Phoenix, AZ, United States
Phoenix, AZ, United States
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A method of treating a malignancy in a human subject by analyzing pseudo-projection images of cells obtained from a sputum specimen obtained from a subject employs a biological specimen classifier that identifies cells from the sputum specimen as normal or abnormal. If abnormal cells are detected, then the abnormal cells are further classified as dysplastic or cancerous. If the cells are classified as dysplastic, then an immunomodulating agent is administered to the subject over a predetermined time period designed to achieve a therapeutic dosage.


News Article | June 7, 2017
Site: www.prweb.com

VisionGate, Inc. today announced the appointment of Dr. David Wilbur as Medical Director of its Phoenix-based CLIA laboratory, VisionGate Biosignatures Laboratory (VBL). A world-renowned pathologist, Dr. Wilbur comes to VisionGate from Massachusetts General Hospital (MGH), where he has been a practicing pathologist since 2001. He headed the Cytopathology Unit until 2011, when he took over the Pathology Department’s efforts in the emerging area of digital pathology and teleconsultation. He is also Professor of Pathology at Harvard Medical School. With interests in clinical cytology, digital pathology and computerized cell analysis and automation, Dr. Wilbur has been leading cutting-edge clinical digital pathology implementation at MGH. For several years, he also has been a consultant to VisionGate, providing final review and confirmation of all clinical cases utilizing VisionGate’s 3D cell imaging platform, the Cell-CT®. He has also authored VisionGate’s recent clinical and scientific publications. “After serving as a pathologist in a clinical setting for most of my career, I am very excited about joining VisionGate to help accelerate the impact of its game-changing, non-invasive LuCED® test for lung cancer as well as its chemoprevention drug Iloprost®,” VisionGate Medical Director Dr. David Wilbur said. “I’ve had the pleasure of working as a consultant to VisionGate for several years – reviewing hundreds of cases and thousands of cell images that VisionGate’s Cell-CT generates in 3D. It’s truly a ground-breaking technology that can help eradicate not only the world’s deadliest disease – lung cancer -- but other cancers as well.” For students studying cytology, Dr. Wilbur’s name may be especially familiar. In addition to being the co-editor of the 3rd and 4th editions of Comprehensive Cytopathology, he also authored multiple chapters in the textbook, and over a hundred scientific papers on cytology and cancer-related topics. Dr. Wilbur has practiced pathology at more than 10 hospitals and has taught at the University of Rochester and the University of Connecticut, along with Harvard. He’s served on several editorial boards including Cancer Cytopathology, Archives of Pathology and Laboratory Medicine, and CytoJournal. He’s also received the President’s Honor, Lifetime Achievement and Outstanding Service Awards from the College of American Pathologists. He is a past president of the American Society of Cytopathology. “As VisionGate prepares to enter the marketplace, Dr. Wilbur will provide his extensive expertise and leadership in pathology to the VBL,” VisionGate Founder and CEO Alan Nelson, PhD, said. “We so appreciate his longstanding technical and clinical guidance, and are thrilled he could join us here in Phoenix to oversee the day-to-day operations of the VBL. Dr. Wilbur will help bring VisionGate’s LuCED lung cancer test to the global market. With his leadership, we will be able to provide an early, life-saving diagnosis for patients who have lung cancer and preventive treatment to those at risk for lung cancer.” Dr. Wilbur is a graduate of Johns Hopkins University and earned his medical degree at the University of Rochester. He completed his postgraduate training at the University of Rochester and Hartford Hospital. 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’s proprietary LuCED®, test is a non-invasive diagnostic test for detection of early-stage lung cancer, demonstrating exquisite sensitivity and specificity in blinded clinical studies. This physician-ordered, take-home sputum test is processed on the world’s first automated 3D cell imaging platform, the Cell-CT®, named aptly because it is similar in principle to taking a CT scan of individual cells, but using visible light without harmful radiation. Moreover, with the exclusive patent license from the University of Colorado for the drug called Iloprost, VisionGate will drive the therapeutic market for chemoprevention of lung cancer and, ultimately, the eradication of this pervasive killer. With 166 issued patents in 13 countries, VisionGate expects to play a leading role in the battle against the world’s number one cancer killer.


