Dr. Pestano is currently is the Chief Development Officer at Biodesix, a leading liquid biopsy molecular diagnostics company. He also serves as the NYS Laboratory Director of the company’s certified laboratory. His experiences have focused on assay development of molecular diagnostics in oncology and in virology, with emphasis on liquid and tissue biopsies.

Dr. Pestano is the co-inventor on multiple patents, most recently for a device used for blood collection and plasma separation. He has also fostered many collaborations in the biotechnology industry - including with Bio-Rad on the development of novel ddPCR assays intended for use in the Biodesix centralized, clinical testing laboratories in the United States.

Rapid Deployment of a New COVID-19 ddPCR Assay in a Centralized CLIA Testing Laboratory in the United States

The availability of COVID-19 molecular testing is limited around the globe. Most assays for respiratory specimens utilize a variety of swabs, viral inactivation methods and qPCR. Here we describe the rapid development and deployment of a novel Droplet Digital PCR (ddPCR) as a complement to commonly available qPCR. The availability of the ddPCR assays not only provides additional kits in the COVID-19 testing arena but also has been shown to be a more sensitive technology to qPCR in early and recovering COVID-19 cases. The Biodesix® SARS-CoV-2 ddPCR™ Test is currently under FDA EUA review and is available for testing in the CLIA Laboratory. Specifically, this test is a single tube - triplex assay that detects two regions of the SARS-CoV-2 N gene (N1 and N2) and a human RNase P gene control. We will present on the development and validation of the test as well as on its performance in field testing of Tier 1 patients.

• ddPCR provides sensitive detection and specific detection of COVID-19
• Rapid development and deployment of a CLIA ready ddPCR assay for COVID-19 is possible

Dr. Qian Liang is currently a R&D lead of POCT department at Jiangsu Bioperfectus Technologies Co., Ltd – a Chinese STAR market listed firm focusing on molecular diagnosis technologies. Dr Liang obtained his Ph.D. degree in BioMEMS and microfluidics from Nanyang Technological University. Prior to starting his appointment at Bioperfectus, he was staff engineer at Bio-Rad Laboratories and senior research scientist and R&D team lead at Delta Research Centre. He has more than 10 year experience in medical device, fluidic chip as well as In Vitro Diagnostic (IVD) POCT products development. He was the author and co-author of 1 book chapter, 20 international journal and conference articles. He was also the inventor of more than 20 patents.

In the first quarter of 2020, people all over the world have witnessed the explosive spread of COVID-19 pandemic. As a new coronavirus for human beings, vaccine development and optimization of therapeutic schemes are still in progress. At current stage, the most effective measures to control and prevent the COVID-19 pandemic suggested by healthcare experts is to diagnose and isolate infected patients at early stage. Real-time PCR technology, being well acknowledged as “gold standard”, is widely adopted by most of countries for COVID-19 detection.

However, recent clinical studies reported significant numbers of false negative cases due to the limitation of RT-PCR and huge patient population. We carried out laboratory study to detect the SARS-CoV-2 virus by using both RT-PCR and droplet digital PCR platforms. It is found that the overall accuracy of droplet digital PCR platform is much superior to RT-PCR, with a lower limit of detection of 2 copies/mL. We further reviewed the data collected from clinical trial of Bioperfectus COVID-19 coronavirus real-time PCR kit and analyzed discrepant cases and their clinical history. As a supplementary method to RT-PCR technology, It is suggested that droplet digital PCR will serves as an important tool for suspected cases diagnosis when RT-PCR results fall into gray zone and discharge standard for in-patient after treatment.

• Overall accuracy of dPCR is much superior to RT-PCR
• dPCR technology can helps to identify suspected cases when RT-PCR is not able to confirm/exclude 
• dPCR results can be used as one of discharge standards

Deborah is a Senior Scientist at Tessa Therapeutics where her work focuses on developing and qualifying molecular assays for characterization or lot release of Tessa's cell therapy products targeting a wide range of cancer indications. Before joining Tessa, Deborah worked at MSD, where she utilized her diverse experience in genetics and genomics to identify novel targets and to validate exploratory and clinical biomarkers across different therapeutic areas. Deborah holds a Ph.D. in Molecular Microbiology and Microbial Pathogenesis from Washington University in Saint Louis (USA).

