Emerging Molecular Diagnostics

 

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CHI's Emerging Molecular Diagnostic Partnering Forum is designed to provide a showcase for promising young companies developing novel technologies and solutions for a range of diagnostic applications.  Approximately 40 presenting companies will be selected from proposals being submitted and reviewed by the organizer and by Program Advisors.  A preliminary list of Program Advisors is provided below, many of whom will be participating in panel discussions and engaging in partnering discussions with company presenters during the event.

Company presentations will be segmented into focused sessions over Feb. 11 and 12.  Companies primarily developing integrated diagnostic systems, point-of-care diagnostics, diagnostics for infectious diseases and a range of other indications will present on the first day.  The second day will be devoted to companies primarily developing biomarkers and diagnostics for cancer.  Sessions will be devoted to circulating tumor cells, prognostic tests and cancer companion diagnostics.

A wide range of technology approaches will be represented by presenting companies, including sequence-based diagnostics, multiple gene and protein signatures, multiplexed and digital PCR, microfluidic systems and novel signal detection approaches.  Companies interested in being considered for a company presentation should visit the forum website to submit a proposal: www.triconference.com.  Proposals are being reviewed on a rolling basis.  Please note that there is no presentation fee for accepted proposals.

The feedback from presenting companies and from attendees representing more established pharmaceutical, diagnostic and technology companies that have attended the Molecular Diagnostic Partnering forum has been quite positive.  Unlike other partnering events where there is a wide range of topics for presenters and audience alike, this focused Partnering Forum means that there is likely to be value in networking and collaboration discussions with essentially everyone attending.  CHI's PartnerDirect software is used to facilitate the setting up of partnering discussions prior to, during and after the conference in order to help you get the most value from your participation.  Updates with the list of presenting companies confirmed for the Partnering Forum will be made regularly at www.triconference.com.

 

Program Advisors:  

Steven Anderson, CSO & Vice President, LabCorp 

Brian Atwood, MBA, Managing Director, Versant Ventures 

John Beeler, Ph.D., Director, Business Development, Theranostics, BioMerieux 

Luigi Catanzariti, Ph.D., GPD Executive Director, Novartis Molecular Diagnostics LLC 

Nicholas Conti, Ph.D., Vice President, Business Development, Quest 

Maureen Cronin, Ph.D., Consultant  

Kevin Ellison, Director, Business Development, Almac Diagnostics 

Harry Glorikian, Managing Partner, Scientia Advisors 

Richard Heichemer, Director, Business Development, Quest Diagnostics 

Eric Lai, Ph.D., Senior Vice President & Head, Pharmacogenomics, Takeda Pharmaceuticals International 

Andrea Lauber, Ph.D., Global Head, Transactions for Clinical Biomarkers & Pharmacodiagnostics, Bristol Myers Squibb 

Anh Van Le, Director, Franchise Development, Ortho Clinical Diagnostics 

Jorge Leon, Ph.D., President & CEO, Leomics Consulting 

Thomas Li, Ph.D., Senior Director, Technology Management & Chief Technology Officer, Roche Diagnostics 

Robert Lipshutz, Ph.D., Chief Business Officer & Senior Vice President, Strategic Partnerships, Institute for Systems Biology 

Stephen Little, Ph.D., Vice President, Personalized Healthcare, QIAGEN 

John Meduri, Global Director, Strategic Planning & Business Development, Becton Dickinson 

Iain Miller, Ph.D., Global Head, Personalized Healthcare Strategy & Partnerships, GE Healthcare 

Avi Pelossof, Vice President, Infectious Disease, Alere North America, Inc. 

Frederick Pla, Ph.D., Vice President, Corporate Business Development, Life Technologies 

Cecilia Schott, Ph.D., Director, Business Development, AstraZeneca 

Robert Schueren, Vice President & General Manager, Genomics, Agilent 

Premal Shah, Ph.D., Director, Business Development, Genomic Health 

Morten Sogaard, Executive Director, Head, Biotechnology & Precision Medicine, External R&D Innovation 

Ali Tinazli, Ph.D., Director, Business Development & Sales, Biosciences North America 

Katherine Tynan, Ph.D., President, CellScape 

Emily Winn-Deen, Ph.D., President, Rx DX Advisors, Inc. 

