2014 Archived Content

Cambridge Healthtech Institute’s Inaugural

Biospecimen Science and Sample Prep

Enabling Sample-Centered Precision Medicine

February 10-12, 2014 | Moscone North Convention Center | San Francisco, CA


Day 1 | Day 2 | Day 3 | Download Brochure 

Wednesday, February 12

7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

8:00 Plenary Keynote Session (Click Here For More Details) 

9:45 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall


10:35 Chairperson’s Remarks
Nazneen Aziz, Ph.D., Director, Molecular Medicine, Transformation Program Office, College of American Pathologists  

10:40 College of American Pathologists/CLIA Standards for Next-Generation Sequencing and Proficiency Testing

Nazneen Aziz, Ph.D., Director, Molecular Medicine, Transformation Program Office, College of American Pathologists

Within 5 years of its introduction and widespread use in research, NGS is transforming molecular medicine. NGS has been adopted into clinical testing far more rapidly than any other prior molecular technology. The embracing of a new technology for routine diagnostics usually takes 10 - 14 years or more. Despite its rapid adoption into clinical testing, NGS has a number of intricacies associated with its implementation that are unfamiliar to the clinical laboratory. This talk will address the recently developed CAP/CLIA standards and PT being developed for different parts of the NGS workflow in clinical testing.

11:10 Quantitative Assessment of Tissue Sample Quality

Shannon McCall, M.D., Director, Duke Biospecimen Repository and Processing Core, Pathology, Duke University School of Medicine

CAP Accreditation offers an opportunity for standardization of practice. Today, there are few resources for biobanks that seek external verification/quality assurance of how they are performing and how they are conforming to benchmark standards of quality. The CAP Biorepository Accreditation Program features a unique peer-based inspector model that integrates education and a sharing of best practices to advance quality.

11:40 Improving Clinical Laboratory Quality through Effective Proficiency Testing: Practical Considerations in an Evolving Virtual World

John Osiecki, Ph.D., Director, Scientific Affairs, Roche Molecular Systems

Proficiency testing programs are so important to maintaining acceptable levels of performance in molecular diagnostic laboratories. Addressing current challenges, discussing the newest technologies (sequencing), and what the future holds for quality assurance and proficiency testing are just a few of the exciting topics this presentation will cover.

12:10 pm Session Break

12:20 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:00 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing


1:40 Chairperson’s Remarks
Jane Emerson, M.D., Ph.D., Professor of Clinical Pathology, University of Southern California 

1:45 Biospecimen Quality Appraisal at a Cancer Tissue Bank

Teri A. Longacre, M.D., Professor of Pathology; Director, Tissue, Procurement Facility, Stanford Cancer Center

Quality control of biospecimen banking in a high volume academic cancer center requires a dedicated anatomic pathologist with specific expertise in tumor pathology. Methods to ensure high quality biospecimen banking, storage, and distribution based on best practices and evidence-based standards are presented.

2:15 Quantification of HER2 Heterogeneity in Patient Samples

Elena Geretti, Ph.D., Senior Scientists, Merrimack Pharmaceuticals

The currently FDA-approved methods for HER2 quantification are not able to give a quantitative measure of HER2 heterogeneity of expression. We have developed a novel immunofluorescence assay to quantify HER2 on FFPE samples. Coupled with automated image analysis, our assay is able to quantify HER2 expression at the single cell level, and may constitute a means to understand the predictive and/or prognostic role of the heterogeneity of HER2 expression for patient response to HER2-targeted therapies.

2:45 Sample Type Bias in the Analysis of Cancer Genomes: How Admixed Normal Cells, Intratumoral Heterogeneity, and ex vivo Growth Impact Cancer Genomic Analyses

David Solomon, M.D., Ph.D., Anatomic Pathology, PGY-2, University of California, San Francisco

Techniques have emerged which now allow us to interrogate the entire genome of human cancers and to define the genetic alterations that drive tumorigenesis. When performing these genomic analyses, it is important to understand the impact that admixed normal cells, intratumoral heterogeneity, and ex vivo growth can have on the results. This talk will discuss these issues and highlight one study comparing genomic analyses performed on glioblastoma tumor samples of differing types (primary tumors, primary xenografts, primary cultures, and established cell lines).

3:15 Q&A with Session Speakers 

3:45 Refreshment Break


4:00 Chairperson’s Remarks

4:05 Nucleic Acid Target Enrichment from Clinical Samples: Separating the Needle from the Haystack

Michael A. Lewinski, Ph.D., Senior Director, Clinical Research, Microbiology, Roche Molecular Systems, Inc.

Detection of nucleic acid sequences in clinical samples present in low concentration relative to background is important across all disciplines of medicine, including cancer, prenatal diagnosis and infectious diseases. Target enrichment methods concentrating sequences of interest and removing irrelevant nucleic acid and potential inhibitors from clinical samples have been described and have been shown to improve assay sensitivity and patient outcomes. This session focuses on target enrichment methods for improved detection of low copy number targets directly from clinical samples.



4:35 Photopolymer Separators for Standardizing Cell-Fractions in Blood Specimens

Jane Emerson, M.D., Ph.D., Professor of Clinical Pathology, University of Southern California

Photopolymers are incorporated into separator gels in evacuated blood collection tubes in order to create a solid barrier at the interface between serum/plasma and blood cells. We have shown cell-free DNA and mRNA from exosomes is reliably analyzed from these specimens. This technique allows for complete recovery of the cell-free fraction which will enable standardization of low concentration analytes.

5:05 Serum Blood Collection Tube Additive Interference on Clinical Assays

Raffick Bowen, Ph.D., MHA, MT, Clinical Associate Professor of Pathology, Stanford University Medical Center

Components of blood collection tubes, such as stoppers, stopper lubricants, tube walls, surfactants, clot activators, and separator gels may add materials to blood, adsorb components, or interact with protein and cellular components. As a consequence of the multiple and complex interactions of collection devices with blood specimens, collection devices can be a major source of potential error in the pre-analytical phase of laboratory testing. Understanding the interactions of collection devices with blood specimens is essential for the performance of accurate laboratory testing. This presentation will discuss some tube-specific interference on clinical assays, particularly immunoassays.

5:35 Close of Conference Program

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