621804]). This study adds to the growing library of over 30 published clinical studies incorporating Signatera technology.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The blinded, multi-site study analyzed 163 plasma samples from 69 patients with Stage I-IV disease across a range of histologies, including high-grade serous (54%), endometrioid (13%), clear cell (13%) and other (20%). Test performance was evaluated at multiple time points: pre-surgery, post-surgery prior to adjuvant treatment, and longitudinally every 3 months for up to 40 months after the completion of definitive therapy. With longitudinal testing, recurrence was detected with 100% sensitivity, 100% specificity, and an average lead time of 10 months ahead of imaging compared to 1 month for CA-125.
"Ovarian cancer is an aggressive disease with poor survival, especially in advanced stages. This study suggests that ctDNA analysis can provide clinicians with invaluable information regarding an individual patient’s prognosis," said Dr. Minetta C. Liu, Natera’s chief medical officer of oncology. "Furthermore, high sensitivity and a significant lead time in detecting recurrence before both CA-125 and surveillance imaging could elicit a meaningful impact on patient outcomes by informing timely treatment decisions for personalized disease management."
EOC is the most lethal gynecologic cancer worldwide.1 In the U.S., it is the fifth most common cancer type in women.2 The 5-year survival rate decreases significantly as stage increases3 and the majority of patients will recur, even when achieving complete remission with primary treatment.4
About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.