Session Abstract – PMWC 2022 Silicon Valley


The PMWC 2022 Data Applications in Clinical Diagnostics Showcase will provide a 15-minute time slot for selected organizations, including commercial companies, clinical testing labs, and medical research institutions, to present their latest advancements, insights, applications, and technologies to an audience of clinicians, leading investigators, academic institutions, pharma and biotech, investors, and potential clients. We will learn about new technologies and findings that promise expedited, cost-effective, and accurate clinical diagnosis for early disease detection, treatment decisions, and disease prevention.

- Clinical Dx/Oncology (including Liquid Biopsy)
- Clinical Dx/Cardio Vascular
- Clinical Dx/Nerodegenerative


Confirmed Presenting Companies:

 Session Chair Profile

Ph.D., Chief Scientific Officer, Exosome Diagnostics

Biography
Johan Skog is a renowned, well-published thought leader in exosome science having pioneered breakthrough discoveries about exosomes and other microvesicles and their vital role as cell messengers and disease proliferators. While at Massachusetts General Hospital/Harvard Medical School, Dr. Skog discovered that tumor-derived mutations can be detected in exosome RNA from serum and other biofluids, findings which were published in Nature Cell Biology in 2008. Additionally, he demonstrated that exosomes serve to deliver messages to other cells, inducing changes favorable to the proliferation of cancer. At Exosome Diagnostics, Dr. Skog continues to pioneer critical advancements in diagnostics and expand the field of exosome biology. Dr. Skog’s research background includes virology, gene therapy, brain tumors, RNA and biomarker discovery, and he is an inventor on several patents. Dr. Skog earned his Master of Biomedical Sciences and Doctorate at Umeå University, Sweden.

Talk
The Advantages of Exosomes (EV’s) as a Liquid Biopsy Based Marker


Clinical Dx Showcase:
Exosome Diagnostics

Exosome Diagnostics, a leader in developing liquid biopsy-based diagnostics, is the first and only company that can simultaneously isolate and analyze exosomal RNA and cfDNA in a single step to achieve highest sensitivity for detecting rare mutations. ExosomeDx empowers the world’s leading biopharma companies in exploring this unique technology.

Exosomes: New Standard In Multi-Analyte Liquid Biopsy Testing

 Speaker Profile

Ph.D., Sr. Director, Oncology R&D, Labcorp Oncology

Biography
After studying in the field of cancer epigenetics, Taylor Jensen, Ph.D. joined Sequenom in 2009 and was part of the team that developed and launched the first commercially available noninvasive prenatal test based on circulating cell-free DNA (cfDNA) in the U.S. Subsequently, Dr. Jensen has been involved in numerous assay development efforts focused on the identification and detection of genetic and epigenetic changes in cfDNA for use in prenatal and cancer diagnostics. Since the acquisition of Sequenom by LabCorp in 2016, his work has been primarily focused on precision medicine assay development and product strategy in oncology with the overarching goal of utilizing innovative technologies to improve human health.


Clinical Dx Showcase:
Labcorp

Through unparalleled diagnostics and drug development capabilities, Labcorp provides insights and accelerate innovations to improve health and improve lives.

Personalized Cancer Care-The Role of Somatic and Germline NGS Test
Cancer is a disease of the genome with aberrations derived from both somatic and germline origins; therefore, a comprehensive genetic assessment of the tumor may be optimal to guide treatment, prognosis, and future risk for a patient and their family.

 Speaker Profile

Ph.D., CEO, Travera

Biography
Clifford Reid is the founding CEO of Travera. Previously, Dr. Reid was the founding Chairman, President and Chief Executive Officer of Complete Genomics (NASDAQ:GNOM), a leading developer of whole human genome DNA sequencing technologies and services. Prior to Complete Genomics he founded two enterprise software companies: Eloquent (NASDAQ:ELOQ), an internet video company, and Verity (NASDAQ:VRTY), an enterprise search engine company. Dr. Reid is on the Visiting Committee of the Biological Engineering Department at the Massachusetts Institute of Technology (MIT), a member of the MIT Corporation Development Committee, and an advisor to Warburg Pincus. He earned a S.B. in Physics from MIT, an MBA from the Harvard Business School, and a Ph.D. in Management Science and Engineering from Stanford University.


Clinical Dx Showcase:
Travera

Travera has developed a new technology for identifying effective cancer drugs and drug combinations for cancer patients. We use a new measurement device invented at MIT to weigh single cells with sub-picogram accuracy, directly measuring the ex vivo response of cancer cells to cancer drugs.

A Universal Cancer Biomarker for Rapid Therapy Guidance
Travera has developed a new technology for identifying effective cancer drugs for cancer patients. We use a new measurement device invented at MIT to weigh single cells with sub-picogram accuracy, directly measuring the ex vivo response of cancer cells to cancer drugs.

 Speaker Profile

Ph.D., CEO, Arvetas Biosciences

Biography
Having dedicated his career to advancing innovative testing tools and treatments for conquering cancer and other debilitating diseases, Alan K. Hauser has 3 decades of experience under his belt encompassing the biotechnical, intellectual property, market, and business aspects of commercializing disruptive drug-discovery and diagnostics platforms, including pioneering microfluidic lab-on-a-chip and DNA microarray systems. With a track record of cross-functional success championing multi-omic Innovation to Commercialization (I2C) by translating promise into practice, Alan has helped launch nine genomic products and build eight bioscience businesses, with company exits exceeding $2 billion. Dr. Hauser’s prior I2C leadership directed toward companion diagnostics (CDx)-stratified precision oncology is particularly relevant as he creates value for Arvetas by charting and executing strategic ROI-led I2C roadmaps and partnering plans for the Company’s proprietary MosaicaTM multiplex spatialomics profiling (MSP) platform. The Arvetas next-generation CDx 2.0 solution holds promise to help oncologists guide treatment decisions by accurately predicting patient response.


