A groundbreaking multicenter clinical study published in JAMA Surgery has validated the diagnostic performance of DEX-G2, Cizzle Bio's biomarker-based blood test for early gastric cancer detection. The DESTINEX study demonstrates that this minimally invasive liquid biopsy achieves exceptional accuracy in detecting one of the world's deadliest malignancies at its earliest and most treatable stages.
Study Design and Results
The DESTINEX study, conducted at leading cancer centers in Japan and South Korea, evaluated a signature panel of microRNAs derived from exosomes and cell-free serum. Researchers analyzed 809 serum specimens from 480 participants, including patients with gastric cancer and matched controls, using machine learning to refine and validate the assay.
The study achieved remarkable diagnostic performance metrics. DEX-G2 demonstrated an area under the curve (AUC) of 96.8% in the validation cohort, with a sensitivity of 95% for detecting early-stage (pT1) gastric cancer. The assay maintained high sensitivity and specificity in distinguishing individuals with gastric cancer from those without the disease, confirming its potential as both a screening tool and diagnostic aid.
"By combining the sensitivity of cell-free microRNAs with the specificity of exosomal markers, Destinex—and now DEX-G2—offers a minimally invasive, accessible, and highly accurate method for detecting gastric cancer at a stage when outcomes can be dramatically improved," said Ajay Goel, Ph.D., AGAF, the study's lead researcher and scientific advisor to Cizzle Bio.
Clinical Significance and Unmet Need
Gastric cancer represents a critical global health challenge as the third leading cause of cancer-related deaths worldwide. The disease's devastating impact stems largely from delayed diagnosis, with more than 60% of gastric cancer cases diagnosed at advanced stages when curative treatment is no longer an option and prognosis is poor.
Current screening approaches face significant limitations. While endoscopic screening has helped reduce mortality in high-incidence countries such as Japan and Korea, its cost, invasiveness, and limited availability make it impractical for widespread use in low-incidence regions. Many patients experience no symptoms in early stages, while others face barriers to accessing screening procedures.
The study findings validate DEX-G2's potential to address this critical gap. The diagnostic performance remained robust across tumor stages and patient subgroups, and biomarker levels dropped significantly after surgical tumor removal, confirming the assay's tumor specificity.
Commercial Development and Market Access
Cizzle Bio is advancing DEX-G2 for near-term commercial deployment in CLIA-certified laboratories, which will allow healthcare providers to begin offering the test to patients. The company holds worldwide exclusive licensing rights for DEX-G2 and is actively pursuing commercialization in both U.S. and global markets.
"This study reinforces the scientific credibility and clinical utility of the technology behind DEX-G2," said Bill Behnke, CEO of Cizzle Bio. "We are proud to advance this innovation into clinical practice, where it has the potential to make earlier detection a reality for patients who currently have few options for early detection."
The test is intended to support clinicians in detecting gastric cancer earlier, particularly in primary care and gastroenterology settings where endoscopy may not be accessible or practical. This positioning could significantly expand access to early detection capabilities for populations where gastric cancer is often diagnosed too late for curative treatment.
Technology Platform and Future Applications
DEX-G2 represents part of Cizzle Bio's broader platform of minimally invasive diagnostics designed to support patients and care teams with earlier answers and better outcomes. The Texas-based biotechnology company is dedicated to revolutionizing cancer diagnostics through biomarker-based blood tests, starting with early detection of lung and gastric cancers.
The validation of DEX-G2's diagnostic performance in JAMA Surgery marks a significant milestone in translating advanced biomarker research into clinical practice. As the company prepares for commercial launch, the focus remains on ensuring scientific integrity while delivering real-world solutions that improve access to early cancer detection when treatment options are most effective and outcomes can be significantly improved.