News Article | December 15, 2016
Site: www.prweb.com

More than 1.5 million people in the United States will have suspicious nodules detected incidentally in their lungs this year. Additionally, roughly one-fourth of smokers over the age of 50 will have suspicious nodules detected on a low dose CT scan done in the setting of lung screening programs. However, less than 5 percent of those nodules will be diagnosed as cancerous(1). Knowing that nodules are more often not malignant, physicians are frequently faced with the quandary to “watch and wait” – see if the nodule grows over time – or perform additional, often invasive procedures. However, as demonstrated at the 17th World Conference on Lung Cancer (WCLC) last week in Vienna, Austria, VisionGate’s proprietary non-invasive LuCED test on sputum for the early detection of lung cancer may offer an alternative, non-invasive next step for patients. VisionGate’s blinded clinical study of the LuCED test included 139 patient specimens and demonstrated 90% sensitivity to lung cancer with a 97% specificity finding patients without the disease. “With each clinical milestone, we are encouraged by LuCED’s unparalleled performance,” VisionGate Founder and Chief Executive Officer Alan Nelson, PhD said. “If LuCED were able to help confirm or rule out cancer earlier in these patients – utilizing a non-invasive method – it would transform the way these incidental nodules are managed.” LuCED is a physician-ordered test performed at home. Three spontaneous sputum samples (phlegm) are collected and mailed to VisionGate’s laboratory in Phoenix. They are processed on VisionGate’s Cell-CT®, a platform that generates high-resolution 3D images of each cell in a sputum sample. It then automatically analyzes cells to identify 700 key features, or structural biomarkers, associated with malignancy. LuCED has the potential to be used to help triage incidental lung nodule findings, as an adjunct to low-dose CT in lung cancer screening to reduce false positives, and as a primary screener for lung cancer following FDA clearance. In a second presentation at the WCLC, LuCED also demonstrated promise in detecting bronchial dysplasia, a precursor to cancer. When dysplasia is detected, patients become candidates for chemoprevention drug therapies such as Iloprost. VisionGate and the University of Colorado are poised to embark on a Phase III clinical trial involving Iloprost to reduce dysplasia with LuCED as the tool to detect dysplasia. “We were very proud to present this compelling data at the WCLC last week. We are encouraged – now more than ever – that VisionGate is successfully developing cost-effective solutions to aid both physicians and patients in managing lung cancer, and eventually could be the missing link to eradicating the world’s deadliest cancer once and for all,” Nelson said. VisionGate is headquartered in Phoenix, AZ, with a Research & Development office in Seattle, WA. For more information about VisionGate, visit http://www.visiongate3d.com. About VisionGate® VisionGate, Inc. is led by Dr. Alan Nelson, physicist, bioengineer and 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’s proprietary LuCED test is a non-invasive diagnostic test for early-stage lung cancer, demonstrating exquisite sensitivity and specificity in blinded clinical studies. This physician-ordered, take-home sputum test is processed on the world’s first automated 3D cell imaging platform, the Cell-CT, named aptly because it is similar in principle to taking a CT scan of individual cells, but using visible light without harmful radiation. Moreover, with the exclusive patent license from the University of Colorado for the drug called Iloprost, VisionGate will drive the therapeutic market for chemoprevention of lung cancer and, ultimately, the eradication of this killer. With 146 issued patents in 13 countries, VisionGate expects to play a leading role in the battle against the world’s number one cancer killer. 1. Gould et al. Recent Trends in the Identification of Incidental Pulmonary Nodules. Am J Respir Crit Care Med Vol 192, Iss 10, pp 1208–1214, Nov 15, 2015


Patent
VisionGate | Date: 2012-02-22

A method for 3D imaging of cells in an optical tomography system includes moving a biological object relatively to a microscope objective to present varying angles of view. The biological object is illuminated with radiation having a spectral bandwidth limited to wavelengths between 150 nm and 390 nm. Radiation transmitted through the biological object and the microscope objective is sensed with a camera from a plurality of differing view angles. A plurality of pseudoprojections of the biological object from the sensed radiation is formed and the plurality of pseudoprojections is reconstructed to form a 3D image of the cell.