Clinical Dx Showcase:
Arvetas Biosciences

Arvetas is a multiomic spatial profiling company developing next-generation MSP-powered companion diagnostics tests, which, unlike existing low-plex tissue biopsy-based assays, hold tremendous promise to accurately predict clinical outcomes by employing a new class of holistic signatures of a large number of mRNA and protein markers.

Predictive Diagnostics Reimagined - Multiomic Spatial Profiling
Arvetas Biosciences is championing a groundbreaking multiomic spatial profiling (MSP) platform, which, unlike other spatialomic technologies, can simultaneously interrogate a large number of biomarkers (mRNA transcripts and proteins) in clinical tissue with only one round of direct staining and imaging.

 Speaker Profile

Ph.D., Director (Clinical R&D), Claret Bioscience

Biography
Dr. Varsha Rao is the Director of Clinical R&D at ClaretBio. She oversees the clinical applications of the novel next-generation sequence assays and analytical pipelines developed at ClaretBio with a main focus on evaluating the utility of cell-free DNA fragmentation patterns in cancer progression and treatment response monitoring. Before joining ClaretBio, she was a Research Scientist at Stanford University School of Medicine in Prof Michael Snyder’s lab. As a part of multiple consortia such as the Integrative Personalized Omics Profiling Project, the Human Microbiome Project and the NASA Twins Study she has worked on longitudinal multiomic analyses, focusing on applying transcriptomics and liquid biopsy approaches to understand nuances of metabolic diseases, cancer, infectious disease and general health. She received her PhD in Molecular and Cellular Biology from University of Maryland Baltimore County in 2012.


Clinical Dx Showcase:
Claret Bioscience

Claret Bioscience’s mission is to improve the quality of NGS data obtained from degraded, highly fragmented, and low yield samples. Our approach aims to provide a complete picture of cfDNA molecules, enhancing the sensitivity of disease screenings, and ultimately improving treatment decisions.

cfDNA Fragmentomic Approach to Precision Oncology
We describe a new approach for cancer disease monitoring that leverages cell-free DNA fragmentation patterns - looking beyond traditional rare somatic mutation detection - with a specific focus on our novel single-stranded library preparation method, SRSLY.

 Speaker Profile

Ph.D., CTO, Genomill Health

Biography
Manu Tamminen is an expert in molecular biology, next- generation DNA sequencing and bioinformatics. He received his PhD from the University of Helsinki and did his post-doctoral research at MIT and ETH Zürich, where he developed methodologies for single cell sequencing and molecular counting. He is currently an Adjunct Professor and Academy Fellow at the University of Turku and has authored several high-impact research publications.


Clinical Dx Showcase:
Genomill Health

Genomill Health is a precision diagnostics company with a technology for extremely scalable, sensitive and cost-efficient liquid biopsies.

Geno1 - Scalable, Sensitive and Cost-efficient Liquid Biopsies
Genomill's Geno1 is an extremely scalable, sensitive and cost-efficient technology for liquid biopsies and beyond. Geno1 is a minimalistic, platform-agnostic NGS-library preparation workflow which takes advantage of unique molecular identifiers and non-exponential signal amplification. Here we present an analytical validation of these features.

 Speaker Profile

President, Trapelo Health

Biography
Clynt Taylor brings over 20 years of experience in healthcare technology innovation, both as an entrepreneur and senior executive with startup and growing companies. He joined Trapelo Health in 2017 as Chief Executive Officer and under his leadership the company developed the company’s signature product, Trapelo, which helps speed access to the most appropriate treatments for cancer patients. Since beginning his career at IBM, he’s held leadership roles at healthcare technology companies like NextGen, where he led sales and marketing teams; HealthVision as General Manager of its fastest growing division (purchased by Lawson) and Galvanon as Co-founder and CEO Healthcare Solutions (purchased by NCR). Most recently, he held various senior executive roles with NantHealth – including leading the innovation, launch and commercialization of eviti, Inc., recognized today as one of the nation’s premier oncology decision support solutions.


Clinical Dx Showcase:
Trapelo Health

Trapelo Health is a health technology company on a mission to address the challenges that result from rapid changes in the science, technology and business of next-generation cancer care. Its product, Trapelo, is a win-win solution for doctors, labs and payers that need real-time, evidence-based information and full transparency to make patient-based decisions faster. As part of this commitment, Trapelo founded The Precision Medicine Podcast.

Collaborative Precision Medicine Platform Accelerates Biomarker Adoption
The lag in biomarker adoption is preventing patients from accessing life-extending precision therapies and trials. Learn about the only collaborative, decision-support platform that aligns oncologists, labs and payers, streamlines ordering and ensures the right biomarkers are tested every time.

