TY - JOUR
T1 - The Clinical Review Committee
T2 - Impact of the Development of in Vitro Diagnostic Tests for SARS-CoV-2 within RADx Tech
AU - Robinson, Matthew
AU - Gaydos, Charlotte
AU - Van Der Pol, Barbara
AU - McFall, Sally
AU - Hsieh, Yu Hsiang
AU - Clarke, William
AU - Murphy, Robert
AU - Widdice, Lea
AU - Hirschhorn, Lisa
AU - Rothman, Richard
AU - Achenbach, Chad
AU - Hawkins, Claudia
AU - Samuta, Adam
AU - Gibson, Laura
AU - McManus, David
AU - Manabe, Yukari
N1 - Publisher Copyright:
© 2020 IEEE.
PY - 2021
Y1 - 2021
N2 - The NIH Rapid Acceleration of Diagnostics (RADxSM) Tech Program was created to speed the development, validation, and commercialization of innovative point-of-care (POC) and home-based tests, and to improve clinical laboratory tests, that can directly detect SARS-CoV-2. Leveraging the experience of the Point-of-Care Technologies Research Network, a Clinical Review Committee (CRC) composed of clinicians, bioengineers, regulatory experts, and laboratorians was created to provide structured feedback to SARS-CoV-2 diagnostic innovators. The CRC convened 53 meetings with 49 companies offering SARS-CoV-2 tests in POC and reference laboratory formats as well as collection materials. The CRC identified common barriers to device design finalization including biosafety, workflow, result reporting, regulatory requirements, sample type, supply chain, limit of detection, lack of relevant validation data, and price-performance-use mismatch. Feedback from companies participating was positive.
AB - The NIH Rapid Acceleration of Diagnostics (RADxSM) Tech Program was created to speed the development, validation, and commercialization of innovative point-of-care (POC) and home-based tests, and to improve clinical laboratory tests, that can directly detect SARS-CoV-2. Leveraging the experience of the Point-of-Care Technologies Research Network, a Clinical Review Committee (CRC) composed of clinicians, bioengineers, regulatory experts, and laboratorians was created to provide structured feedback to SARS-CoV-2 diagnostic innovators. The CRC convened 53 meetings with 49 companies offering SARS-CoV-2 tests in POC and reference laboratory formats as well as collection materials. The CRC identified common barriers to device design finalization including biosafety, workflow, result reporting, regulatory requirements, sample type, supply chain, limit of detection, lack of relevant validation data, and price-performance-use mismatch. Feedback from companies participating was positive.
KW - COVID-19
KW - Rapid Acceleration of Diagnostics program
KW - SARS-CoV-2
KW - in vitro diagnostics
KW - point-of-care testing
UR - http://www.scopus.com/inward/record.url?scp=85120346438&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85120346438&partnerID=8YFLogxK
U2 - 10.1109/OJEMB.2021.3070818
DO - 10.1109/OJEMB.2021.3070818
M3 - Article
C2 - 34192285
AN - SCOPUS:85120346438
SN - 2644-1276
VL - 2
SP - 138
EP - 141
JO - IEEE Open Journal of Engineering in Medicine and Biology
JF - IEEE Open Journal of Engineering in Medicine and Biology
M1 - 9418532
ER -