CHI's Second Annual Molecular Diagnostic Partnering Forum  

February 11-12, 2013 | San Francisco, CA


Monday, February 11  

8:00 am Registration and Morning Coffee

9:00 Chairperson's Opening Remarks
Phillips Kuhl, President, Cambridge Healthtech Institute  

9:10 PANEL DISCUSSION: Perspectives on Company Collaboration Interests  

DIAGNOSTIC SYSTEMS  

9:40 Innovative, Rapid, Easy to Use, High Multiplex, Diagnostic and Research Systems to Enable Personalized Medicine
Koen van Acker, Principal Scientist, Biocartis NV

Biocartis is currently in the late stages of development of two cutting edge molecular diagnostic systems for personalized medicine that are unsurpassed in ease of use, speed, sample and assay versatility, and automation. The first is a high multiplex system that allows rapid and simultaneous detection of protein and nucleic acid markers in a dynamic and unique way using binary coded µ-particles. The second is a sample-in to results-out system that enables the simultaneous detection of multiple nucleic acid (DNA and RNA) biomarkers with minimal user intervention from a variety of patient sample types – including formalin-fixed, paraffin-embedded tissue (FFPE). These two systems can be used in a complementary way, as assays can be rapidly developed and validated on one system and ported to the other for clinical diagnostics.

9:55 A Unique MDx Platform and Novel Partnering Strategy for High-Value MDx Development of Molecular Diagnostic and Companion Diagnostic Tests
David Jackson, Vice President, Business Development, PrimeraDxThe ICEPlex System is a unique molecular diagnostic platform that can perform multiplexed, quantitative and multimodal analyses of gene copy number, SNPs/mutations, and expression profiles. This system allows for modular test development from bench assay through IVD development with limited need to repeat studies during development stages. Using this system, PrimeraDx has also established a modular model that streamlines co-development for diagnostic and pharmaceutical partners.

10:10 Enabling the Effective Use of Massive Parallel Sequencing in Clinical Diagnostics
Dirk Pollet, Ph.D., CEO, Multiplicom N.V.
Multiplicom is developing test kits for multiplex PCR-based sample preparation in front of massive parallel sequencing (MPS). We have developed and are commercializing more than a dozen genomic as well as somatic mutation kits that can be used in combination any of the major MPS systems. The first kits have been CE/IVD approved, while others are in the validation phase.

10:25 iCubate 2.0: A Patented Multiplex PCR Technology with an Award-Winning Platform, Open to the World
Jian Han, Ph.D., President and CSO, iCubate, Inc.
iCubate has developed the arm-PCR (amplicon rescued multiplex PCR), a fully integrated system that performs DNA/ RNA extraction, amplification and detection, multiplexed, automated, and in a closed cassette. We integrated arm-PCR and PPI (polymerase preference index) algorithm into a software that is free to developers.

10:40 Fully Automated Sample Preparation and PCR Real Time Detection into a Small Cost Effective Cartridge for Molecular Diagnostic at Point-of-Care
Patrice Allibert, Ph.D., CEO, GenePOC
GenePOC has developed a very simple disposable and an integrated portable stand alone instrument for the prevention and early detection of infectious diseases based on a unique centripetal technology platform. This will enable the availability of cost-effective and rapid molecular devices to detect genes at the point of care.

10:55 Networking Coffee Break  

TECHNOLOGIES  

11:15 Accelerating Development of Highly Sensitive Diagnostics Using in silico Powered Design
Maurice Exner, Ph.D., Vice President, R&D, IntelligentMDx
The drive toward full automation of molecular devices makes it critical to ensure that new tests generate results that provide physicians with the utmost confidence. We have created a unique, proprietary bioinformatics platform, NGENix™, which uses streamlined in silico modeling to design and develop qualitative and quantitative multiplexed, real-time PCR diagnostic tests. Implementing a module-based design, NGENix systematically models all essential factors for optimal assay performance, including selection of a functionally diagnostic gene target, target conservation, calculation of melting temperatures, potential cross reactivity with other genomes, and sensitivity. NGENix-designed assays can be transferred onto any diagnostic instrument platform that utilizes DNA or RNA as the input sample. When coupled with automated instrumentation, these in silico-designed, clinically relevant tests provide enhanced results and faster turnaround times than traditional methods.

