Chairperson: Darryl Irwin, PhD, Vice President, Scientific Affairs, Agena Bioscience
12:00 Development and Validation of a Large-Scale and Less Invasive SARS-CoV-2 Test
Cynthe Sims, PhD, HCLD (ABB), Technical Director, AdvaGenix
AdvaGenix is a CLIA Certified Laboratory located in Rockville, MD. Dr. Cynthe Sims, Technical Director at AdvaGenix, will discuss AdvaGenix's need to transition to a high-throughput test and will present their laboratory’s high-throughput and less-invasive
solution for SARS-CoV-2 testing using an FDA-approved saliva self-collection device. AdvaGenix is in the process of submitting their test to the FDA for Emergency Use Authorization for SARS-CoV-2 diagnostic testing of saliva specimens.
12:20 Pivoting a Precision Medicine Laboratory for SARS-CoV-2 Testing
Brent Zanke, MD, PhD, Chairman and CMO, Arctic Medical Laboratories
Arctic Medical Laboratories delivers regulated genetic testing services to doctors, aiming to provide precision medicine to patients. Dr. Brent Zanke, CMO of ArcticDx will present their laboratory’s validation of saliva as a specimen for SARS-CoV-2
testing and the use of high-throughput robotic technology to provide results with a fast turnaround time of 24 hours from sample receipt.
12:40 High-Throughput and Low-Cost Solution for SARS-CoV-2 Testing
Darryl Irwin, PhD, Vice President, Scientific Affairs, Agena Bioscience
The SARS-CoV-2 coronavirus pandemic has created an enormous challenge for health systems, clinical laboratories, public health officials and communities worldwide. Testing shortages remain a bottleneck in the battle to curtail COVID-19 spread. Agena Bioscience®
has developed a highly sensitive and accurate diagnostic test on its high-throughput MassARRAY® System. This presentation will provide an overview of Agena Bioscience’s low-cost solution for SARS-CoV-2 testing.
12:55 Q&A
Cynthe Sims, PhD
HCLD (ABB), Technical Director, AdvaGenix
Dr. Cynthe Sims received a PhD in Chemistry from Texas Tech University where she was the recipient of numerous awards, notably, twice awarded National Science Foundation GK-12 Fellowship, SBC Chancellor’s Fellowship, and Provost’s Scholars Summer Award. Dr. Sims is a Board-Certified Clinical Laboratory Director- HCLD(ABB) with over 10 years of experience in both technical and management roles focusing on molecular diagnostics and precision medicine. She joined AdvaGenix in the spring of 2019 as Technical Director. She also serves as Laboratory Director for several domestic and international clinical laboratories. Dr. Sims participates in many professional and volunteer activities including service as a CAP volunteer inspector, CLSI guideline revision committees and as a mentor at San Diego State University. Originally from Texas, she has resided in San Diego, CA since 2012.
Brent Zanke, MD, PhD
Chairman and CMO, Arctic Medical Laboratories
Brent Zanke is a graduate of the Universities of Manitoba (MD, 1983) and Toronto (PhD, 1993) and a Fellow of the Royal College of Physicians of Canada with specialty certification in internal medicine and medical oncology. He conducted basic and translational laboratory-based research at the Ontario Cancer Institute before assuming administrative duties as Director of the Cross Cancer Institute in Edmonton, one of Canada’s two free standing cancer hospitals. He was the Provincial Head of Systemic Therapy for Cancer Care Ontario from 2002 until 2006. Dr. Zanke also leads the multi-site Ontario tumor bio-profiling initiative of the Ontario Cancer Research Network (www.ontariotumorbank.ca). This large-scale project is part of an ongoing bioinformatics effort to organize clinical outcome measures with biologic profiles of human tumors. He also conducts large-scale biomarker and genetic predictors of colon cancer risk having received funding from Genome Canada, the Canadian Cancer Society, and the Ontario Ministry of Research and Innovation. He is founder and Chairman of ArcticDx, a Canadian private molecular diagnostics company where he also fills the role of Chief Medical Officer.
Darryl Irwin, PhD
Vice President, Scientific Affairs, Agena Bioscience
Dr. Irwin has been leading the Scientific Affairs and Assays by Agena operations at Agena Bioscience (and its predecessor Sequenom, Inc.) in Asia Pacific, and more recently in a global capacity, for 12 years. Previously, Darryl led the genotyping division at the Australian Genome Research Facility. Darryl has also held positions at the Mater Laboratory Services, a hospital-based clinical genetics laboratory and Agen Biomedical, an immuno-diagnostics manufacturer. Darryl has a PhD from the University of Queensland in Non-Invasive Prenatal Testing (NIPT) and a BSc in Biotechnology from the Queensland University of Technology. Darryl has authored more than 20 publications, numerous book chapters, and holds several patents.