A cytological analysis test for 3D cell classification from a specimen. The method includes isolating and preserving a cell from the specimen and enriching the cell before embedding the enriched cell into an optical medium. The embedded cell is injected into a capillary tube where pressure is applied until the cell appears in a field of view of a pseudo-projection viewing subsystem to acquire a pseudo-projection image. The capillary tube rotates about a tube axis to provide a set of pseudo-projection images for each embedded cell which are reconstructed to produce a set of 3D cell reconstructions. Reference cells are classified and enumerated and a second cell classifier detects target cells. An adequacy classifier compares the number of reference cells against a threshold value of enumerated reference cells to determine specimen adequacy.


Patent
VisionGate | Date: 2010-08-24

An optical tomography system for viewing an object of interest includes a microcapillary tube viewing area for positioning the object of interest in an optical path including a detector. A motor is located to attach to and rotate a microcapillary tube. A device is arranged for transmitting broadband light having wavelengths between 550 nm and 620 nm into the microcapillary tube viewing area. A hyperchromatic lens is located to receive light transmitted through the microcapillary tube viewing area. A tube lens is located to focus light rays transmitted through the hyperchromatic lens, such that light rays from multiple object planes in the microcapillary tube viewing area simultaneously focus on the at least one detector.


Patent
VisionGate | Date: 2010-01-19

An optical tomography system includes a light field microscope including an objective lens, a computer-controlled light source, a condenser lens assembly and a microlens array aligned along an optical axis. A carrier containing a specimen is coupled to a rotational driver for presenting varying angles of view of the specimen. A photosensor array disposed to receive photons from the objective lens. A computer is linked to control the computer-controlled light source and condenser lens assembly and the rotational driver, and coupled to receive images from the photosensor array where the light field microscope simultaneously captures a continuum of focal planes in the specimen for each of a set of the varying angles of view of the specimen.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 188.23K | Year: 2010

DESCRIPTION (provided by applicant): The study of the tumor microenvironment promises to lead to groundbreaking strategies for the therapy of cancer. Unfortunately, progress of this research is impaired by the lack of available models that recapitulate key features of the interaction between tumor cells, stroma, and vasculature in a 3D in-vitro environment. The National Cancer Institute has identified the development of such models as a high priority. The long-term objective of this project is the development of a vascularized in-vitro model of the tumor microenvironment. The basic components of this model are a disposable, perfused microfluidic device with a viewing chamber filled with an extracellular-matrix gel. Tubular channels are created within the gel into which endothelial cells are introduced to form parent vessels. The parent vessels are capable of angiogenic sprouting and the formation of capillary-like networks. The design of the fluidic device allows for direct luminal perfusion of the engineered vessels and sprouts. Cancer cells can be integrated into this model in various ways for studies including metastasis, tumor-angiogenesis, and the screening of cancer therapeutics. In its commercial version, the system will be self-contained, comprising fluidic pumps, reservoirs for growth medium, sensors, and an array of microfluidic devices. Aim 1 will focus on the microfabrication and quality-control testing of a commercially-viable device for an in-vitro tumor microenvironment model. All devices will be characterized for their ability to create perfusable parent vessels and the associated angiogenic sprouts. Aim 2 will establish the utility of the device for the study of extravasation, which is the process of cancer cells breaking through the endothelial lining of the vasculature to form metastases. Extravasation will be measured as the number of cancer cells which break through the vascular sprouts into the extracellular matrix. Two prostate-cancer cell lines of different metastatic potential will be compared to a normal prostate cell line. The successful completion of these studies presents an important step toward the development of a new generation of tumor- microenvironment models that can be standardized and made commercially available to a broad community of researcher in academia and industry. PUBLIC HEALTH RELEVANCE: The study of the organ-specific environment in which tumors grow and spread is crucial for developing new cancer therapeutics. Unfortunately, progress is impaired by the lack of available research tools. We propose the development of a model that mimics the natural tumor environment, including perfused blood vessels and capillaries. We expect our model to become a valuable system in cancer research, commercially available to scientists in academia and industry.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 190.63K | Year: 2010

