WHENFebruary 08, 2014 @ 8:00am - 5:00pm

Laboratory Developed Tests (LDTs) and CLIA Certified Diagnostics Laboratory


Many diagnostics companies, especially in the area of genomics based testing for complicated genetic diseases and cancer, have taken a new pathway to commercialization for their diagnostics tests. Instead of getting FDA clearance or approval, they opt to offer laboratory-developed tests (LDTs) through their CLIA certified clinical diagnostics laboratories. This route allows the companies to access the market relatively quickly as formal FDA approval is not required. Although LDTs and CLIA labs have existed for decades, this recent development has brought them increased attention. At this forum, experts in the field will provide a comprehensive review of laboratory operations, test development, regulatory and clinical affairs, reimbursement, and intellectual properties in US and China.



8:00                Registration

8:45                Opening Remarks

9:00                CLIA Lab Drives Market Adoption of Novel Diagnostics

Richard Ding, CEO, bioTheranostics

9:30                Integrated analysis of RNA and DNA genome-wide sequencing for tumor/normal pairs for use in clinical studies

Dr. David Craig, Deputy Director of Bioinformatics, TGen

10:00               CLIA Lab in China – WuXi Genome Center’s Experience

Dr. Mao Mao, Senior VP, Translational Bioscience and Diagnostics, WuXi AppTec

10:30               Coffee Break

11:00               Panel Discussions

Moderator        Dr. Hua Gong, Genoptix

Panelists         Dr. Jing Liu, Knobbe Martens

Dr. Karen Liu, Partner, Kaiwu Capital

Kyle Fetter, Associate VP of Integrated Care Initiatives, XiFin

Dr. Jorge Garces, COO, AltheaDx

Janna Sipes, Compliance Attorney, Life Technologies

12:20                Closing Remarks

12:30                Lunch



When                                   8:00 am – 2:00 pm, Saturday, February 8, 2014

Where                                 Knobbe Martens (12790 El Camino Real, San Diego, CA 92130)

Registration                   https://www.123signup.com/register?id=dcxrt

$20 online by January 25; $10 for students and post-docs. $40 onsite.

Registration fee includes parking, program brochure, breakfast, coffee, and lunch.

 Corporate Sponsorship


For event sponsorship, please contact sponsorship@sabpa.org


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