 Speaker Profile

PHARM.D., VP, Clinical Strategy and Innovation, Specialty, Magellan Rx Management

Biography
Dr. Haita Makanji joined Magellan Rx Management in 2014. She is the vice president of clinical strategy and innovation within specialty in which she assumes several roles and responsibilities, including development and management of specialty clinical programs and interfacing with payers and pharmaceutical companies to bring industry-leading solutions that curb rising specialty spend. She is responsible for design, implementation, and operations of specialty clinical programs that improve the quality of care for patients with high-cost disease states across several lines of business including employer groups and Medicaid plans. She oversees the Comprehensive Oncology Management Program which encompasses innovative utilization management strategies with complex case management. Additionally, Dr. Makanji leads a team of pharmacists, including board-certified oncology pharmacists who are tasked to support payers and assist with comprehensive medical and pharmacy data analyses, prior authorization and medical policy design, and organizing unique key opinion leader thought leadership panels. 


Clinical Dx Showcase:
Magellan Rx Management

Magellan Rx Management, a division of Magellan Health, Inc., is shaping the future of pharmacy. As a next-generation pharmacy organization, we deliver meaningful solutions to the people we serve.  As pioneers in specialty drug management, industry leaders in Medicaid pharmacy programs and disruptors in pharmacy benefit management, we partner with our customers and members to deliver a best-in-class healthcare experience.

 Speaker Profile

CEO, Pierian

Biography
Mark McDonough is a global technology business executive with 30 years of experience, and he has been CEO of Pierian since November 2020. His personal mission is to impact change in the field of healthcare in a compassionate yet resolute manner, leading by example. Prior to Pierian, Mark has served as President, CEO, and Board member for private companies like Immunis.AI, a pre-commercial liquid biopsy company, where he secured funding and developed a top flight team within six months of hire, and public companies like CombiMatrix, a leader in high complexity reproductive health testing. McDonough served as President, CEO and board member of CombiMatrix from 2012 through 2018, orchestrating its sale to Invitae in November 2017. Under his leadership, CombiMatrix experienced 14 consecutive quarters of record growth. Earlier in his career, he served in various sales leadership roles at high growth diagnostic companies to include Ventana Medical Systems (acquired by Roche) and US LABS (acquired by LabCorp). He is married with three children and is a proud former Naval Officer having served as a Navigator and Communications Officer on the USS FLETCHER (DD 992).


Clinical Dx Showcase:
Pierian

Pierian partners with clinicians and medical facilities to advance clinical genomics and modernize patient care.

Bringing NGS Oncology Testing Closer to Home
Building an onsite precision medicine program provides faster results, improved care, and greater control over samples and data. Pierian guides you through the entire process and provides advanced interpretation technology to identify actionable variants, delivered in a best-in-class genomics report.

 Speaker Profile

Olink Proteomics

Biography
Speaker Olink Proteomics


Clinical Dx Showcase:
Olink

Olink Proteomics Provides innovative solutions for targeted human protein biomarker discovery and development, with rapid, high-throughput immunoassay analysis, exceptional data quality. Disease or biology-focused panels allow simultaneous analysis of 92 of 1,000 biomarkers with 1-15 μl of sample, as fee for service or kits.

 Speaker Profile

M.D., Chief Medical Officer, Digital Health, Invitae

Biography
Dr. Rakesh Patel is a renowned oncologist with a special interest in breast cancer, genomics, and precision medicine. He serves as Chair of the Multi-disciplinary Breast Cancer and High-risk Programs at Good Samaritan Hospital. Dr Patel has given over 250 lectureships around the globe and is a co-founder in a leading nationwide Breast Cancer KOL think tank. He has led multiple healthcare startups focusing on clinical gaps, care coordination, real-world data, and patient engagement. He is a co-founder of Medneon, an AI digital health provider platform for cancer risk assessment and management which was acquired by Invitae in 2021. He now serves as the Chief Medical Officer of Digital Health for Invitae.


Clinical Dx Showcase:
Invitae

Our genes can transform our health. Invitae's mission is to bring genetics to mainstream medicine to improve healthcare for billions.

Clinical Decision Support Tools in Oncology
There is a large amount of genetic information and novel therapies that are now available and keeping providers updated of the rapidly changing guidelines for risk assessment, genetic testing and management can be challenging.

 Speaker Profile

Ph.D., CEO, BillionToOne Inc.

Biography
At BillionToOne, Oguzhan co-developed a molecular counter platform that increases the resolution of cell-free DNA diagnostics by over a thousandfold. This technology was used to develop BillionToOne’s single-gene NIPT, which is the only (and fastest-growing) test that can detect the most common inherited disorders such as sickle cell disease, cystic fibrosis, and spinal muscular atrophy in the fetus directly from maternal blood. Oguzhan led BillionToOne through Y Combinator and raised a total of more than $90M in funding including from venture capital funds and investors who previously invested in companies such as SpaceX, Uber, Box, Spotify, Palantir, Braintree, WebMD, and Omada Health. Previously, Oguzhan received his PhD from Stanford, where his work was published on the Cover of Cell Systems, and graduated summa cum laude and Phi Beta Kappa from Princeton University with a Bachelor’s in Molecular Biology and minors in Physics, Computer Science, and Applied Mathematics.


Clinical Dx Showcase:
BillionToOne Inc.

BillionToOne is a precision diagnostics company with the mission to make molecular diagnostics more powerful, accurate, and accessible for all. Our QCT molecular counting platform enables us to offer unique products from single-gene NIPT to quantitative liquid biopsy for treatment monitoring.

Molecular Counting Enables High-resolution Liquid Biopsy Panel for Cancer Treatment Monitoring
We describe a novel pan-cancer liquid biopsy panel that quantifies the changes in cell-free tumor DNA level at the single-molecule resolution in cancer patients, without the need to customize the panel.

