Virginia Policy Review 87
Covid Testing: Notes from the Frontline and Thoughts for the Future By David B. Walek Abstract As Vice President and General Counsel of Veritas Genetics, a whole genome diagnostic sequencing company, David B. Walek has an inside view of the medical and legal challenges at play in the COVID-19 crisis. Veritas was co-founded by George M. Church, a widely acclaimed geneticist, chemist, and molecular engineer, who serves as the Robert Winthrop Professor of Genetics at Harvard Medical School and as a Professor of Health Sciences and Technology at Harvard and MIT. In response to the pandemic, Veritas has temporarily shifted all of its work to COVID-19 testing, utilizing both molecular and antibody tests. The company’s customers range from individuals, schools, pharmacies, and nursing facilities to ski resorts, AMC, and Netflix. Here, Walek provides an account of his own experiences, insights, breakthroughs, and concerns, as well as a number of action items, policy considerations and objectives, and lessons. Looking Back The COVID-19 pandemic has brought unprecedented attention to the, until now, relatively low-profile, research-oriented world of genetic laboratories. Until the Spring of 2020, genetic laboratories primarily served the needs of academic research, drug development, biotechnology, and advanced genetic screening for serious specialized medical risks and conditions. The laboratories themselves were, and are, heavily regulated and highly technical, managed and staffed by highly trained lab managers and technicians, and full of expensive and sophisticated sequencing machines and related equipment, built to operate at extraordinary speed and precision. Public awareness of the field was, for the most part, limited to occasional media and pop culture references, along with the marketing of a handful of consumer-facing gene scanning companies that were limited to providing ancestral data and only a few basic genetic medical markers because they operated outside the traditional medical world. In the face of a sudden and overwhelming need to test enormous numbers of individuals for the COVID-19 virus, genetic laboratories immediately set aside their existing core businesses or academic missions. With the recognition that genetic screening offered the most accurate method of detecting the presence of the virus, laboratories pivoted as rapidly as possible to all COVID testing, all the time. While the attention of the public and the media was quite understandably focused almost exclusively on the availability and delivery of COVID testing, the issues and challenges faced by the genetics labs and their partners were complex and multidimensional. These challenges included:
