Invicro

Biomarker is a “biological indicator” used to measure onset and progression of a disease or as a marker of drug safety such as body temperature, blood pressure and heart rate. Imaging biomarkers (i-Biomarker) are used at Imanova to:

Determine if the candidate drug reaches and engages the target
Quantify the relationship between administered dose and target engagement
Investigate the relationship between target and disease
Demonstrate dose-dependent functional effects of candidate drug
Define the ‘therapeutic window’ to optimise dose selection and minimise side effects
Imaging biomarkers have the advantage of being non-invasive and can be used for early detection of diseases, patient stratification, and provide an objective assessment for the response to treatment.

The main limiting factor for using molecular imaging studies for early stage drug development decision-making is the lack of available biomarkers. Imanova is an advocate of using imaging as an integral part of clinical research to help understand the basis of disease and in the support of the drug development process and has a dedicated i-Biomarker discovery and development service.

Imanova has developed and implemented 21 imaging biomarkers to Good Manufacturing Practice (GMP) standard since its inception. We have the capability and experience to help identify, evaluate, develop and implement biomarker candidates for use in both preclinical models and clinical (in humans) studies.

In addition to neurosciences, Imanova offers i-Biomarker development for other key therapeutic areas including oncology, inflammation, cardiology and respiratory diseases.

Quantitative Immunohistochemistry and immunofluorescence

Phosphor integrated dot (PID) are novel nanoparticles that provides uniform, stable and high-intensity fluorescence, providing sensitive and quantitative IHC while overcoming limitations of conventional immunofluorescent and immunohistochemical methods. PID imaging technology utilize standard IHC workflow allowing easy integration with existing antibodies and protocols as well as custom assay development. Fresh frozen and/or FFPE samples can be stained and analyzed. The workflow is automated thus reducing variance and making it highly consistent and reproducible. Importantly, the technique utilizes a versatile optical system and a dedicated image-processing software for PID quantitation on images. PIDs characteristics together with image processing, provides a quantitative diagnostic technology to measure the expression levels of target proteins on tissues.
We offer Quantitative IHC of various validated markers as well as custom assay validation to marker of interest.
Typical deliverables are whole slide images, high-resolution images of ROIs and image segmentation and quantitation with PID/cell output.
Staining instrumentation include: leica Bond Rx, Tissue-Tek Glas automated cover slipper, Hamamatsu NanoZoomer S60

Quantitative Immunohistochemistry and immunofluorescence

Phosphor integrated dot (PID) are novel nanoparticles that provides uniform, stable and high-intensity fluorescence, providing sensitive and quantitative IHC while overcoming limitations of conventional immunofluorescent and immunohistochemical methods. PID imaging technology utilize standard IHC workflow allowing easy integration with existing antibodies and protocols as well as custom assay development. Fresh frozen and/or FFPE samples can be stained and analyzed. The workflow is automated thus reducing variance and making it highly consistent and reproducible. Importantly, the technique utilizes a versatile optical system and a dedicated image-processing software for PID quantitation on images. PIDs characteristics together with image processing, provides a quantitative diagnostic technology to measure the expression levels of target proteins on tissues.
We offer Quantitative IHC of various validated markers as well as custom assay validation to marker of interest.
Typical deliverables are whole slide images, high-resolution images of ROIs and image segmentation and quantitation with PID/cell output.
Staining instrumentation include: leica Bond Rx, Tissue-Tek Glas automated cover slipper, Hamamatsu NanoZoomer S60

In support of providing in-vivo imaging services, inviCRO’s histology and tissue imaging team has expertise in histology, IHC, quantitative whole-body autoradiography (QWBA), and micro- and immersion autoradiography, among other techniques. Notably, we have developed a method termed Cryo-Fluorescence Tomography (CFT) that enables 3D visualization of fluorescent compound distribution in frozen tissue. These studies are often included as an endpoint assessment for in vivo studies, expanding the value and information obtained. We have experience in many therapeutic areas – oncology, neuroscience, bone, ocular, renal, inflammation, cardiovascular.

Our histology facilities are fully-equipped with cryostats, whole-body cryomacrotomes for frozen sections, and microtomes for cutting paraffin and plastic sections (including EXAKT grinding system). We have expertise in IHC custom stain development, double or triple labeling on frozen and paraffin sections, as well as plastic sections.

inviCRO specializes in the development of novel image analysis methods, leveraging VivoQuant and other internal tools for the quantification of image features from digitized slides.

