SEATTLE, WA (October 19, 2017) – VisionGate, Inc. reported significant findings in three recent studies at the 18th annual World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). These studies demonstrate important applications of the LuCED® Lung Test for detection and treatment of lung cancer and pre-cancerous bronchial dysplasia.
The results of these important studies demonstrate that VisionGate’s LuCED Lung Test is a non-invasive liquid biopsy sputum test that addresses critical unmet medical needs to advance the lung cancer diagnostic and treatment fields in three areas: 1) accurate detection of small tumors and pulmonary nodules; 2) detection and treatment of pre-cancerous dysplasia; and 3) detection of key lung cancer driver mutations.
The new bronchial dysplasia detection data illustrate the convergence of VisionGate’s diagnostic (Dx) and pharmaceutical (Rx) capabilities. The non-invasive LuCED lung test is the key enabling technology for identification of patients with the potential to benefit from VisionGate’s pharmaceutical lung cancer prevention drug Iloprost.
“These results further demonstrate the power of VisionGate’s patented technology to dramatically improve early detection, play a role in identification of patients for targeted therapy, and be a leader in cancer chemoprevention,” VisionGate’s Founder and CEO, Alan Nelson, PhD said. “Our data continues to prove that we are revolutionaries in the lung cancer disease area.”
LuCED Lung Test Sensitivity Confirmed Irrespective of Tumor Size
The purpose of this study was to assess the sensitivity of the non-invasive LuCED lung test across a range of tumor sizes including smaller, early-stage tumors. Sputum samples from 82 biopsy-confirmed lung cancer cases were studied. The study results demonstrated that VisionGate’s technology reliably identifies abnormal cells regardless of tumor size. This finding demonstrates that the LuCED lung test has clinical utility in the evaluation of smaller, earlier stage tumors including those in the 6 – 30 mm size commonly seen at clinical presentation, often characterized as indeterminate pulmonary nodules. Importantly, the LuCED lung test maintains consistently high specificity while providing 94% sensitivity to lung cancer.
Effect of Tumor Size on the Sensitivity of the Non-Invasive LuCED® Test For Lung Cancer (Abstract #9597)
Cell-CT Diagnostic Platform Distinguishes Bronchial Dysplasia Cells
This study reports the development of the LuCED-D (LuCED for Dysplasia) algorithm performed on VisionGate’s Cell-CT Imaging and Analysis Platform, as well as the ability to successfully distinguish bronchial dysplasia cells from normal and malignant cells in sputum samples with minimal false positive indications.
This early assessment revealed encouraging sensitivity and specificity to dysplasia and represents a first important step toward developing a non-invasive diagnostic test using a sputum liquid biopsy to detect endobronchial dysplasia – a pre-cursor lesion that can lead to development of lung cancer. The LuCED-D test is being developed as a companion diagnostic supporting the ongoing clinical development of Iloprost–VisionGate’s leading investigational drug to treat dysplasia and impact lung cancer prevention.
Cell-CT™ Differential Detection of Dysplastic Bronchial Epithelial Cells from Patient Explants (Abstract #10219)
Cell-CT Diagnostic Platform Distinguishes Cancer Cells by Mutation Status
This study revealed, for the first time, that the Cell-CT platform using 3-Dimensional cell morphology evaluation can sub-classify cancer cells not only by lung cancer type, but also by driver mutation profile. The Cell-CT platform was able to identify each of the five-studied lung cancer cell lines including Small Cell Lung Cancer (SCLC), and Non-Small Cell Lung Cancers (NSCLCs) exhibiting the important driver mutations or alterations EGFR, T790M, and ALK that
are treatable with targeted therapies.
This study demonstrates the feasibility of using VisionGate’s Cell-CT platform to accurately detect driver mutations associated with morphological alterations in cancer cells using sputum. This technology has the potential to enhance diagnostic identification of additional lung cancer patients eligible for personalized treatment with precision mutation-targeted therapies.
Morphometric Genotyping Identifies Lung Cancer Cells Harboring Target Mutations; Cell-CT™ Platform Detects Gene Abnormalities (Abstract #9491)
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VisionGate, Inc. is led by Dr. Alan Nelson, physicist, bioengineer and serial entrepreneur who previously developed the world’s first and only automated screening test to detect cervical cancer, marketed globally today as FocalPoint by Becton Dickinson. VisionGate is a clinical stage oncology pharmaceutical and diagnostics company focused on eradication of lung cancer. Our lead investigative pharmaceutical drug is Iloprost, currently in clinical development following a successful Phase 2 clinical trial for chemoprevention; ultimately to be paired with the LuCED lung test as a companion diagnostic to identify pre-symptomatic patients with lung dysplasia, a pre-cancerous condition. VisionGate’s proprietary LuCED lung test is a non-invasive liquid biopsy diagnostic test for detection of early-stage lung cancer, demonstrating exquisite sensitivity and specificity in blinded clinical studies. This non-invasive sputum test is processed on the world’s first automated 3D cell imaging and analysis technology, the Cell-CT platform, named aptly because it is similar in principle to taking a CT scan of individual cells, but using visible light without harmful radiation. With 168 issued patents in 13 countries, VisionGate expects to play a leading role in the battle against the world’s number one cancer killer.