|Laboratory Developed Tests & CLIA Certified Diagnostics Laboratory (2/8)|
|2014/1/20 15:28:59 ｜ 浏览：1176 ｜ 评论：0|
SINO-AMERICAN BIOMEDICAL & PHARMACEUTICAL PROFESSIONALS ASSOCIATION
Medical Device and Diagnostics Forum III
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.
8:45 Opening Remarks
9:00 Richard Ding, CEO, bioTheranostics
9:30 Dr. David Craig, Deputy Director of Bioinformatics, TGen
10:00 Dr. Mao Mao, Senior VP, Translational Bioscience and Diagnostics, WuXi AppTec
10:30 Coffee Break
11:00 Panel Discussions
Moderator Dr. Hua Gong, Genoptix
Dr. Jing Liu, Knobbe Martens
Dr. Michael Jin, Managing Director, TEEC Angel Fund
Kyle Fetter, Associate VP of Integrated Care Initiatives, XiFin
Dr. Jorge Garces, COO, AltheaDx
Janna Sipes, Compliance Attorney, Life Technologies
12:20 Closing Remarks
8:00 am - 2:00 pm, Saturday, February 8, 2014
Knobbe Martens（12790 El Camino Real, San Diego, CA 92130）
$20 online by January 25; $10 for students and post-docs. $40 onsite.
Registration fee includes parking, program brochure, breakfast, coffee, and lunch.