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2013 Archived Content

October 21st, 2013
6pm - 9pm


Clinical Studies for the Development of Evidence-Based Diagnostics * 

Instructors: Catherine Schnabel, Ph.D., Vice President, Medical, Clinical & Regulatory Affairs, bioTheranostics, Inc.

Brock Schroeder, Ph.D., Director, Medical & Scientific Affairs, bioTheranostics, Inc.

Development of a strong clinical program for diagnostic tests requires consideration and integration of key strategic drivers such as clinical adoption, reimbursement, & regulatory filing based on a proposed indication for use.  In considering the appropriate use of new tests, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient’s clinical status (clinical validity), the risks and benefits resulting from test use (clinical utility), and the medical value of the test (health economics/outcomes).

This workshop will provide a basic framework for establishing comprehensive clinical evidence based on analytical validity, clinical validity, clinical utility, and health economics and effectiveness, and utilize a case study of the 92-gene assay, CancerTYPE ID to build these points.

  • Clinical study designs for biomarker research/Levels of evidence
  • Formulating clinical endpoints
  • Framework for clinical evidence
  • Data requirements for various stakeholders
  • Case study

October 22nd, 2013
5:30pm - 8:30pm


Reimbursement of Cancer Genomic Analysis * 

Instructors: Jerry Conway, Vice President, Reimbursement and Payer Strategy, Foundation Medicine, Inc.

Jorge Leon, Ph.D., President, Leomics Associates, Inc.

Genomic analysis of cancer has been established as an integral part of cancer patient management as well as of cancer clinical trials. The volume of this category of molecular testing is growing and more and more laboratories include it in the “test menu” and/or “services provided”. Hereby, the issue of reimbursement of clinical genotyping of cancers is at utmost importance for laboratories and molecular diagnostic companies. The situation is complicated by the fact that pharmaceutical companies working in the field of personalized oncology possess vested interest in these matters because many of the tests are falling in the category of companion diagnostics. The landscape of the diagnostics reimbursement in the health care industry is changing dramatically, as the usual mixed bag of payers is being compressed now by the reimbursement decisions of  the number one customer: The US Govermnent.

High value diagnostic tests that carry expensive price tags are under the radar of payers as potential waste or major drivers of cost savings and superior outcomes. The reimbursement decisions in this country are going to be gradually shifting from well defined or arbitrary codes to more analytical categories based on the clinical utility the tests bring to the system. Traditionally, Diagnostics and Pharmaceutical companies have not been used to this type of payment criteria, and therefore might not be fully prepared to successfully navigate this new turbulent waters.

In this workshop we will present, analyze and discuss the following points.

  • Overall situation of the reimbursement landscape today
  • Coding, Coverage, Policies and payment fees for cancer genomic tests
  • The Medicare /CMS new view of the value of new tests
  • The view from large Insurance payers
  • How to generate cost effectiveness data that payers will buy into
  • How to generate clinical utility data that payers will endorse
  • Case studies in Pathology, Molecular Diagnostics, Proteomics, Gene Expression, Nest Gen Sequencing.

*Separate Registration Required



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