RADx-UP: Return To School Diagnostic Testing Approaches

Rapid Acceleration of Diagnostics (RADx)Goal: Rapidly scale-up testing across the country and enhance access to those most in need

Project Description

RADx Tech Highly competitive, rapid three-phase challenge to identify the best candidates for at-home or point-of-care tests for COVID-19.

RADx-Advanced Technology Platforms

(RADx-ATP)

Rapid scale-up of advanced POC technologies and laboratories to accelerate, enhance and validate utility of ultra-high throughput machines and facilities.

RADx-Radical(RADx-rad)

Develop and advance novel, non-traditional approaches or new applications of existing approaches for testing.

RADx-UnderservedPopulations (RADx-UP)

Interlinked community-engaged projects focused on implementation strategies to enable and enhance testing of COVID-19 in underserved and/or vulnerable populations.

RADx-UP Return to School Diagnostic Testing ApproachesBudget: $50M Total; $33M recommended for funding in R2S Phase I

Goal: Develop and test COVID-19 diagnostic testing approaches to safely return children and staff to the in-person school setting in underserved and vulnerable communities

Mechanism: Other Transaction Authority to provide flexibility for changing circumstances and funding of non-traditional partners

• Focus on children and adolescents below the age eligible for vaccination via Emergency Use Authorization; include children through high school based on timing of award and rates of vaccination in the community

• Advance methods to integrate testing in return to or maintenance of in-person instruction

• Identify effective, scalable, and sustainable testing implementation strategies, including in-school testing, in community pediatric primary care clinics, childcare centers, preschool, and school settings serving primarily underserved or disadvantaged children and their families.

Program PhasesPHASE I PHASE II

Opportunity Number OTA-21-004 OTA-21-007

Total Direct Costs Per Year ~$5M $3-5M

Eligibility Targeted solicitation Invitees selected from LOI

Number of Awards 8 TBD

Award Start Date April 15, 2021 June 30, 2021

Scientific Focus

Data on COVID-19 testing and mitigation strategies, including community engagement and education, to inform safe return to school in Fall of 2021

Data on COVID-19 testing and mitigation strategies, including community engagement and education, based on changing guidance for Fall of 2021

• Projects cover a range of settings including public, charter, tribal, early education, and special education schools

• Children range in age from 3-17 years, with the majority of projects covering children from 6-17 years of age

• Critically, these projects include children with medical complexity or intellectual or developmental disabilities who may not be able to use other mitigation strategies

Phase I Projects

Phase II Scientific Goals

• Address the impact of vaccine availability for school personnel and students ages 12 and older; include efforts to increase vaccine confidence

• Provide information on circulating variants and breakthrough infections following vaccination

• Increase the reach of the research in racial and ethnic groups not included in applications funded in Phase I

• Ensure coverage of early education or preschool cohorts and specific strategies for testing and mitigation in this population

• Focus on increasing the geographic areas covered to understand regional variation in mitigation strategies and to increase the number of projects in dense, urban areas or hard to reach rural areas

Phase II Timeline

MAR

03.26Publish NOITP

MAY

05.14Receipt Date for Full Applications

05.19Hold Reviewer Orientation Webinar

05.25Hold Scientific Review Meeting

04.21Hold LOI Review Meeting

04.23Publish ROAEmail ROA to Investigators

APR

04.01Hold LOI Webinar

04.29Hold ROA Webinar

04.16Receipt Date for LOI

JUL

TBDHold Kick-off Meeting

JUN

06.07Send RFNs to Investigators

06.09Obtain Leadership Approval for Funding Plan

06.30Execute Awards

RADx-rad: PreVAIL kIds (Predicting Viral-Associated Inflammatory disease severity in children with Laboratory diagnostics and artificial Intelligence)

Rapid Acceleration of Diagnostics (RADx)Goal: Rapidly scale-up testing across the country and enhance access to those most in need

Project Description

RADx Tech Highly competitive, rapid three-phase challenge to identify the best candidates for at-home or point-of-care tests for COVID-19.

RADx-Advanced Technology Platforms

(RADx-ATP)

Rapid scale-up of advanced POC technologies and laboratories to accelerate, enhance and validate utility of ultra-high throughput machines and facilities.

RADx-Radical(RADx-rad)

Develop and advance novel, non-traditional approaches or new applications of existing approaches for testing.

RADx-UnderservedPopulations (RADx-UP)

Interlinked community-engaged projects focused on implementation strategies to enable and enhance testing of COVID-19 in underserved and/or vulnerable populations.

C. MICHIGAN UNIVERSITY

CONN. CHILDREN’S

MEDICAL CENTER

UC SAN FRANCISCO

JOHNS HOPKINS

UNIVERSITY

UC SAN DIEGO

BAYLOR COL. OF MEDICINE

Severity predictors integrating salivary transcriptomics and proteomics with neural network intelligence in SARS-CoV-2 infection in childrenUsha Sethuraman

Predicting Viral-Associated Inflammatory disease severity in children with Laboratory diagnostics and artificial Intelligence

COVID-19 Network of networks expanding clinical and translational approaches to predict severe illness in childrenLawrence Kleinman

Artificial Intelligence COVID-19 Risk Assessment for kidsAnanth V. Annapragada

Diagnosing and predicting risk in children with SARS-CoV-2 related illnessJane Burns Data science approach to MIS-C

identification and management associated with SARS-CoV-2 infection and Kawasaki Disease in childrenCedric Manlhiot

Identifying biomarker signatures of prognostic value for MIS-CJuan Salazar

Discovery and clinical validation of host biomarkers of disease severity and MIS-C in children with COVID-19Charles Chiu

Diagnosis of MIS-C in febrile childrenAudrey R. Odom John

CHILDREN’S HOSP. OF

PHILIDELPHIA

RW JOHNSON MEDICAL SCHOOL

UC SAN DIEGOLucila Ohno-Machado

• 8 Teams w/ multi-disciplinary expertise to address Program aims

• Access to diverse patient populations in > 75 sites across 30 US States

• International collaborations in UK, Canada, Asia, & S. America

• Enrolling >16,000 children with substantial racial and ethnic diversity

• Leveraging established biorepositories

39 Sites With Participants

Asymptomatic/Mild 11,778

Moderate-Severe 689

MIS-C 405

KD 164

Questions?