Arizona State University has been awarded a $12.5 million multiyear subcontract from the Frederick National Laboratory for Cancer Research (FNL), operated by Leidos Biomedical Research on behalf of the National Cancer Institute, to join the NCI’s Serological Sciences Network (SeroNet), the nation’s largest coordinated effort to study people’s immune response to COVID-19.
SeroNet was enacted as a result of $306 million in emergency supplemental funding from the U.S. Congress for the NCI to study serological sciences related to COVID-19.
ASU is one of just four Capacity Building Centers (CBCs) selected nationally for SeroNet. The goal is to develop high performance serological tests to determine a person’s previous exposure to SARS-CoV-2. The network aims to combat the ongoing COVID-19 pandemic by improving the ability to test for an antibody response to infection, especially among diverse and underserved populations, and to accelerate the development of treatments and vaccines aimed at preventing COVID-19 and improving patient outcomes.
“This award will now establish Arizona State University as the most comprehensive COVID testing research center in the Southwest, and is a testament to our commitment and scientific capabilities to be offered the opportunity to join SeroNet and to provide a critical service to our community and nation,” said ASU Biodesign Institute Executive Director Dr. Joshua LaBaer. “It builds upon the great successes of our innovative antibody testing platform, robust biomarker discovery and diagnostic assay development capabilities; our extensive experience at successfully completing large federal contracts, grants and FDA emergency use authorizations; and our response to this pandemic through large-scale PCR-based SARS-CoV-2 testing of saliva samples.”
The NCI, FNL and ASU were able to pivot to support COVID-19 research because of their deep experience in virology and immunology research, including research on viruses that cause cancer, such as HPV, and experience in immunotherapy.
In March, LaBaer, a medical oncologist by training who co-discovered breast cancer biomarkers included in a CLIA-approved breast cancer test with colleague Dr. Karen Anderson, shifted his laboratory to become a CLIA-certified clinical laboratory to fully support COVID-19 testing.
In May 2020, LaBaer and Vel Murugan, an ASU associate research professor and co-principal investigator on the SeroNet CBC subcontract, created the first saliva-based COVID-19 test in the Western United States.
To date, ASU has provided more than 300,000 free saliva tests to the general public, first responders, doctors, nurses and medical personnel, and the entire ASU community to help Arizona in the response to keep individuals safe and healthy during the pandemic.
As part of the national SeroNet, ASU’s interdisciplinary team of expert scientists and researchers at the Biodesign Institute, led by LaBaer, will establish the ASU Biodesign Capacity Building Center (ABCBC). Other key individuals involved in this project are Ji Qiu, Jin Park, Femina Rauf, Lusheng Song, Mitch Magee and Michael Fiacco.
“Through this latest project, we hope to develop a simple, FDA-approved COVID-19 antibody test to detect for previous SARS-CoV-2 exposure and to better understand a person’s immune response to COVID-19,” said LaBaer. “We ultimately want to develop a test for any exposures people may have had to all known human coronaviruses and other respiratory pathogens in order to improve patient outcomes.”
The core of the technology builds upon a novel ASU platform (called MISPA) that uses rapid DNA sequencing to monitor many patients’ immune responses to multiple viral proteins simultaneously, via a molecular “barcoding.” ASU has tested the platform on cancer subtypes caused by HPV. Now, they want to adapt the same technology for understanding COVID-19.
“This system exploits the power of DNA next-generation sequencing (NGS) technology to quantify COVID virus antigens and their interactions with antibodies produced in the body to fight the infection,” said Murugan. “With this assay, we 'barcode' individual proteins called antigens within the virus with unique DNA sequences that interact in solution with patient serum, followed by quantification of the antibody-bound barcodes by NGS.”
Unlike current commercially available serological tests, the MISPA-based test is designed to be quantitative about the strength of the immune response while providing information about responses to multiple proteins and eventually, multiple viruses simultaneously. In addition, because individual reactions can also be indexed (or barcoded) in parallel, thousands of patient samples can be combined, and all the results determined in a single NGS run (many barcoded patients versus many barcoded proteins).
“MISPA will also be deployed through a similar high-throughput, fully automated test that can process thousands of samples per day as we have successfully demonstrated from our COVID-19 saliva test,” said Murugan.
Initial tests will rely on a testing pool of individuals who have recovered from the infection. Potential sites for serological tests include: ValleyWise, Midwestern/Abrazo hospital networks, Dignity Health hospital network, Columbia University, Colorado River Indian Tribal community through their tribal government, ASU students and population, other universities in Arizona and essential infrastructure partners.
Should the test validation and FDA EUA become approved, testing will expand to essential infrastructure employees, health care professionals and residents in long-term care facilities or other congregate living settings, including prisons and shelters. Community surveillance for asymptomatic population will be conducted at a lower priority when needed.
The lessons learned from ASU’s role in SeroNet research could be applied immediately to the COVID-19 pandemic crisis and may prove valuable to public health beyond the pandemic.