Sam Rua HTG Molecular Diagnostics VP of Regulatory Affairs is Keynote Presenter at TIDES Conference
TUCSON, Ariz. (May 14, 2012) – Sam Rua, vice president of regulatory affairs and quality systems at HTG Molecular Diagnostics, will offer a keynote presentation, “Update on Commercialization of RUO and IUO Products and Oversight of Lab-Developed Tests,” at the 2012 TIDES Oligonucleotide and Peptide Research, Technology and Development conference in Las Vegas on Tuesday, May 22.
Mr. Rua’s presentation will offer an industry perspective on the recently released FDA guidance for commercialization of RUOs and IUOs as well as on potential new guidance on LDTs. Attendees will receive a 360 degree view of the current and future state of the regulatory landscape for the commercialization of RUOs, IUOs, and LDTs.
Sam Rua, vice president of regulatory affairs and quality systems, joined HTG Molecular in 2011, and directs the quality systems organization and global regulatory initiatives. Prior to joining HTG, Mr. Rua served in a variety of quality and regulatory roles with Ventana Medical Systems, a member of the Roche Diagnostics Group. Mr. Rua has successfully led applications for PMA approvals and clearances for multiple IVD and companion diagnostic tests. His career includes positions as VP of global regulatory and clinical affairs at Beckman Coulter, and executive director of quality and regulatory at Third Wave Technologies, Inc. (now Hologic), where he led the regulatory and clinical strategies for the Invader® UGT1A1 test and the Invader® HPV test. Mr. Rua received his B.S. in Microbiology from the University of Arizona.