Using CRISPR Genome Editing to Make Cyanide-Free Cassava - Innovative Genomics Institute (IGI)

The appearance and spread of the novel severe acute respiratory syndrome coronavirus (SARS-CoV-2) led to the official declaration of a global pandemic, with states in the US implementing shelter-in-place orders at an unprecedented scale. SARS-CoV-2 has a robust person-to-person transmission rate and an asymptomatic period of two weeks or more, leading to widespread infection that has overwhelmed healthcare infrastructures around the globe. Effective public health measures require extensive, accurate, and rapid testing to determine infection rates. Here we describe the strategy we used to establish a CLIA-licensed clinical laboratory to perform a validated Laboratory-Developed Test (LDT) for SARS-CoV-2 in Berkeley, California and the surrounding Bay Area community. Our procedures for implementing the technical, regulatory, and data management workstreams necessary for clinical sample processing provide a roadmap to aid others in setting up similar testing centers. Note on Nomenclature in accordance with established virology and infectious disease nomenclature, throughout this document we use “SARS-CoV-2” to refer to the viral agent causing infection and “COVID-19” to refer to the human infectious disease caused by that viral agent . ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement IGI Founders Fund, Dr. Anders Naar, Rick and Rachel Klausner, and the Shurl and Kay Curci Foundation ### Author Declarations All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript. Yes All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data are available in figures, supplemental files and linked materials. <https://innovativegenomics.org/sars-cov-2-testing-guide/> * ### Commonly-Used Abbreviations FDA : Food and Drug Administration CDC : Centers for Disease Control and Prevention CMS : Centers for Medicare & Medicaid Services CDPH : California Department of Public Health LFS : Laboratory Field Services (division of CDPH that regulates CLIA) LDT : Laboratory-Developed Test CLIA : Clinical Laboratory Improvement Amendments EUA : Emergency Use Authorization (under FDA) RT-qPCR : Quantitative Reverse Transcription Polymerase Chain Reaction LIMS : Laboratory Information Management System

The city is partnering with LifeLong Medical Care to reach people at risk. A new lab at UC Berkeley can process the tests in 24 hours.

As the government fumbled Covid-19 testing, researchers at UC Berkeley's Innovative Genomics Institute stepped up—with their own time and funding.