11:30 Development of Simple, Cost-Effective Isothermal Molecular Diagnostic Assays for Point-of-Care or Near-Patient Settings
Huimin Kong, Ph.D., President & CEO, BioHelix Corp.
BioHelix develops and commercializes simple and cost-effective molecular diagnostic tests based on its proprietary HDA isothermal amplification technology. The company's first IVD test, the IsoAmp® HSV Assay, utilizes HDA to amplify an HSV-specific sequence followed by detection with a disposable vertical-flow cassette. BioHelix is developing additional IsoAmp® assays including for malaria, group A strep, and HIV. In addition, new development on an automated fluorescence analyzer will be presented.

11:45 A Complementary Set of Molecular Tools Simplifies Multiplexed Analysis of Gene Structure and Expression
Alison Todd, Ph.D., CSO, General Manager & Founder, SpeeDx Pty. Ltd.
SpeeDx has invented a series of proprietary tools for simplified multiplex analysis of gene structure and/or expression, the first of which has been commercialized by Illumina as "NuPCR". Our technology suite forms the basis for a range of clinical tests which are being developed in-house, and in partnership with platform developers. SpeeDx's methodology incorporates multiple universal signal outputs, adaptable to any target gene(s), which can be used in conjunction with a range of platforms for qPCR and/or "point-of-care".

12:00 pm Aptamer-Based Diagnostic Devices
Gregory Penner, Ph.D., President & CEO, NeoVentures Biotechnology, Inc.
After years of promise aptamers have finally come of age for diagnostic applications. Advantages of aptamers over antibodies include cost of production, specificity for targets, and simplicity of use. Disadvantages include lower binding affinities, and a higher cost for identification. We will discuss these strengths and weaknesses, in particular to how this applies to commercial diagnostic applications.

12:15 Flow Chemistry Process Biocompatible Inorganic High Quantum Yield Tetrapod Quantum Dots for the Next Generation of Diagnostic Assays, Multiplexed Drug Delivery Platforms and POC Devices
Stephen B. Squires, President, Quantum Materials Corporation
For the first time, a reliable source exists that can cost-effectively supply any quantity needed of uniform and high quality quantum dots. For one simple example, High Quantum Yield Inorganic Tetrapod Quantum Dots as a BRET acceptor for identifying and imaging targets offer increased accuracy and sensitivity, near-instantaneous processing speeds and advantages in high luminescence, multiplexing, large Stokes shift, narrow wavelength, photostability, in vitro and in vivo imaging, and biocompatibility.

12:30 Barcode All Your Biomarkers with 4,096-Plex Digital Beads
Winston Ho, Ph.D., President, Applied BioCode, Inc.
Barcoded Magnetic Bead (BMB) is a next generation digital multiplexing technology enabling simultaneous molecular diagnostics of up to 4,096 tests from a single sample or a single 96-well. The optical image-based analyzer is robust, easy to operate, and no flow cytometer is involved. BMB tagged with proteins or nucleic acids will enable high plex Biomarker Discovery to rapidly be ported into a lower plex IVD assay.

12:45 Spinning Disk Platform for Digital PCR
Bruce Gale, Ph.D., Department of Mechanical Engineering, University of Utah and Espira, Inc.
Digital PCR provides an absolute quantification method for nucleic acid template and has the potential to improve limits of detection, using either dilution or volume to limit the template per reaction for detection of minor fractions of mutated DNA. Microfluidic approaches have made this technique viable by creating thousands of individual reactions while minimizing reagent consumption. Our proposed platform consists of a plastic microfluidic disk disposable that passively compartmentalizes a sample into thousands of nanoliter-sized wells, a rapid air thermocycler, and a fluorescent scanner to detect the binary 'on/off' digital PCR signal.

