Groundbreaking Study Validates DEX-G2 Blood Test for Early Gastric Cancer Detection

A recent multicenter clinical study published in JAMA Surgery has confirmed significant advancements in early gastric cancer detection through the use of Cizzle Bio's DEX-G2 blood test. This study marks a monumental step forward in cancer diagnostics, particularly when considering the often-late diagnosis of one of the world's deadliest cancers.

The evaluation, known as the DESTINEX study, involved leading cancer centers in Japan and South Korea, and provided compelling data regarding the test's effectiveness. The study encompassed an analysis of 809 serum samples collected from 480 participants, which included individuals diagnosed with gastric cancer as well as matched controls. Leveraging machine learning, researchers were able to enhance and validate the performance of the DEX-G2 test, achieving an exceptionally high level of diagnostic accuracy.

About the DEX-G2 Blood Test

The DEX-G2 blood test is based on the Destinex assay, which utilizes a signature panel of microRNAs derived from exosomes and cell-free serum. These molecules are significant as they exhibit a unique profile that can indicate the presence of gastric cancer, particularly in its early stages. The study findings revealed a remarkable area under the curve (AUC) of 96.8% in the validation cohort, underscoring the test's strong diagnostic abilities with a sensitivity of 95.0% for early-stage gastric cancer (pT1).

Ajay Goel, Ph.D., AGAF, who led the study and is a renowned authority in cancer biomarker research, remarked, “The DEX-G2 assay combines the sensitivity of cell-free microRNAs with the specificity of exosomal markers, offering a method that is minimally invasive and highly accurate for detecting gastric cancer at an early stage when patient outcomes can be improved.”

The Clinical Urgency

Gastric cancer statistics paint a grim reality: it is the third leading cause of cancer-related death globally, primarily due to delays in diagnosis. With over 60% of cases diagnosed at advanced stages, where curative options are limited, the development of a reliable early detection method like the DEX-G2 blood test is imperative. Existing procedures like endoscopy have proven effective in reducing mortality rates in countries such as Japan and Korea, but issues such as cost, invasiveness, and accessibility hinder its widespread implementation.

Minimally invasive blood tests like DEX-G2 present a promising solution to bridge this gap. The Destinex assay has demonstrated robust sensitivity and specificity across tumor stages, solidifying its position as a potential game changer in the fight against early-stage gastric cancer. Additionally, the study confirmed a significant decline in biomarker levels following surgical tumor removal, further establishing the DEX-G2’s specificity for cancer detection.

Looking Ahead

Cizzle Bio is now focusing on advancing the DEX-G2 test for commercial deployment in CLIA-certified laboratories, targeting primary care physicians and gastroenterologists who currently have limited options for early gastric cancer detection. “This study reinforces the credibility and clinical utility of DEX-G2,” said Bill Behnke, CEO of Cizzle Bio, expressing pride in the firm’s commitment to providing early detection solutions for a disease that too often goes unnoticed until it's too late.

As Cizzle Bio aims for commercialization in both U.S. and international markets, the company envisions making earlier diagnostic capabilities accessible to populations disproportionately affected by late-stage gastric cancer diagnoses. Armed with a worldwide exclusive license for the DEX-G2 assay, Cizzle Bio is dedicated to revolutionizing cancer diagnostics and enhancing patient outcomes through innovative biomarker-based tests.

About Cizzle Bio

Cizzle Bio, headquartered in Texas, is a biotechnology enterprise specializing in the development and commercialization of biomarkers for the early detection of cancers. With a mission to empower patients and clinicians, the company is pioneering efforts in cancer diagnostics, striving to make significant strides in improving patient care and survival rates.

For more detailed information, please visit their official website at Cizzle Bio.