 Speaker Profile

Ph.D., CEO and CSO, C2i Genomics

Biography
Dr. Asaf Zviran brings 15+ years of R&D management in biology and defense.To date he has managed to publish 13 papers with over 1,700 citations (including Nature and Stem Cell). Asaf received multiple awards and grants. He is an IDF R&D Officer (Captain) with a PhD in Molecular Biology.


Clinical Dx Showcase:
C2i Genomics

C2i Genomics is the first company to develop post-surgery monitoring of cancer recurrence and progression by analyzing subtle changes in the pattern of the tumor’s DNA.

C2i’s Cancer Recognition for Personalized Treatment Monitoring
C2i’s SaaS solution utilizes a cloud-based platform to perform cancer tumor burden monitoring on a global scale, leveraging low-input blood (only 2mL blood) whole-genome sequencing to provide high precision personalized medicine, reduced cancer treatment costs, and accelerated drug development.

 Speaker Profile

Ph.D., Sr. Director, Product Development, Invivoscribe

Biography
Dr. Ying Huang has over 25 years of research and industry experience with a broad knowledge in technology and assay development. Ying is passionate about developing novel methods using cutting edge technologies to improve lives with precision diagnostics. Her current work involves applying Invivoscribe assays to MRD detection in hematologic disease samples. Prior to Invivoscribe, she worked at Illumina, Acea Biosciences, Nanogen and MD Anderson Cancer Center. In those roles, she developed a variety of methods ranging from isolating CTC using microfluidic devices to detecting biowarfare agents using electronic microarray. She is co-author of more than 60 publications and abstracts and is co-inventor of 9 patents. Ying received her Ph.D in Electrical Engineering from Bangor University, UK.


Clinical Dx Showcase:
Invivoscribe

Invivoscribe is a global leader in hemato-oncology diagnostics. Our flow & molecular assays, reagents, controls, bioinformatics & services focus on actionable biomarkers supporting therapeutic decisions, MRD testing, stratification & CDx development.

AML MRD Testing Using Flow and NGS
MRD has become an important role as potential diagnostic, prognostics, efficacy-response and monitoring biomarker in AML. Invivoscribe offers complementary AML MRD testing using a comprehensive 12-color flow cytometry assay and a 53-gene NGS panel with limited primary samples.

 Speaker Profile

M.D., Ph.D., Founder and Chairman, Parthen Inc.

Biography
Dr. Leyland-Jones’ principal academic contributions have been in the fields of anticancer therapy development, the pharmacodynamics, pharmacokinetics, and pharmacogenetics of oncological clinical trials, the translation of preclinical models into the clinic, biomarker endpoints in Phase I/II clinical trials, and screening and mechanistic studies of novel targeted and chemotherapeutic anticancer agents. He has authored and co-authored more than 210 peer-reviewed articles and book contributions, 25 books and book chapters, 425 abstracts and 35 patents.


Clinical Dx Showcase:
Parthen Inc.

Parthen has a singular mission – to expand precision medicine to all people regardless of background, income or geographic location. This will be accomplished through a novel, virtual collaboration with front line physicians in communities around the world.

Precision Medicine for All
The time has come to move precision medicine away from current expensive and exclusive practices and into the community setting. Parthen is developing a new approach to lower costs, increase availability and provide a concierge experience to all people.

 Speaker Profile

Ph.D., CEO, Foresight Diagnostics

Biography
Dr. Chabon is a co-founder of Foresight Diagnostics where he is focused on commercializing a novel liquid biopsy testing platform for the measurement of minimal residual disease (MRD) that enables detection of ctDNA at levels as low as one part-per-million. He is a molecular biologist and bioinformatic scientist by training with extensive NGS assay development experience. He has authored more than 20 peer-reviewed publications and has 3,000+ citations to date (including papers published in Nature and Nature Biotechnology describing Foresight’s liquid biopsy platform). Prior to founding Foresight, Dr. Chabon’s research focused on using cancer genomics to inform better personalized treatment strategies for patients. He completed his Ph.D and postdoctoral training at Stanford University under the co-mentorship of Dr. Max Diehn and Dr. Ash Alizadeh with whom he co-founded Foresight Diagnostics in 2020.


Clinical Dx Showcase:
Foresight Diagnostics

Foresight Diagnostics is developing a novel liquid biopsy test for the measurement of minimal residual disease (MRD). The improved sensitivity of the Foresight MRD assay can provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches.

Foresight’s Ultra-Sensitive Liquid Biopsy Improves MRD
Foresight’s ultra-sensitive liquid biopsy platform improves MRD detection rates in patients with B-cell lymphomas and solid tumors by tracking a unique class of somatic mutation, termed ‘phased variants’, that enables detection of ctDNA at levels as low as one part-per-million.

 Speaker Profile

Ph.D., CTO & Co-Founder, Day Zero Diagnostics

Biography
Miriam Huntley is the CTO and a Co-Founder of Day Zero Diagnostics, a healthcare startup spun out of Harvard University to develop a genomic sequencing-based rapid diagnostic for bacterial infections. As CTO of the company, Dr. Huntley leads the machine learning, computational biology, and software engineering development. Her work at the startup has earned her recognition as a TedMed Hive Innovator and as one of MedTech Boston 40 under 40 Healthcare Innovators. She received her BSc from MIT in Physics and her PhD in Applied Math at Harvard University, where she developed data analysis methods and theoretical models for problems in biology. Her research helped to discover fundamental structures in the three-dimensional folded genome, and has been covered widely in the public media by outlets such as NPR, Forbes, and the Smithsonian Museum.


