-Independent Study Data Shows Noninvasive Test Could Eliminate the Biopsy Needle, Lower Patient Anxiety and Costs–
BOULDER, Colo., Sept. 10, 2018 (GLOBE NEWSWIRE) - Biodesix today announced newly published data showing the noninvasive BDX-XL2 test, currently in development, could reduce the number of unnecessary biopsies carried out on patients with benign nodules, as well as reducing the overall cost of care while lowering patient anxiety. Each year, approximately 1.6 million lung nodules are detected in the US and tools to effectively evaluate the risk of malignancy have been identified as an unmet need among treating physicians. In an effort to meet this need, Biodesix will launch a registry study for BDX-XL2 in lung nodules this Fall. The study will seek to confirm the performance of the clinically validated test in a community setting.
Yearly CT scans of high-risk lung cancer patients has led to an increase in the early diagnosis of lung cancer and an increase in the identification of pulmonary nodules. Yet, not all lung nodules are cancerous and the BDX-XL2 test has shown early promise in ruling out cancer through blood samples. The Pulmonary Nodule Plasma Proteomic Classifier (PANOPTIC) trial, published in CHEST this month, found that the BDX-XL2 biomarker could lead to a 40 percent reduction in invasive procedures on benign nodules.
Drs. Nawar Al Nasrallah, MD and Catherine R. Sears, MD of the Indiana University School of Medicine wrote in CHEST, “This trial [PANOPTIC] represents an important step in development of a molecular profile that will aid in classification of intermediate-risk nodules and hopefully avoid unnecessary procedures, anxiety, and costs.”
The BDX-XL2 biomarker is easily obtained as it is a blood-based classifier designed to identify low to moderate risk patients with a likely benign lung nodule. The classifier integrates plasma proteins with clinical risk factors associated with lung cancer. The PANOPTIC trial was a prospective, multicenter observational trial that evaluated the accuracy of BDX-XL2 at identifying benign lung nodules in patients with a pre-test probability of cancer (pCA) < 50%. Gerard Silvestri, MD and Nicole Tanner, MD of the Medical University of South Carolina’s Thoracic Oncology Research Group Division of Pulmonary and Critical Care Medicine served as principle investigators for the study. In distinguishing between malignant and benign nodules the BDX-XL2 classifier was associated with high sensitivity (97%) and high negative predictive value (98%). According to Drs. Nasrallah and Sears, “This was superior to a PET scan or other pretest prediction models, including the Mayo Clinic and Department of Veterans Affairs estimates.”
“At Biodesix we see a great need to provide tools for the early diagnosis of lung cancer and that can help guide treatment decisions for physicians and patients throughout the continuum of care,” said David Brunel, CEO for Biodesix. “BDX-XL2 should improve the management of patients who may have lung cancer with a simple blood test. We are working diligently to bring this test to market.”
The company will be launching the ORACLE Registry Study (Observational Registry Study to Evaluate the Performance of BDX-XL2 in Routine Clinical Use) later this year which will confirm the clinical utility of BDX-XL2 in a real-world environment.