CALGARY, Alberta, Jan. 14, 2021 (GLOBE NEWSWIRE) — FluroTech Ltd. (TSXV: TEST) (OTCQB: FLURF) (“FluroTech” or the “Company”), is pleased to announce it has retained PandiaDx LLC (“PandiaDX”) for regulatory guidance and services in preparation of its regulatory submissions to the U.S. Food and Drug Administration.
Melina Cimler, Ph.D. is the CEO and Founder of PandiaDx. She is a senior quality, regulatory, and in vitro diagnostic device expert with more than 30 years of experience in the life science and FDA-regulated diagnostic industry, leading regulatory, quality systems, clinical affairs, research, and product development organizations, with a focus on precision medicine.
She currently serves on the Board of Directors of Nanostics, Inc., and is a Scientific Board member of Athira Pharma, Inc., as well as an Expert Consultant of NDA Partners LLC.
Dr. Cimler previously served as Senior Vice President of Regulatory & Quality at Adaptive Biotechnologies until April 2018. She was formerly Head of Global Quality and Vice President of Quality, Regulatory, Clinical, and Government Affairs at Illumina, Inc., where she defined and executed regulatory strategy, resulting in the first next generation sequencing platform to receive FDA marketing authorization. Dr. Cimler has held executive leadership positions in quality, regulatory, clinical, and government affairs at Beckman Coulter, Inc., Abbott Molecular, Gen-Probe, Inc. (now Hologic), and C.R. Bard, and was head of Product Development at Epitope, Inc. (now OraSure Technologies). Dr. Cimler holds a Ph.D. in Pharmacology from the University of Washington.
“We are honored to be working with Dr. Cimler as we prepare for the FDA submission process,” said Bill Phelan, CEO of FluroTest Systems Ltd. “Dr Cimler has a long history of success and is actively involved in providing guidance to a number of firms currently making FDA submissions. We will surely benefit from her guidance.”