Our diverse team of experts has experience in instrument engineering, signal processing, and pharmaceutical R&D; collectively resulting in a long history designing and executing in imaging studies. Our scientists have run hundreds of imaging studies across multiple therapeutic research areas – oncology, neuroscience, inflammation, cardiovascular, metabolic, and musculoskeletal – and our experience runs the gamut of applications. We understand the physiological and biochemical mechanisms that affect imaging – targets, models, kinetics, etc. This vast experience allows us to understand drug behavior and translate knowledge to effective studies and useful data.

We define imaging as assays that enable visualization of subcellular distribution and processes all the way to translational and diagnostic clinical imaging biomarkers – and everything in between. With all imaging techniques, we use methods to ensure data is quantifiable, and leverage our powerful analytics platform to ensure that results can be used to drive meaningful decisions.

Studies may be single or multi-modal and may combine multiple isotopes or contrast mechanisms. When designing any study, we combine imaging theory, published methods, and the technical and professional expertise of our staff.

Our diverse team of experts has experience in instrument engineering, signal processing, and pharmaceutical R&D; collectively resulting in a long history designing and executing in imaging studies. Our scientists have run hundreds of imaging studies across multiple therapeutic research areas – oncology, neuroscience, inflammation, cardiovascular, metabolic, and musculoskeletal – and our experience runs the gamut of applications. We understand the physiological and biochemical mechanisms that affect imaging – targets, models, kinetics, etc. This vast experience allows us to understand drug behavior and translate knowledge to effective studies and useful data.

We define imaging as assays that enable visualization of subcellular distribution and processes all the way to translational and diagnostic clinical imaging biomarkers – and everything in between. With all imaging techniques, we use methods to ensure data is quantifiable, and leverage our powerful analytics platform to ensure that results can be used to drive meaningful decisions.

Studies may be single or multi-modal and may combine multiple isotopes or contrast mechanisms. When designing any study, we combine imaging theory, published methods, and the technical and professional expertise of our staff.

Our diverse team of experts has experience in instrument engineering, signal processing, and pharmaceutical R&D; collectively resulting in a long history designing and executing in imaging studies. Our scientists have run hundreds of imaging studies across multiple therapeutic research areas – oncology, neuroscience, inflammation, cardiovascular, metabolic, and musculoskeletal – and our experience runs the gamut of applications. We understand the physiological and biochemical mechanisms that affect imaging – targets, models, kinetics, etc. This vast experience allows us to understand drug behavior and translate knowledge to effective studies and useful data.

We define imaging as assays that enable visualization of subcellular distribution and processes all the way to translational and diagnostic clinical imaging biomarkers – and everything in between. With all imaging techniques, we use methods to ensure data is quantifiable, and leverage our powerful analytics platform to ensure that results can be used to drive meaningful decisions.

Studies may be single or multi-modal and may combine multiple isotopes or contrast mechanisms. When designing any study, we combine imaging theory, published methods, and the technical and professional expertise of our staff.

inviCRO’s chemistry team has expertise in radiolabeling a wide range of compounds including small molecules, peptides, oligonucleotides, proteins, nanoparticles and cells to support nonclinical and translational research. Utilizing both in-house expertise and facilities along with a network of collaborators and consultants, we have access to a renowned network of knowledge in the field.

inviCRO’s capabilities include:

Strategy and method development for radiolabeling small molecules, peptides, oligonucleotides, proteins, nanoparticles and cells
Synthesis of PET and SPECT radiopharmaceuticals for related in vivo imaging and in vitro assays
A dedicated state-of-the-art cyclotron facility for production of short-lived isotopes
Quality control and immunoreactivity assays for tracer validation
Cell and/or tissue binding and cell internalization assay method development

inviCRO’s chemistry team has expertise in radiolabeling a wide range of compounds including small molecules, peptides, oligonucleotides, proteins, nanoparticles and cells to support nonclinical and translational research. Utilizing both in-house expertise and facilities along with a network of collaborators and consultants, we have access to a renowned network of knowledge in the field.

inviCRO’s capabilities include:

