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WEDNESDAY, AUGUST 22

11:00 am Registration

2:30 Refreshment Break in the Exhibit Hall with Poster Viewing

Technology in the Service of Companion Diagnostics

3:15 Chairperson’s Opening Remarks

3:20 What Will it Take to Realize the True Potential of Companion Dx?

Michael Nohaile, Ph.D., Global Head, Novartis Molecular Diagnostics

Generally speaking, today’s diagnostics are simple profiles of single markers. While there has been tremendous hype around the recent advances in Next Generation Sequencing Technology (NGS), by itself, NGS is just another platform. To truly revolutionize companion dx and the way medicine is practiced, we need to address a host of clinical, scientific, technical, political and societal barriers. In his talk, Dr. Nohaile will discuss the critical steps in this process.

3:50 Companion Diagnostics of the Future: LDTs and Complex Gene Signatures Using Next Generation Sequencing

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

As technology evolves in the genomics space to incorporate Next Generation Sequencing, it is very conceivable that the companion diagnostics of the future will be complex gene signatures. As an extension, these diagnostics could very well be laboratory developed tests (LDTs) and not traditional kits or point-of-care solutions. There is a need for all stakeholders in these spaces to understand the upside and value in these kinds of tests and paradigm shifts to enable higher level of patient care.

4:20 Fully Automated Platform for Companion Diagnostics

Richard A. Montagna, Ph.D., Senior Vice President, Scientific Affairs, RHEONIX, Inc.

The Rheonix CARD® system is able to automatically process a wide range of clinical specimens for companion diagnostic applications. Such samples as buccal swabs, whole blood, fresh tissue and FFPE samples can be placed into the system which will automatically lyse cells, extract and purify DNA, multiplex PCR amplify targets of interest and then detect the resulting amplicons on an integrated DNA microarray. Examples of using the CARD technology to detect the presence of SNPs associated with warfarin sensitivity, Plavix sensitivity and KRAS markers will be provided.

4:35 Single Molecule Arrays (SiMoA) for Ultrasensitive Protein Detection in Companion Diagnostics

David C. Duffy, Ph.D., Vice President, Research, Quanterix Corporation

SiMoA is a game-changing technology for the quantification of low concentrations of proteins in blood. This fully automated platform enables high throughput, multiplexed measurement of proteins at low cost. We will describe the potential for SiMoA to have a dramatic impact on the development of companion diagnostics for antibody therapeutics.

4:50 A New Paradigm for Advancing Personalized Medicine: The Contract Diagnostics Organization

Philip D. Cotter, Ph.D., F.A.C.M.G., Co-Founder, ResearchDx, LLC

5:05 Companion Diagnostic using Multiparameter Flow Cytometry for Nucleoside Transporter hENT1 in Acute Myeloid Leukemia 
Bruce H. Davis, M.D., President & Founder, Trillium Diagnostics, LLC
The human Equilibrative Nucleoside Transporter 1 (hENT1) transports nucleoside analogs such as cytarabine (ara-C) and gemcitabine into the cells. We developed a flow cytometric assay for hENT1 to identify patients that might benefit from ara-C alternatives, such as ElacytarabineTM due to low hENT1 expression to serve as a companion diagnostic. We report our experience with the flow cytometric assay for hENT1 in blood (PB) and bone marrow (BM) specimens using a ratiometric method.  The studies demonstrate variable hENT1 expression in leukocytes and nearly a ten-fold range of hENT1 expression among AML blasts. This diagnostic assay for hENT1 expression could be integrated into clinical practice and help personalize medicine by rapidly identifying alternative AML therapies when hENT1 expression is decreased.

5:20 Finding the Right Tool: Tailoring the Assay to the Clinical Need
Charles (Buck) Strom, M.D., Ph.D., Senior Medical Director, Genetics, Quest Diagnostics Nichols Institute
There are several categories of genetic variants associated with disease, drug response, or cancer prognosis. These include point mutations, triplet repeat expansions, small insertions and deletions (in-dels), large deletions and duplications, chromosomal translocations, and copy number abnormalities. There is an extensive variety of platforms to detect the variations. The concept that any single test, even whole genome sequencing (WGS) will be able to detect all of these variants is naive. This talk will use examples of clinical and companion diagnostic scenarios which would mandate use of a particular technology to optimize sensitivity and specificity and minimize costs.

 5:50  Sponsored Presentation
To be Announced

6:05 Close of Day

6:30- 8:30 pm Dinner Short Courses*

*Separate registration required

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