METADATA last updated: 2026-03-05 by BA file_name: Anne Wyllie Nomination for FDA Foundation 2022 Innovations in Regulatory Science Awards.md file_date: 2022-06-03 title: Anne Wyllie Nomination for FDA Foundation 2022 Innovations in Regulatory Science Awards category: regulatory subcategory: open-euas tags: source_file_type: gdoc xfile_type: docx gfile_url: https://docs.google.com/document/d/16muU80i9sAFPsCQNosyrK6ZYJqMPxf0gSqZcsudqYZM xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/open-euas/Anne%20Wyllie%20Nomination%20for%20FDA%20Foundation%202022%20Innovations%20in%20Regulatory%20Science%20Awards.docx pdf_gdrive_url: https://drive.google.com/file/d/1w5MajWqU_1w4aIgNZJ3HKzbzlzGAc9tB pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/open-euas/Anne%20Wyllie%20Nomination%20for%20FDA%20Foundation%202022%20Innovations%20in%20Regulatory%20Science%20Awards.pdf conversion_input_file_type: docx conversion: pandoc license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ tokens: 1428 words: 1034 notes: summary_short: The Reagan-Udall Foundation nomination argues that Anne Wyllie’s SalivaDirect EUA pioneered an “open source protocol” model by validating saliva and extraction-free processing while disclosing components and qualifying multiple reagent/instrument options for broad CLIA lab adoption. It highlights the FDA “designation” approach, legal and operational infrastructure for scaling a lab network, and downstream effects such as supply-chain resilience and industry-wide cost compression in molecular testing. The nomination frames SalivaDirect as a template for “generic” diagnostics authorization with relevance to future pandemic preparedness, while disclosing FloodLAMP’s advisory relationship to Wyllie. CONTENT ***INTERNAL TITLE:*** Nomination for the Reagan-Udall Foundation Innovation in Regulatory Science Award June 3, 2022 The FDA called it the most unusual submission they had ever received. They were referring to the EUA for the SalivaDirect SARS-CoV-2 RT-PCR Test EUA, developed by Anne Wyllie and a small, dedicated team at the Yale School of Public Health. Dr. Wyllie, working with Professor Nathan Grubaugh, pioneered innovations on several different fronts of diagnostic testing, by 1) validating saliva as an excellent specimen type for a respiratory virus, 2) omitting the gold standard RNA extraction step, and with it a significant cost and supply chain vulnerability, and 3) creating the first "open source protocol" EUA. For the latter "ground breaking" "game changing"^1^ contribution to the field of regulatory science, we nominate Dr. Anne Wyllie for the Reagan-Udall Foundation's 2022 Innovation Award. What made the SalivaDirect EUA so unusual is that Dr. Wyllie and her team submitted for an IVD EUA even though they never intended to manufacture and sell test kits. Normally university labs submit for LDT EUAs which are inherently limited to a single clinical lab, or affiliated lab network. Dr. Wyllie understood that to have a large impact, their test would need to be available to all CLIA labs, as is the case for commercial molecular diagnostic test kits. Working with 2 former FDA reviewers, they came up with a multifaceted creative solution. First, they bucked the almost universal proprietary approach in the diagnostics industry by not patenting their test. Next they chose the open access CDC primers, configuring them into a convenient duplex format. Further they fully disclosed the ingredients of their test and crucially validated multiple suppliers of all 3 components: the primers, proteinase K, and PCR master mix, along with multiple qPCR instruments. To appreciate the significance of the SalivaDirect EUA, it is important to understand that the FDA does not authorize or approve protocols, only "test systems". The specimen type, exact reagents and the particular step-by-step procedures must be fully specified, along with all validated instruments. It was a lot of work for the team to validate the different combinations, but this created supply chain redundancy at a time in the pandemic when it was sorely needed. It also created plug-and-play capability that is unique in the field outside the CDC EUA. When our lab ordered the reagents for SalivaDirect, all came within 24 hours due to the commercial relationships setup by Wyllie and team. The thoughtful development of commercial support was coupled with a focus on simplicity. The "Direct" in the test name refers to the elimination of the RNA extraction/purification step. "Think about SalivaDirect. To do an RNA assay without RNA extraction - pretty creative. Cuts off an hour and a ton of time and money. Nobody would have even said that was possible. Don't even think about it." (9-12-2021 Mara Aspinall, advisor to Rockefeller Foundation and National Testing Action Plan). Our novice lab technician had never done PCR and was able to independently run SalivaDirect with success on her first try. That is a testament to this well designed, well vetted test protocol. On August 15, 2020 the FDA embraced the new and innovative "open source protocol," issuing a press release along with the authorization. The FDA created a new "designation" process for the SalivaDirect team to authorize CLIA labs to use the EUA. The designation process was greatly streamlined over labs doing their own LDTs. Wyllie led the establishment of standard legal contracts for different types of labs, including state-wide contracts, to further facilitate expansion of access to the test. This is just one example of the hard work done outside the lab under the leadership of Wyllie that has led to the tremendous success of SalivaDirect. Other notable efforts include a weekly meeting for designated labs, an email newsletter, conference appearances, website buildout, and coordination with other testing groups such as the gLAMP consortium. The impact of Dr. Wyllie's work and SalivaDirect has been far reaching. Perhaps the most significant practically has been the opening up of far greater access to low cost testing. The cost of goods for the SalivaDirect test is $2-3/test, when in 2020 and through much of 2021, typical kits cost in excess of $20 even in large volumes. Mark Roth, CEO of Lighthouse Lab Services, stated that SalivaDirect singlehandedly cause cost compression in the entire industry. Because the test wasn't patented and the protocol was openly disclosed, many CLIA labs created their own "extraction-less" saliva tests during the year long window when HHS removed the FDA's oversight of LDTs. We estimate that the number of such copycat tests done outside of the SalivaDirect EUA is an order of magnitude or more greater than those done by designated labs. The SalivaDirect lab network has grown to 170 labs in 41 states, performing millions of tests and saving many lives during the pandemic. They have shown what's possible with innovation, coordination, and perseverance. Dr. Wyllie has led the successful addition of 24 amendments to the SalivaDirect EUA over almost 2 years, including commercial partnerships for OTC at home collection, sample pooling, and a large assortment of instruments. SalivaDirect has gone international, advocating for effective COVID testing and helping to get similar tests authorized in low and middle income countries around the world. Dr. Wyllie has spearheaded a new paradigm of regulatory authorization, pioneering what can be thought of as the generics of diagnostics. She created a pathway for labs to easily and directly access large volume reagent suppliers, while building the framework to manage those suppliers and the labs under current FDA regulations. FDA leadership has expressed that open source protocol EUAs have strong potential for future pandemics. Anne Wyllie has been a true innovator in creating the template for open source protocol tests and blazing the trail in low cost, accessible diagnostics when they were needed most. DISCLOSURE: Dr. Wyllie is a scientific advisor to FloodLAMP Biotechnologies, a public benefit corporation. FloodLAMP has submitted tests to the FDA as open source protocol EUAs. 1. [FDA Press Release - Aug 15, 2020](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-yale-school-public-health) FLOODLAMP ARCHIVE FILE PATH: regulatory/open-euas/2020-08-15_FDA Website - Press Release FDA Issues EUA for SalivaDirect.md Sincerely, Randy True CEO, FloodLAMP Biotechnologies, PBC