Next Generation Dx Summit

 

SC6  CIRCULATING TUMOR CELLS AND CANCER STEM CELLS FROM RESEARCH TO CLINIC   

 

2:00 Opening Remarks 

Moderator: Marek Malecki, M.D., Ph.D., President, Phoenix Biomolecular Engineering Foundation and Visiting Professor, University of Wisconsin, Madison

 

2:05 CTC Assays in Clinical Practice and Clinical Trials 

Minetta C. LiuMinetta C. Liu, M.D., Associate Professor, Department of Oncology and Associate Professor, Department of Laboratory Medicine and Pathology, Mayo Clinic Cancer Center

Prospective studies have demonstrated that the enumeration of circulating tumor cells (CTCs) has clinical utility when used in conjunction with radiographic imaging and clinical evaluations in the setting of metastatic breast cancer. Ongoing work is focused on the potential utility of phenotypic and genotypic characterization of CTCs as a pharmacodynamic endpoint in clinical trials.

 

2:35 Streamlining CTC Tests and POC Devices into Clinics 

Marek MaleckiMarek Malecki, M.D., Ph.D., President, Phoenix Biomolecular Engineering Foundation and Visiting Professor, University of Wisconsin, Madison

Cancer is a genetic/genomic disease characterized by heterogeneity of the cancer cell populations detected in every patient. Therefore, molecular analysis is necessary for designing methods of screening and prevention, issuing diagnosis and prognosis, and designing targeted and personalized therapy. We and others promote genetic and genomic analysis based upon isolation of the spectra of single cells from every tumor followed by the detailed analysis of their genome, transcriptome, and proteome. Furthermore, we try to make the elements of this molecular analysis incorporated into the personal point of care devices as the integral parts of telemedicine.

 

3:05 NIH Support for CTC and POC Technology Research 

Avraham Rasooly, Ph.D., Special Assistant for Cancer Technologies and Translational Research, NCI NIH 

 

 

3:35-4:00 Refreshment Break 

 

4:00 FDA Considerations for CTC Clinical Studies 

 Abraham TzouAbraham Tzou, M.D., Medical Officer, FDA CDRH

An important issue for CTC clinical investigations is the need for an investigational device exemption. This presentation provides FDA perspective on significant risk and other factors relevant to its oversight of in vitro diagnostic device clinical studies.

4:30 Talk Title to be Announced 

 

5:00 Close of Course   

 



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