Clinical Dx Showcase:
Day Zero Diagnostics

Day Zero Diagnostics is an infectious disease diagnostics company using whole-genome sequencing and machine learning to combat the rise of antibiotic-resistant infections.

Definitive Clonality Determination in Hospital-acquired Infection
Introducing epiXact, a rapid WGS-based service that provides hospitals with definitive and accurate answers for infection transmission investigations. epiXact computes pathogen relatedness at the single nucleotide level using a high-resolution SNP based pipeline enabling the highest confidence in clonality determination.

 Speaker Profile

Ph.D., OncoKB Scientist, Memorial Sloan Kettering Cancer Center

Biography
Dr. Nissan is a scientific manager for OncoKB, Memorial Sloan Kettering's (MSK's) precision oncology knowledge base. She contributes to and oversees the curation, maintenance and output of OncoKB's scientific content. Prior to her work with OncoKB, Dr. Nissan was both a graduate student and a postdoctoral fellow in the lab of Dr. David Solit at MSK, studying the functionality of genomic alterations in melanoma and bladder cancer.


Clinical Dx Showcase:
Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center in New York City, the world’s oldest and largest private cancer center and one of 51 NCI-designated Comprehensive Cancer Centers, has 135 years of experience dedicated to exceptional patient care, innovative research, and outstanding educational programs.

OncoKB: MSK’s Precision Oncology Knowledge Base
OncoKB, MSK’s precision oncology knowledgebase, contains expert-curated information about the biological and clinical relevance of cancer mutations. It is used to annotate 12000 MSK patient sequencing reports annually. OncoKB is the first somatic human variant database to be partially FDA-recognized.

 Speaker Profile

M.D., M.P.H., FACP, Chief Medical and Scientific Officer, InterVenn BioScience

Biography
Klaus Lindpaintner, MD, MPH, FACP, Chief Scientific and Medical Officer at InterVenn Biosciences, previously held senior positions at Pfizer as Sr. VP and Global Head, Human Genetics and Computational Biomedicine, at Hoffman-La Roche, as Distinguished Scientist and Global Head, Roche Center for Medical Genomics, spearheading the company’s efforts in personalized health care; as CSO at Thermo-Fisher-Scientific; and on the faculty of Harvard Medical School. Klaus has co-authored some 250 scientific papers, and holds honorary and adjunct professorships at several academic institutions. He serves on numerous boards, working groups, and advisory panels for trade organizations, regulatory authorities, and non-governmental organizations on issues related to the successful implementation and leverage of novel technologies in health care. Klaus graduated from Innsbruck University Medical School with a degree in medicine, and from Harvard University with a degree in public health. He pursued post-graduate training and specialization in internal medicine, cardiology, and clinical and molecular genetics in the US and Germany and is a Diplomate of the Boards in these specialties.


Clinical Dx Showcase:
InterVenn BioScience

InterVenn has developed a unique technology platform that combines high resolution mass spectrometry with high throughput artificial-intelligence powered data processing, allowing interrogation of the human glycoproteome at clinical study scale.

Glycoproteomic Profiling: Powerful Predictor of Immunotherapy Responsef
Using InterVenn's platform we have been able to demonstrate that serum glycoprotein profiles are powerful predictors of likely response or non-response to checkpoint inhibitors, clearly superior to currently available biomarkers across a range of indications and drug molecules.

 Speaker Profile

M.D., Ph.D., CEO, Apostle Diagnostics

Biography
Dr. Ge’s work focuses on the innovations in the public health and life science sector. Prior to Apostle, he was Director of Bioinformatics at Gilead Sciences between 2011 and 2016. Between 2008 and 2011, he was Assistant Professor at Duke University School of Medicine, where he was also a member of U.S. NIH NHGRI Special Emphasis Panel. He and colleagues discovered the IL28B genetic variants associated with clinical response to anti-HCV treatment, published in Nature in 2009.


Clinical Dx Showcase:
Apostle Diagnostics

Apostle Inc is a biotechnology company in San Jose, CA. Apostle responds to the COVID-19 pandemic with a Viral RNA Isolation System that has processed over 12 million clinical samples, as well as a CLIA lab helping international travelers.

Apostle COVID-19 RNA Extraction System
This presentation illustrates the effective detection of SARS-CoV-2 using the Apostle COVID-19 Viral RNA Isolation Automation System and qRT-PCR from over 12 million samples in clinical lab settings. A CLIA lab helping international travelers is also discussed.

 Speaker Profile

CEO, Todos Medical

Biography
Gerald Commissiong is President & CEO Todos Medical Ltd. (OTCQB: TOMDF), in addition to Amarantus Bioscience Holdings, Inc. and interim-CEO of Breakthrough Diagnostics, Inc., Todos’ joint venture with Amarantus. Mr. Commissiong has been responsible for Amarantus’ strategic transactions, licensing, research collaborations, mergers & acquisitions in therapeutics and diagnostics, as well as fund raising, having raised over of $50 million since inception. Prior to co-founding Amarantus, Mr. Commissiong played professional football for the Calgary Stampeders of the Canadian Football League. Mr. Commissiong received a B.Sc. in Management Science and Engineering with a focus on Financial Decisions from Stanford University.