1:00 Networking Lunch and Breakout Discussions with Morning Company Presenters 

2:00 Chairperson's Remarks 

2:05 PANEL DISCUSSION: Opportunities and Challenges for Sequence-Based Diagnostics

INFECTIOUS DISEASE  

2:35 Unyvero LRT - Moving a Highly Multiplexed Infectious Disease Test Cartridge for Lower Respiratory Tract Application through the Clinic Towards an FDA Clearance

Johannes Bacher, Chief Operating Officer, Curetis AG

 

2:50 Multiplex qPCR Detection of Drug Resistance Mutations
Eugene Spier, Ph.D., Founder & President, UniTaq Bio

 

3:05 Rapid, On-Demand Infectious Disease Diagnosis
Shana Kelley, Ph.D., Chief Technology Officer, Xagenic, Inc.
We are commercializing a simple and fully automated technology platform that will enable widespread decentralized diagnostic testing to be performed outside of clinical laboratories. Our team is developing infectious disease tests that will allow the detection of a variety of analytes in situations where rapid test turnaround will provide clinically actionable results.

3:20 Beyond the SCCmec Assay: Identifying and Differentiating Staphylococcus Strains in Clinical Specimens for Colonization Screening and Diagnostics
Todd Snowden, President & CEO, PathoGene, LLC
PCR detection of methicillin-resistant Staphylococcus aureus (MRSA) in clinical specimens is being shown to be increasingly less accurate due to: mutations, novel SCCmec types and cassettes missing the mecA gene. Additionally, coagulase-negative Staphylococcus (CNS) is being recognized as an important and common pathogen, up to 60%, in nosocomial methicillin-resistant Staphylococcus infections particularly those associated with increasingly common medical devices. To address these important clinical issues, we developed a triplex PCR assay combined with a novel analysis method that indentifies and differentiates MRSA, MSSA, MSCNS and MRCNS directly from clinical specimens.

3:35 Rapid Detection of Antibody Resistance: Novel Application of Mass Spectrometry in Clinical Microbiology Labs
Alidad Mireskandari, Ph.D., President & CEO, MZ Diagnostics 

3:45 Networking Refreshment Break 

NEXT GEN SEQUENCING AND OTHER INDICATIONS  

4:15 Introducing Cell-Seq™: Massively Parallel Single-Cell Genomics
Andro Hsu, Ph.D., Vice President, Products, GigaGen, Inc.
GigaGen's Cell-Seq™ technology is like RNA-Seq for single cells, with the throughput of flow cytometry. It is the only technology capable of measuring identity, abundance, and function of single immune cells with high sensitivity and throughput--all without the need for antibody staining or cell sorting. By monitoring the cells directly responsible for transplant rejection, autoimmune disease, Cell-Seq™ identifies and tracks highly personalized, private biomarkers of a person's immune response.

4:30 Applications of Immune Cell Profiling by Next-Generation Sequencing
Malek Faham, M.D., Ph.D., Chief Scientific Officer, Sequenta, Inc.
Sequenta has leveraged the advances in next generation sequencing to comprehensively sequence the immune repertoire. Combined with Sequenta's specialized bioinformatics , we have developed a diagnostic test, offered in our CLIA lab, to measure and monitor minimal residual disease (MRD) in hematological cancers, with far greater sensitivity and specificity than traditional methods. Furthermore, Sequenta has developed methods for measuring biomarkers of immune response (i.e. vaccines) and autoimmune disease.

4:45 RNA Sequencing of Blood for Early Diagnosis of Autism
Stanley Lapidus, President, SynapDx Corp.
Autism and developmental delays affect 1:10 children. Autism itself represents 10% of this total. Autism outcomes are best when the disorder is diagnosed early. Today the diagnostic journey is long, averaging over two years in the US. By offering a test which helps distinguish autism from developmental delay, we expect to shorten the time to diagnose autism and to accelerate the start of behavioral therapy.