Strategy and method development for radiolabeling small molecules, peptides, oligonucleotides, proteins, nanoparticles and cells
Synthesis of PET and SPECT radiopharmaceuticals for related in vivo imaging and in vitro assays
A dedicated state-of-the-art cyclotron facility for production of short-lived isotopes
Quality control and immunoreactivity assays for tracer validation
Cell and/or tissue binding and cell internalization assay method development

iPACS® is inviCRO’s web-based project management system designed for image study management applications. This platform allows for the efficient management, distribution, analysis and presentation of images and data associated with studies. The iPACS study management analysis software is a sophisticated, time-saving, web-based resource designed for imaging laboratories. iPACS offers a wide range of functionality for the organizational, processing, reporting and regulatory needs of preclinical and clinical imaging efforts. World-wide internet access allows users to collaborate seamlessly. User activity, such as electronic signatures and an audit trail ensuring the necessary information for 21 CFR Part 11 compliance, can be tracked in the iPACS with version control. The iPACS portal has been widely accepted in top 25 pharmaceutical companies as their primary image study management system. The iPACS platform is available in four versions: the iPACS Discovery, VisualSonics iPACS, iPACS Clinical and the iPACS GLP.

Our analytics platform lies at the heart of inviCRO’s unique capabilities. We employ a data-driven approach to study design and execution, which lends itself to meaningful data. Once the raw data are collected, inviCRO can leverage our computer science, biomedical engineering, mathematics, optics and image processing background for sophisticated analytics.

We have developed and validated analysis protocols across multiple imaging modalities, including but not limited to PET, SPECT, CT, MR, fluorescence, autoradiography, histology, and microscopy. These protocols have spanned numerous disease areas such as oncology, neurology, cardiology, and pulmonary in both the clinical and preclinical space.

Analysis and modeling can be customized to lab-specific efforts. We have built a team of analysts and developers covering a wide breadth and expertise and who pride themselves on both novel analysis development and fast, accurate turnaround for routine protocols. We can accommodate many applications, and studies of nearly any size.

In support of providing in-vivo imaging services, inviCRO’s histology and tissue imaging team has expertise in histology, IHC, quantitative whole-body autoradiography (QWBA), and micro- and immersion autoradiography, among other techniques. Notably, we have developed a method termed Cryo-Fluorescence Tomography (CFT) that enables 3D visualization of fluorescent compound distribution in frozen tissue. These studies are often included as an endpoint assessment for in vivo studies, expanding the value and information obtained. We have experience in many therapeutic areas – oncology, neuroscience, bone, ocular, renal, inflammation, cardiovascular.

Our histology facilities are fully-equipped with cryostats, whole-body cryomacrotomes for frozen sections, and microtomes for cutting paraffin and plastic sections (including EXAKT grinding system). We have expertise in IHC custom stain development, double or triple labeling on frozen and paraffin sections, as well as plastic sections.

inviCRO specializes in the development of novel image analysis methods, leveraging VivoQuant and other internal tools for the quantification of image features from digitized slides.

Our diverse team of experts has experience in instrument engineering, signal processing, and pharmaceutical R&D; collectively resulting in a long history designing and executing in imaging studies. Our scientists have run hundreds of imaging studies across multiple therapeutic research areas – oncology, neuroscience, inflammation, cardiovascular, metabolic, and musculoskeletal – and our experience runs the gamut of applications. We understand the physiological and biochemical mechanisms that affect imaging – targets, models, kinetics, etc. This vast experience allows us to understand drug behavior and translate knowledge to effective studies and useful data.

We define imaging as assays that enable visualization of subcellular distribution and processes all the way to translational and diagnostic clinical imaging biomarkers – and everything in between. With all imaging techniques, we use methods to ensure data is quantifiable, and leverage our powerful analytics platform to ensure that results can be used to drive meaningful decisions.

Studies may be single or multi-modal and may combine multiple isotopes or contrast mechanisms. When designing any study, we combine imaging theory, published methods, and the technical and professional expertise of our staff.

Our diverse team of experts has experience in instrument engineering, signal processing, and pharmaceutical R&D; collectively resulting in a long history designing and executing in imaging studies. Our scientists have run hundreds of imaging studies across multiple therapeutic research areas – oncology, neuroscience, inflammation, cardiovascular, metabolic, and musculoskeletal – and our experience runs the gamut of applications. We understand the physiological and biochemical mechanisms that affect imaging – targets, models, kinetics, etc. This vast experience allows us to understand drug behavior and translate knowledge to effective studies and useful data.

We define imaging as assays that enable visualization of subcellular distribution and processes all the way to translational and diagnostic clinical imaging biomarkers – and everything in between. With all imaging techniques, we use methods to ensure data is quantifiable, and leverage our powerful analytics platform to ensure that results can be used to drive meaningful decisions.

Studies may be single or multi-modal and may combine multiple isotopes or contrast mechanisms. When designing any study, we combine imaging theory, published methods, and the technical and professional expertise of our staff.