Clinical Dx Showcase:
Todos Medical

Todos Medical is a commercial in vitro diagnostics company focused on developing novel, convenient tests for the early detection of COVID-19, cancer and neurodegenerative disorders.

Tollovir: Phase II Covid-19 Antiviral Drug Candidate
Tollovir: Phase II, Antiviral 3CL-Protease Inhibitor for Hospitalized Covid-19 Patients

 Speaker Profile

Ph.D., Research Scientist, SalivaDirect, Yale School of Public Health

Biography
Wyllie is credited with pushing forward on the use of saliva as a superior sample for creating high-quality, low-cost testing. Having worked with saliva as a clinical specimen for bacterial detection for almost 10 years, Wyllie is an expert in the laboratory methods required for working with saliva and skillfully applied these for SARS-CoV-2 detection. Her innovation throughout the pandemic and her commitment to open science has led to the development of freely available PCR testing protocols that have enabled laboratories across the US to rapidly implement accessible SARS-CoV-2 testing programs. Coupled with public health guidance, Wyllie’s team has devoted their efforts to the safe re-opening of communities and to keeping kids in school. The use of saliva as a sensitive and reliable sample type can alleviate many of the bottlenecks encountered in the mass testing strategies required to control infectious disease outbreaks.


Clinical Dx Showcase:
Yale School of Public Health

SalivaDirect is more than a test protocol: it is a true community partner working to expand affordable, equitable COVID-19 testing solutions. We offer an innovative open-source PCR-based method for the clinical detection of SARS-CoV-2, while supporting local leaders navigating the pandemic response.

SalivaDirect: A Simplified and Flexible Platform for Accessible SARS-CoV-2 Testing
SalivaDirect™ was developed to increase access to testing while democratizing the testing process. This was achieved by challenging high testing costs and replacing rigid, expensive practices with a cost-effective, open-source protocol that allows for numerous substitutions along its streamlined process.

 Speaker Profile

Ph.D., Co-founder and Chief Strategy Officer, Genetika+

Biography
Genetika+ is focused on personalizing treatment in the mental health space, with a first product focusing on optimizing drug choice in depression. Prior to co-founding Genetika+ , Daphna was Chief Scientific Officer at Ibex Medical Analytics, a digital health company developing AI-based cancer diagnostics, and before that, she served as Head, Personalized Medicine and Diagnostics at Teva Pharmaceuticals, where she supported the discovery, development and differentiation of Teva’s pipeline drugs, in collaboration with the Israeli healthcare sector and multinational companies. Daphna joined Teva after having led biomarker and diagnostic development activities within the pipeline of multiple top-10 pharma and fortune 500 companies. She served in several roles with increasing responsibility at Selventa, a system's biology company focused on personalized medicine, and founded the Israeli branch of the company, as Global Head of Diagnostics. Daphna trained as post-doc at Harvard University, after receiving her PhD in Medical Sciences from the Technion.


Clinical Dx Showcase:
Genetika+

Genetika+ personalizes treatment in the mental health space, initially focusing on depression. The Genetika+ platform uses innovative technology to predict the best drug treatment for each patient, enabling faster treatment, fewer side effects, and lower dosing.

Brain in a Dish: Personalizing Treatment in Depression
Major depression is a leading cause of health-related burden globally, further exacerbated by Covid-19. Despite the availability of many antidepressant on the market, most patients do not effectively respond to the prescribed treatment. Genetika+’s RxMine platform converts patients' blood cells into neurons, which in turn are used to screen for the optimal drug for each individual. By combining the patient’s genetics and medical history into an AI-based algorithm, a tailored report describes the optimal drug for each patient.

 Speaker Profile

Ph.D., CEO, Novosanis

Biography
Vanessa Vankerckhoven is CEO and co-founder of Novosanis, a University of Antwerp spin-off company specialized in medical devices. She is a passionate entrepreneur and in charge of the day to day management of Novosanis next to the strategic marketing of the oncology business within the Molecular Solutions Business Unit for Orasure Technologies. She holds a PhD in Medical Sciences and has a profound interest in infectious diseases, medical devices, diagnostics, microbiology, and vaccinology. She has a good track record of scientific publications as author and co-author in international peer-reviewed journals and has written several book chapters. Previously, she was appointed Research & Innovation Manager of the Vaccine and Infectious Disease Institute (VAXINFECTIO) at the University of Antwerp, Belgium, where she was responsible for setting-up and maintaining collaborations with industry and exploring opportunities for valorisation, including patents and spin-off creation.


Clinical Dx Showcase:
Novosanis

Novosanis is a wholly owned subsidiary of OraSure Technologies Inc (NASDAQ: OSUR) and an innovative developer and producer of medical devices improving the quality of diagnostic tests for infectious diseases and oncology.

Urine as a Non-invasive Liquid Biopsy for Oncology Applications
Urine is an exciting sample type that contains relevant biomarkers and has shown potential as a non-invasive liquid biopsy for detection and monitoring of urological, gynecological and systemic cancers. Urine sampling is also beneficial as it is easy, quick and non-invasive.