5:00 Discovery and Application of an Epigenomic Signature to Generate a Revolutionary New Molecular Diagnostic and to Identify Novel Therapeutic Targets in RA and Other Autoimmune Diseases
Jonathan Lim, Ph.D., CEO, IGNYTA, Inc.
IGNYTA employs advanced, proprietary epigenomic technologies to identify robust epigenetic signatures that distinguish rheumatoid arthritis (RA), osteoarthritis (OA), systemic lupus erythematosus (SLE) and other autoimmune diseases from each other in patients. Development of such signatures can lead to more accurate and efficient molecular diagnostics that guide patient care and can help physicians provide customized therapeutic regimens for their patients. Additionally, such signatures hold promise to identify novel biological targets for therapeutic intervention.

5:15 Development of Salivary Oligosaccharide Diagnostic Assays for Monitoring Risk of Intestinal Inflammatory Conditions
Ardythe L. Morrow, Ph.D., Cincinnati Children's Hospital Medical Center & Glycosyn, LLC
Medical diagnostics of intestinal conditions typically involve relatively invasive methods that are not useful for ongoing patient monitoring, or collection of stool samples, which is cumbersome and awkward. Glycosyn LLC. develops and commercializes oligosaccharides that have broad implications for intestinal health, and has licensed the patents on novel salivary oligosaccharide phenotyping for monitoring patient risk of intestinal inflammatory conditions. In this presentation we review the opportunity to use salivary markers that predict risk of necrotizing enterocolitis in preterm infants and provide means of monitoring the status of intestinal inflammation among patients under treatment for inflammatory bowel disease.

5:30 Highly Sensitive & Specific Serum Test for Preeclampsia
Matthew Cooper, CEO, Carmenta Bioscience

 

5:45 Networking Break and Breakout Discussions with Afternoon Company Presenters 

6:30 Close of Day 

Tuesday, February 12 

CANCER DIAGNOSTICS  

8:15 am Morning Coffee 

8:45 Chairperson's Remarks 

8:50 PANEL DISCUSSION: Trends and Prospects for Cancer Biomarkers 

CIRCULATING TUMOR CELL APPROACHES  

9:20 Applications of a Liquid Biopsy Platform for Next-Generation Sequencing of CTC Populations
Paul Dempsey, Ph.D., Vice President, Bioengineering, Cynvenio Biosystems, Inc.
Circulating Tumor Cells (CTC), a critical component of metastatic dissemination of tumors, have been enumerated and well characterized morphologically. We have developed a platform and supporting protocols for sequence analysis of SNP within the CTC population. This platform has utility in tumor monitoring especially in patients with difficult to biopsy disease.

9:35 Precision Microfilters Enable Rapid and Efficient Collection Followed by Sophisticated Analysis of Circulating Tumor Cells
Cha-Mei Tang, Sc.D., President and CEO, Creatv MicroTech, Inc.
Various methods have been developed to isolate CTCs from patient peripheral blood, including immunocapture, microfluidic chips, and size exclusion filtration. Of these methods, filtration has demonstrated utility for the largest number of tumors and the widest range of CTC analysis methods. Creatv's CellSieveTM microfilters have high porosity and precise pore size and distribution, providing reliable, high capture efficiency with low leukocyte contamination. Processing is rapid - 3 minutes - allowing capture of live cells, and the work flow is simple. The filter membrane is optically clear, which enables detailed morphological examination of the individual cells. The CTCs can be used for enumeration, IHC, PCR, FISH, RNA ISH, sequencing, and culture. CellSieveTM microfilters are now in research use for carcinomas.

9:50 Rarecells: Early and Reliable Cancer and Prenatal Diagnosis on Simple Blood Tests
Patrizia Paterlini Brechot, Professor of Cell Biology and Oncology, University Paris Descartes and Rarecells
ISET: "Isolation by Size of Epithelial Tumor and Trophoblastic cells" by Rarecells allows for early diagnosis and real time follow-up of all types of cancer; non-invasive theranostic tests ("liquid biopsy" ) for personalized, targeted treatment; and early and non-invasive prenatal diagnosis of all genetic diseases (avoiding risk of miscarriage).