DESCRIPTION (provided by applicant): The blood-brain barrier (BBB) is a tight barrier formed by microvessels and capillaries controlling the passage of nutrients, fluids, metabolic products and drugs between the blood and the brain. Imbalance of the BBB is involved in a number of major pathologies afflicting the brain, such as Alzheimer's disease, stroke, and cancer. Although neurotherapeutics are among the largest and fastest growing markets in the pharmaceutical industry, progress is currently impaired by the lack of in-vitro assays that reliably predict in-vivo BBB permeability. None of the existing models adequately replicates the in-vivo organotypic microenvironment, which is seen as a key for achieving in-vivo-like functionality. We have previously developed a 3D model for the study of in-vitro angiogenesis, consisting of small fluidic devices with a collagen-filled chamber. We intend to advance our model into an organotypic in-vitro model of the blood-brain barrier with the following main attributes: (1) a tissue-engineered endothelial-cell microvessel, surrounded by pericytes and astrocytes arranged in physiological ratio and architecture; (2) direct contact between endothelial cells, pericytes, and astrocytes; (3) an extracellular matrix (ECM) that resembles the interstitial environment of the CNS; (4) luminal flow providing shear stress to the endothelium; (5) tightly-controlled physical and chemical conditions; (6) a mass- produced, disposable fluidic device that can be adapted for use in existing high-throughput analysis platforms. In Phase 1, we will establish the prototype of a model that comprises a central BBB-microvessel in a brain-specific extracellular matrix, surrounded by pericytes and astrocytes--cells that induce and maintain barrier tightness. In Phase 2 we will pursue the development of a commercial product, including the adaptation of the fluidic device to high- throughput analysis platforms. We predict that our model will facilitate a significant progress in the therapy of a number of devastating diseases. PUBLIC HEALTH RELEVANCE: A major obstacle to the successful development of drugs that treat diseases of the central nervous system (CNS) such as Alzheimer's, Parkinson's, stroke, brain cancers, and metastasis to the brain, is the inability of these drugs to cross the blood-brain barrier (BBB). This natural barrier, whose function is to protect CNS from potentially harmful molecules, unfortunately also prevents penetration of potentially beneficial drugs. The difficulty in assessing whether or not drugs will cross the BBB makes the development of new neurologic drugs a difficult and unusually unsuccessful task. For this reason, in- vitro models that successfully predict in vivo drug BBB-permeability are of paramount importance for the neuropharmaceutical industry. We propose the development of an in- vitro model that mimics the natural BBB architecture, including perfused microvessels This model promises to become a valuable system for drug developers as well as to CNS researchers in academia.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 202.36K | Year: 2011

DESCRIPTION (provided by applicant): Disregulated angiogenesis-the growth of new blood-vessels from existing vasculature-plays a central role in more than 70 major health conditions including cancer, cardiovascular disease, and macular degeneration. More than one billion people worldwide are afflicted by angiogenesis-dependent diseases. Therapeutics that target blood-vessel growth promise new possibilities in the treatment of devastating diseases and have vast economic potential. However, progress in translation from basic research into the clinic is slowed by the lack of dependable models for angiogenesis research and drug testing. Presently, none of the existing in-vitro models for the study of angiogenesis integrates most of the critical elements that typify vascular growth in vivo, and none of the existing models includes the growth of capillary sprouts from existing blood vessels under flow- which is by definition the hallmark of angiogenesis. Previously, we have developed tissue-engineering techniques for the creation of microvessels within small fluidic devices. Within these devices, we generate luminally-perfused parent vessels from endothelial cells that subsequently sprout and form anatomizing capillary-like networks in collagen. We now propose to develop this method into an advanced in-vitro angiogenesis model with the following attributes: (1) tissue-engineered parent vessels mimicking architecture and cell composition in vivo, capable of angiogenic sprouting into a surrounding three-dimensional matrix; (2) human-derived cells; (3) direct luminal perfusion of parent vessels and sprouts; (4) tightly-controlled physical and chemical conditions; and (5) a mass produced, disposable fluidic device that can be adapted for the use in existing high-throughput analysis platforms. Aim 1 of the proposed project will be the completion of an optimized design of the fluidic device and the establishment of a system that allows for the tight control of perfusion, temperature, gas concentration and pH within the device. Aim 2 will be to achieve established techniques for the generation of microvasculature with the three structural key components of angiogenesis: endothelial cells, pericytes, and basement membrane. Once feasibility is established, we plan to advance ourmodel into a standardized, easy to use product that can be of significant value in the development of therapies for a range of devastating diseases. PUBLIC HEALTH RELEVANCE: Disregulated growth of blood vessels is a central element in cancer andother important diseases. More reliable assays and models for the study of vascular growth and the evaluation of therapeutic drugs are necessary to improve clinical results. We propose a new model for the study of vascular functions that closer mimics natural vessels.

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