 Speaker Profile

Ph.D., Chief Executive Officer, Member of the Board of Directors and Co-Founder, Artidis AG

Biography
Marija Plodinec co-founded ARTIDIS AG and in November 2017 became the CEO and a Member of the Board of Directors. She studied physics in Zagreb and received her doctorate in 2010 from the University of Basel. For twelve years, she has driven the development of ARTIDIS, a medical device for fast and early diagnosis of breast cancer based on a unique nanomechanical biomarker, bringing the technology from basic research to the first clinical studies. Marija Plodinec is a recognized expert in the field of physical sciences in oncology and has co-authored important scientific papers and patents in this field. She is also a member of several international organizations focusing on cancer research and its clinical applications. Under her leadership, ARTIDIS fundraised more than 25M USD, successfully completed the large clinical study on 545 patients in Switzerland, grew to +40 FTE and partnered up with leading US pharmaceutical and clinical institutions.


Clinical Dx Showcase:
Artidis AG

ARTIDIS AG is a clinical stage medical technology company developing the first nanotechnology platform for tissue analysis combined with a digital data platform intended for broad use in drug discovery, tissue engineering as well as for rapid diagnostics and personalized treatment optimization.

ARTIDIS: Changing the Paradigm of Tissue Analysis
ARTIDIS: Changing the paradigm of tissue analysis with a novel nanotechnology platform that delivers personalized patient treatment strategies and accelerates drug development.

 Speaker Profile

M.D., Ph.D., CEO, Twinstrand Biosciences

Biography
Dr. Jesse Salk is a medical oncologist and a Co-Founder of TwinStrand Biosciences. His research interests lie in studying somatic evolution and the genomic processes that occur on the continuum between “normal”, preneoplastic and cancer, and applying this to knowledge to clinical medicine. He developed the ultra-high accuracy Duplex Sequencing technology with colleagues at the University of Washington, where he completed his medical and graduate degrees as well as clinical training. Since 2017, Dr. Salk has led TwinStrand, applying Duplex Sequencing to new areas of high sensitivity early and residual cancer detection, evolution of drug resistance and genetic toxicology, among other fields. He holds a clinical faculty appointment at the University of Washington and continues to care for cancer patients part time at the VA Puget Sound in Seattle.


Clinical Dx showcase:
Twinstrand Biosciences

TwinStrand develops ultrasensitive Duplex Sequencing-based assays for research and clinical applications in cancer, cancer therapeutics and other areas of basic science and clinical medicine.

Duplex Sequencing for Gene Editing and Cell Therapy Applications
Duplex Sequencing enables an unprecedented level of NGS accuracy, with error rates below one-in-ten-million. The technology is ideally suited to detection of exceptionally low frequency DNA variants. Here we present Duplex Sequencing for cutting-edge gene editing and cellular therapy applications.

 Speaker Profile

CEO, OncoCyte

Biography
Ronnie Andrews joined OncoCyte as CEO in July 2019. Prior to this, Ronnie was the founder and principal of the Bethesda Group LLC, a boutique consulting group focused on helping small and mid-stage diagnostic companies move emerging diagnostic content and platforms into the marketplace. Ronnie has close to 30 years of experience in the US Clinical and Molecular Diagnostics industry. He served as the President of the Genetic Science Division for Thermo Fisher Scientific until December 2014. Prior to this Ronnie held a number of other high-profile executive roles including CEO of Clarient, a public company on the NASDAQ which was sold to General Electric Healthcare in 2010.


Clinical Dx showcase:
Oncocyte

Oncocyte is a molecular diagnostics company dedicated to providing actionable answers to physicians and patients at critical decision points across the lung cancer care continuum.

 Speaker Profile

Ph.D., Director of Business Development, Genialis Inc.

Biography
Dr Schlicher heads commercial work at Genialis, where she recently led strategy and launch for Genialis ResponderIDTM. She brings over 20 years of experience in precision medicine, diagnostics, and entrepreneurial leadership. Robyn has patented inventions in regenerative medicine and is a recognized global expert in advanced analytical techniques. Her publication on drug delivery by targeted cavitation has been widely cited and highlighted worldwide. She earned her doctorate in bioengineering from Georgia Institute of Technology and Emory University, receiving National Institutes of Health and Medtronic fellowships. In 2021, Robyn became an inaugural fellow of On Deck Health (ODH1).


Clinical Dx Showcase:
Genialis, Inc.

Genialis is a computational precision medicines company unravelling complex biology to find new ways to address disease. Its clinical biomarker discovery platform, ResponderID™, defines, models, and validates actionable biomarkers and optimally positions novel drugs to accelerate translational research and clinical development.

Machine-Learning for Clinical Biomarker Discovery
The research space churns out biomarkers while the clinical space struggles to deliver them for patient reporting. I will discuss biomarker development challenges and describe ML-enabled and ML-enabling solutions Genialis uncovered on the road to validating a clinical assay.

 Speaker Profile

CEO, Quantum Insights Inc.

Biography
Bernard Chen trained in traditional statistics before managing product and analytics teams for companies like Apple, Ubisoft, and Scopely that could generate 100k samples of user data in days. Oncological data is more complicated to acquire and more complicated in its interactions, but the underlying problems for anyone working with data remain the same: 1) Have I asked my questions correctly? 2) Do I have the right data to answer my questions? He co-founded Quantum Insights with Stanford physicist, Marvin Weinstein, in 2017 to apply a quantum mechanics-based algorithm to big data. QI’s algorithm isn’t better than other algorithms - it’s different. That difference frequently identifies un-predicted associations that can be used to classify patients or sub-type diseases for our partners in pharma.


Clinical Dx Showcase:
Quantum Insights Inc.

Quantum Insights uses principles from quantum mechanics to identify diagnostic signatures and improve patient outcomes.