10:05 Molecular Analysis of Circulating Tumor Cell Samples for Oncology Diagnostics Using the IsoFlux Rare Cell Access System
Michael Schwartz, Program Director, Business Development, Fluxion Biosystems, Inc.
Many of the initial approaches to CTC isolation have focused on capturing cells on a slide or substrate for further image-based analysis. Recovering these cells for subsequent molecular analyses poses numerous challenges to maintain the purity, viability, and concentration of the sample. The IsoFlux System was developed specifically to move CTCs and other rare cells directly into downstream molecular assays with high capture efficiency, viability, and cellular concentration (<20µL per sample).

10:20 Cell Adhesion Matrix-Based Isolation of Invasive Circulating Tumor Cells – iCTCs
Casey Eitner, Senior Vice President, Business Development, Vitatex, Inc.
Vitatex's unique advantage stems for its ability to isolate invasive CTCs, or iCTCs, directly linked to the metastatic process. Our technology harnesses the very mechanism by which metastatic cells invade surrounding tissue and spread throughout the body – the attachment to and ingestion of cell adhesion matrix (CAM) proteins. Vitatex's proprietary CAM surface coating captures viable iCTCs from standard Vacutainer-drawn blood samples that can readily be cultured in the presence of cancer drugs to optimize patient-specific treatment selection. CAM-capture results in a higher, more robust yield of iCTCs for analysis by automated flow cytometry to provide an early indication of metastasis and to monitor treatment. Vitatex assays also have significant applications in development and testing of new cancer drugs, and metastasis models and markers developed with iCTCs provide fundamental new tools to study cancer spread and discover new treatment approaches.

10:35 CEE-Selector™, a Molecular Diagnostic Assay with Unprecedented Sensitivity and Utility which is Applicable to a Wide Range of Sample Types

Lyle Arnold, Ph.D., CSO and Senior Vice President, R&D, Biocept Laboratories

We have developed high sensitivity molecular diagnostic assays with unprecedented sensitivity and utility. These assays were initially developed to detect cancer associated mutations within circulating tumor cells when present in complex genomic backgrounds. These assays have proven however to be applicable to a wide range of sample types including total nucleic acid from plasma. Two different versions of the Selector Assay have been developed and both versions can detect either single mutations or groups of mutations depending upon assay design. Both versions can detect single nucleotide variations (SVNs) down to single copies, in complex genomic backgrounds with sensitivity of >1:10,000. Additionally, these assays are quantitative, and work with qPCR, end-point PCR, digital PCR, and melt-curve analysis. They also interface readily to sequencing platforms, mass-spec, capillary separation, and array technologies, where the selective amplification of specific target regions allows for the interrogation of rare genetic events.

10:50 Networking Coffee Break

 

PROTEIN AND TISSUE CANCER BIOMARKERS  

11:10 Structural Biomarkers in Cancer Diagnostics: Technology and Case Studies
Arnon Chait, Ph.D., President, AnalizaDx, LLC
We developed a first-in-class technology platform for rapid low-cost determination of structural changes to protein biomarkers. The technology is applicable to a range of cancers, and is executed using conventional med lab instrumentation. We demonstrate clinical performance of structural biomarkers for prostate, breast, and ovarian cancers, using a range of detection technologies, including ELISA, multiplexed assays, and mass spectrometry.

11:25 Exploiting the Body's Own Detection Network for Reliable Diagnostics of Cancer and Autoimmune Diseases
Mats Grahn, CEO, Immunovia ABImmunovia's founders, working within a well-funded environment and in partnership with practicing clinicians and industry, have perfected a sensitive, reproducible and scalable antibody microarray platform, as well as "GPS" (Global Proteome Survey), an additional novel Discovery tool capable of screening deep into the proteome. The three most advanced tests based on this platform have been clinically tested and shown unprecedented levels of sensitivity and specificity and are based on minimally invasive blood tests: the first high confidence detection/confirmation of pancreatic cancer, including the ability to distinguish cancer from different inflammations, as well as opportunities to screen high risk groups for early detection, significantly increasing survival rates; screening for the risk of recurrence in breast cancer patients, avoiding under & over treatment after surgery, and subsequent monitoring of disease, at a time when the clinicians are lacking accurate diagnostic tools but when a change in treatment regime would benefit the patient; and high-confidence diagnosis, classification and flare prognosis of Lupus (SLE), a milestone achievement in accurately defining autoimmune disease status, enabling correct and timely treatment.