Dr Edmund Ang is currently a Principal Scientist with MERCK BioReliance® Biosafety Testing Services providing scientific and technical support and thought leadership on biologics safety testing to biopharma in the Asia Pacific region. He has extensive life science research and development experiences from both academic and industrial settings. He obtained his PhD in Cell Biology from the University of Edinburgh, Scotland, UK, followed by postdoctoral research on cell signalling at Stanford University, California, USA, and at the National Cancer Centre Singapore, before joining Ionis Pharmaceuticals and Eli Lilly working on cancer drug and biomarker discovery programs. He also has commercial experience with biotech companies including Roche Diagnostics and Thermo Fisher Scientific in the areas of cellular analysis, applied markets and bioproduction.

As a global biosafety testing service provider, we are constantly working on applying better detection methods to advance biosafety testing of biologics. In recent years, we have developed, validated and introduced several GMP assays based on ddPCR technology for key applications including the determination of copy number of integrated transgenes in production cells and genomic titer of viral vector, which are important quality control measures for recombinant protein and cell gene therapies. In this presentation, we will share our experiences with these ddPCR assays and where relevant versus the QPCR counterparts that are still the more conventional methods in use thus far, and highlight important implication and impact with the use of ddPCR assay to provide a more accurate and precise absolute quantification of target sequence.

The research of Dr Schuuring focuses in the last 3 decades on the identification of prognostic/predictive epigenetic and molecular markers for clinical outcome, response to chemo-radiotherapy, gene-targeted therapy and treatment-resistance in lung, GIST, head&neck cancer, as well as the early detection of cervical cancer in scrapings. More recently his interest expanded to monitoring plasma ctDNA as a bloodborne-based molecular tool to predict response to targeted and immuno-therapy using ddPCR and ctNGS. He is heading the laboratory of Molecular Pathology offering the latest innovative methods for treatment-decision-making in the region North-Netherlands. Since 1997 he is active in (inter)national committees and advisory boards on implementing Molecular Pathology, the organisation of international proficiency mutation testing in lung tissue biopsies and plasma ctDNA, and co-authored various international guidelines on Molecular Pathology. He graduated in Medical Biology, holds a PhD in Molecular Biology (University of Amsterdam) and is trained as a clinical scientist in Molecular Pathology. He has authored more than 230 publications in leading scientific journals.

Circulating tumor DNA to monitor tumor response in lung cancer patients treated with immunotherapy

A significant minority of lung cancer patients treated with immune checkpoint inhibitors shows durable responses but no adequate biomarkers are available for predicting which patients will benefit. Immunotherapy is expensive and potentially toxic. Tumor response is monitored by tumor volume using CT scanning. The aim of our study is to assess plasma levels of non-targetable tumor-specific mutations as molecular biomarkers and monitoring tool for durable responses to immunotherapy in advanced NSCLC

• Decrease in KRAS/BRAF specific ctDNA levels using ddPCR during immunotherapy predicts early and durable tumor response in NSCLC
• Monitoring of ctDNA during treatment with immunotherapy is a promising approach to predict tumor response
• Predictive molecular profiling using liquid biopsies is a feasible, less-invasive and promising new method in Molecular Diagnostics of Lung Cancer

Dr. Paweletz is head of the Translational Research Laboratory (TRL) of the Belfer Institute for Applied Cancer Science at Dana Faber Cancer Institute in Cambridge, Massachusetts. He joined from Merck & Co., Inc., where he most recently served as principal scientist, externalization lead, and proteomics site lead for the Department of Molecular Biomarkers at the Merck Research Laboratory in Boston.

At Merck, Dr. Paweletz successfully built platforms to look at disease biomarkers in body fluids and oversaw research activities spanning the spectrum from early-stage discovery to the clinic. Prior to that, he was a postdoctoral fellow in the Department of Physiology at the Uniformed Services University School of Medicine in Bethesda, Maryland and a research fellow in the Laboratory of Pathology at the National Cancer Institute, National Institutes of Health (NIH). Dr. Paweletz earned his PhD with honors from Georgetown University and his Bachelor of Science Degree from Baldwin Wallace College.