Finding Off-Label Treatments for Rare Diseases
Kidney renal papillary cell carcinoma (KIRP) has no FDA-approved treatment. By clustering cancers in the TCGA, we were able to identify the 5 most-similar cancers. Three drugs were identified that targeted genes which were significant in our classification of KIRP.

 Speaker Profile

M.D., FABP, Lead, Medical Affairs, Rady Children’s Institute for Genomic Medicine

Biography
Erika Allred, MD, FABP, is a board-certified pediatrician working on multiple projects with Rady Children’s Institute for Genomic Medicine. In addition to her clinical duties, Dr. Allred is assisting partner sites – other children’s hospitals and health systems in the US and around the world – with their outreach and education regarding the clinical use and validity of rapid Whole Genome Sequencing™ in critically ill pediatric patients. Her recent research includes the evaluation of pediatric transplant patient outcomes along with the genomics of kidney disease, specifically the genetic overlap of congenital anomalies of the kidneys and urinary tract (CAKUT) system and congenital heart disease (CHD). Previously, Dr. Allred has worked on devising novel targeted therapies for muscular dystrophies, a group of neuromuscular diseases that cause weakness and degeneration of the skeletal muscles. Dr. Allred is currently completing her pediatric nephrology fellowship through UC San Diego School of Medicine and UC San Diego Health where she also did her residency. She received her Doctor of Medicine degree from the University of Nevada, Reno School of Medicine, after graduating Summa Cum Laude from the University of Nevada, Reno.


Clinical Dx showcase:
Rady Children’s Institute for Genomic Medicine®

Rady Children’s Institute for Genomic Medicine® is transforming neonatal and pediatric healthcare by offering the fastest delivery of rapid Whole Genome Sequencing™ to enable prompt diagnosis and targeted treatment of critically ill newborns and children in intensive care.

Changing Lives in Real Time with rWGS
Rady Children’s Institute for Genomic Medicine® performs the world’s fastest rapid Whole Genome Sequencing™, diagnosis, and reporting to drive Rapid Precision Medicine and unleash the power of rWGS to end the therapeutic odyssey for children suffering from rare genetic disease.

 Speaker Profile

Ph.D., Director, Translational Science and Strategy, Personal Genome Diagnostics (PGDx)

Biography
Jennifer Jackson, Ph.D. is the Director of Translational Science and Strategy at Personal Genome Diagnostics (PGDx). Jennifer has over 15 years of oncology-focused research and industry experience including 8 years focused on liquid biopsy in the clinical setting. She received her B.S from the University of Florida and her Ph.D. in Biochemistry and Molecular Biology from Emory University School of Medicine. During her postdoctoral appointment in the Department of Surgery at Boston University Medical Center, her training focused on assessing the clinical utility of ctDNA as a biomarker for early detection of cancer and monitoring of minimal residual disease in response to therapy using digital PCR and next-generation sequencing (NGS). Following her postdoctoral training, she joined RainDance Technologies and later, Bio-Rad Laboratories as a Global Market Development Scientist and served as a trusted advisor to the company and to the customer base to facilitate market access and scientific success. Since 2017, Dr. Jackson has brought her expertise in precision medicine to PGDx to support the goals of driving clinical expansion and uptake of NGS, building industry partnerships and academic collaborations, and helping to advance new applications within oncology diagnostics.


Clinical Dx showcase:
Personal Genome Diagnostics (PGDx)

Personal Genome Diagnostics (PGDx) is Empowering the Fight Against Cancer by unlocking actionable information from the genome. We are developing an innovative portfolio of regulated tissue-based and non-invasive liquid biopsy genomic products for laboratories worldwide.

Enabling Precision Oncology through Decentralized NGS-based Solutions
Personal Genome Diagnostics is empowering the fight against cancer by unlocking actionable information from the genome. We have developed an innovative and comprehensive portfolio of RUO and IVD tissue-based and non-invasive liquid biopsy genomic profiling solutions for use in laboratories worldwide.

 Speaker Profile

M.D., Ph.D., Medical Director, University of South Alabama

Biography
Thuy Phung, MD, PhD is associate professor and medical director of molecular pathology & dermatopathology at the University of South Alabama. She has been spearheading efforts to enhance molecular diagnostics for cancer patients in underserved areas in the Gulf Coast region by establishing rapid single-gene testing as well as actionable, cost-effective next generation sequencing (NGS) assays. She is the lead author of Pediatric Dermatopathology, a comprehensive textbook in the field. Dr. Phung is passionate about global health. She co-founded the award-winning Vascular Anomalies Center in Ho Chi Minh City, Vietnam, which cares for thousands of underserved children with vascular birthmarks, and is leading efforts to establish molecular diagnostics for these disorders.


Clinical Dx Showcase:
University of South Alabama

University of South Alabama is an academic healthcare system comprised of university hospital, women & children's hospital, cancer institute and affiliated medical clinics that provide quality healthcare services to communities across the Gulf Coast region.

Establishing Molecular Testing in Communities
Molecular diagnostics provide important genetic information for informed precision cancer care. However, molecular testing, such as broad-panel testing, remains underutilized in oncology practices in community/small laboratory setting. The presentation’s aim is to explore and address the gap in molecular testing in underserved communities.

 Speaker Profile

Chief Executive Officer, Exai Bio Inc.

Biography
TBA


Clinical Dx Showcase:
Exai Bio Inc.