Our diverse team of experts has experience in instrument engineering, signal processing, and pharmaceutical R&D; collectively resulting in a long history designing and executing in imaging studies. Our scientists have run hundreds of imaging studies across multiple therapeutic research areas – oncology, neuroscience, inflammation, cardiovascular, metabolic, and musculoskeletal – and our experience runs the gamut of applications. We understand the physiological and biochemical mechanisms that affect imaging – targets, models, kinetics, etc. This vast experience allows us to understand drug behavior and translate knowledge to effective studies and useful data.

We define imaging as assays that enable visualization of subcellular distribution and processes all the way to translational and diagnostic clinical imaging biomarkers – and everything in between. With all imaging techniques, we use methods to ensure data is quantifiable, and leverage our powerful analytics platform to ensure that results can be used to drive meaningful decisions.

Studies may be single or multi-modal and may combine multiple isotopes or contrast mechanisms. When designing any study, we combine imaging theory, published methods, and the technical and professional expertise of our staff.

VivoQuant™ is a DICOM compliant post-processing suite for image data combining fundamental viewing functionality with powerful analysis capabilities. VivoQuant (“VQ”) supports data from most imaging modalities including MR, PET, SPECT, CT, and Optical. Multiple display modes including orthogonal views, slice views, special co-registration multi-views as well as 3D MIPs and volume renderings allow users to optimally view information of interest. Built-in features allow imaging scientists to extract the information they need with minimal effort, including powerful tools for fine-tuning images and isolating, drawing and analyzing 3D regions of interest. VivoQuant’s integration with iPACS, a full image study data management platform, offers sophisticated data management, reporting and data sharing tools of VivoQuant-generated data.

Our diverse team of experts has experience in instrument engineering, signal processing, and pharmaceutical R&D; collectively resulting in a long history designing and executing in imaging studies. Our scientists have run hundreds of imaging studies across multiple therapeutic research areas – oncology, neuroscience, inflammation, cardiovascular, metabolic, and musculoskeletal – and our experience runs the gamut of applications. We understand the physiological and biochemical mechanisms that affect imaging – targets, models, kinetics, etc. This vast experience allows us to understand drug behavior and translate knowledge to effective studies and useful data.

We define imaging as assays that enable visualization of subcellular distribution and processes all the way to translational and diagnostic clinical imaging biomarkers – and everything in between. With all imaging techniques, we use methods to ensure data is quantifiable, and leverage our powerful analytics platform to ensure that results can be used to drive meaningful decisions.

Studies may be single or multi-modal and may combine multiple isotopes or contrast mechanisms. When designing any study, we combine imaging theory, published methods, and the technical and professional expertise of our staff.

Our diverse team of experts has experience in instrument engineering, signal processing, and pharmaceutical R&D; collectively resulting in a long history designing and executing in imaging studies. Our scientists have run hundreds of imaging studies across multiple therapeutic research areas – oncology, neuroscience, inflammation, cardiovascular, metabolic, and musculoskeletal – and our experience runs the gamut of applications. We understand the physiological and biochemical mechanisms that affect imaging – targets, models, kinetics, etc. This vast experience allows us to understand drug behavior and translate knowledge to effective studies and useful data.

We define imaging as assays that enable visualization of subcellular distribution and processes all the way to translational and diagnostic clinical imaging biomarkers – and everything in between. With all imaging techniques, we use methods to ensure data is quantifiable, and leverage our powerful analytics platform to ensure that results can be used to drive meaningful decisions.

Studies may be single or multi-modal and may combine multiple isotopes or contrast mechanisms. When designing any study, we combine imaging theory, published methods, and the technical and professional expertise of our staff.

As of February 2016, inviCRO has purchased MNI (Molecular Neuroimaging), a recognized leader in neurological-focused imaging and drug development. Now, with the exciting expansion of capabilities, inviCRO can provide a wide array of clinical imaging services through MNI as a division of inviCRO.

The research scientists and physicians at MNI have a unique capability in radioligand development and use of radioligands to establish target engagement in early clinical trials. We are proud to support the work of their internationally recognized team, and will together develop and execute large-scale clinical imaging trials for diagnosis, progression, and disease monitoring to support radiopharmaceutical and Phase 2-3 pharmaceutical development.

Pharmacology & Toxicology Services

Protein Services

Protein Expression Visualization Services

Immunostaining Services

Bioanalysis Services

Data Analysis Services

Statistical Analysis Services

Biostatistics & Bioinformatics Services

Nucleic Acid Services

DNA Services

ADME/DMPK Studies Services

Pharmacology Services