11:40 Live Tumor Testing with the SnapPath™ System Enables Next-Generation, Predictive Diagnostics
Adam Schayowitz, Ph.D., Senior Director, Operations and Business Development, BioMarker Strategies
BioMarker Strategies is developing a live, solid tumor testing system to enable next-generation predictive tests for cancer. The SnapPath™ system combines automated live-cell tissue processing with pathway-based ex vivo biomarker tests to improve drug development and predict patient response to targeted cancer therapeutics. By modulating a patient's tumor sample outside of their body, SnapPath™ generates phosphoprotein-based Functional Signaling Profiles (FSPs) that reveal information about the signal transduction networks, pathway activation, and feedback loops within the tumor cells. SnapPath™ moves beyond traditional genomic profiling of fixed tissue to enable a new level of stratification and profiling of cancer patients.

11:55  Tissue Based  Diagnostics for Oncology

Mike Hoerres, CEO, Cernostics

Most current diagnostic approaches offer a limited view of cancer because they fail to evaluate the tumor as a system composed of multiple cell types, not merely tumor cells.  Cernostics’ molecular diagnostic classifiers integrate multiple data types including tissue morphology, quantitative biomarker data, and patient outcome data from EHR information to produce clinically actionable information including risk of recurrence, therapy response and accurate diagnosis of tissues graded as indeterminate by traditional pathology methods.  Cernostics’ patented technology is based on a systems approach to evaluating tissues via anatomic pathology, and simultaneously evaluates immune, stromal, stem cell and tumor biomarkers on a single slide while also preserving tissue structure.

 

12:10 Networking Lunch and Breakout Discussions with Morning Company Presenters 

1:25 Chairperson's Remarks 

1:35 PANEL DISCUSSION: Commercialization Considerations for Molecular Diagnostics 

GENE MUTATION, EPIGENETIC AND GENE EXPRESSION BIOMARKERS FOR CANCER  

2:00 Transrenal Based Molecular Diagnostics - The New Paradigm
Michael Terry, Vice President, Corporate Development, Trovagene, Inc. 

2:15 Personal Genome Diagnostics - Next-Generation Approaches to Cancer Research and Diagnostics
Antony Newton, Chief Commercial Officer, Personal Genome Diagnostics
Personal Genome Diagnostics has developed proprietary techniques that identify mutations found in a patient's tumor in order to characterize unique aspects of each patient's disease. We have a strong R&D program, are involved in multiple research collaborations and have moved rapidly to CLIA certification for diagnostics.

2:30 Quantitative and Sensitive Bisulfite-Free DNA Methylation Profiling from FFPE Tissues: A New 8-Gene Clinical Test for Brain Cancer Prognostics
Michelle Hanna, Ph.D., CEO & Scientific Director, Diagnostics, RiboMed Biotechnologies
A novel, bisulfite-free technology for the quantitative analysis of DNA Methylation biomarker panels, even in compromised Formalin Fixed Paraffin Embedded (FFPE) tissues, is presented. The methylation levels of up to 25 genes can be quantitatively determined with as little as 10 nanograms of DNA. The use of Mass Spectrometry generates a percentage methylation level for each gene and these data are combined to determine the CpG Island Methylator Phenotype (CIMP) status for the tumor, a prognostic indicator.

2:45 The Role of Methylarginine Biomarkers in 21st Century Personalized Medicine
John Aletta, Ph.D., Principle Scientist, CH3 Biosystems LLC
Protein arginine methylation, in the 20th century considered a trivial structural co-translational event, is now acknowledged to be a much more dynamic chemical regulator. The number of proteins known to exhibit methylarginine marks has increased from a handful to hundreds. Many are currently viewed as druggable targets for cancer and other diseases. This presentation outlines data suggesting that methylarginine marks on proteins represent important biomarkers for R&D and, ultimately, diagnostics and drug targeting. CH3 BioSystems and its academic partners are exploring the usefulness of methylarginine detection to stratify the molecular pathologies evident in human tumors based on protein methylation status.

3:00 GeneCentric Diagnostics: Developing Novel Personalized Cancer Diagnostics
Myla Lai-Goldman, Ph.D., CEO, GeneCentric Diagnostics, Inc.
The mission of GeneCentric is to develop and commercialize novel molecular diagnostic assays that enable oncologists and their patients make more informed, individualized treatment decisions. GeneCentric's portfolio includes two unique platform technologies. The Lung Subtype Platform (LSP) holds promise for stratifying lung cancer patients, while the Hypoxia Signature Platform has the potential to identify patients that respond to anti-angiogenesis therapies. GeneCentric utilizes a unique partnership model to translate important cancer discoveries into clinically adopted diagnostics for pathologists, clinicians and patients.

3:15 Networking Refreshment Break

 

4:35 BronchoGen: A New Genomic Test for Lung Cancer
Michael Webb, CEO, Allegro Diagnostics, Inc.
BronchoGen is a recently released laboratory-developed genomic test for aiding in the diagnosis of Lung Cancer. It is intended for use in the more than 150,000 patients per year in the United States who receive a bronchoscopy that yields equivocal or non-diagnostic results for malignancy. Bronchoscopy has historically seen frustratingly finite diagnostic yield do to the anatomic challenges of the lung: BronchoGen fits neatly into the standard diagnostic workup and provides an accurate rule-out of malignancy on the basis of gene expression in histologically normal epithelial cells of the upper airway. It has the potential to greatly increase the efficiency of lung cancer diagnosis and reduce the need for many invasive diagnostic procedures. Allegro plans to use its gene expression technology to develop a non-invasive screening test and to discover potential drug targets in early cancerization pathways.

3:50 Oncimmune's EarlyCDT®-Lung Blood Test Demonstrates Utility as a Lung Cancer Risk Assessment Tool for High-Risk Patients as well as a Lung Cancer Risk Stratification Tool for Patients with a Pulmonary Nodule
John Robertson, Ph.D., CSO & Co-Founder, Oncimmune
Oncimmune's EarlyCDT®-Lung blood test for early lung cancer detection in high-risk individuals has two distinct utilities: 1) as a risk-assessment tool to aid evaluation of the probability of lung cancer in i) a patient within the population criteria evaluated by the National Lung Cancer Screening Trial (NLST) as well as ii) populations which fell just outside the NLST criteria, and 2) as a risk stratification tool for patients already diagnosed with a lung nodule. Launched in May 2009 as a 2-strata test, EarlyCDT-Lung has shown to be highly robust and reproducible, both in case-control validation studies as well as in an audit of clinical outcomes; a positive EarlyCDT-Lung result indicates a 5-6X increase in risk of lung cancer. Recent developments have demonstrated that modifying EarlyCDT-Lung to a 4-strata test (i.e., – low negative, negative, positive and high positive) could further increase the risk stratification potential of EarlyCDT-Lung with a high positive having a >25X increase in risk of lung cancer compared to a low negative. In patients already diagnosed with a pulmonary nodule, a positive EarlyCDT-Lung result using the current two strata test showed, on average, a 3.5X increase in lung cancer risk.

4:05 Discovery, Development and Commercialization of Genomics-Based Oncology Diagnostics
David Craford, Chief Commercial Officer, Pathwork Diagnostics, Inc.
Pathwork discovers, develops, and commercializes complex signature based diagnostics. Pathwork has two FDA cleared molecular classification tests and collaborations to discover and develop biomarkers with leading Pharma in oncology. Pathwork is expert at launching, developing the market, and gaining reimbursement for high value tests in Oncology.

4:20 Clinical Relevant Biomarkers for Data Driven Decision

Harry Pan, Ph.D., CEO, Renascions Corp.

 

4:35 Discover Novel Biomarkers Using Archived Clinical Samples Retrospectively by Genomewide Scan

Wen Luo, Ph.D., CSO, Denovo Biomarkers

4:50 Networking Reception and Breakout Discussions with Afternoon Company Presenters

 

5:40 End of Partnering Forum 

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