POCT for COVID19, Influenza and RSV

Award type :
Product Development Award

Product type :
Diagnostics

Award year :
2022

Project start date :
11 / 30 / 2023

Project end date :
01 / 30 / 2026

Project duration (months) :
26

Development stage :
Late Validation, Clinical Validation, Regulatory approval

Target disease :
Respiratory (COVID-19, flu, RSV)

Region served :
World

Recipient organization / Country of funding recipient organization :
SD Biosensor / Republic of Korea

Collaborator(s) / Country :
Program for Appropriate Technology in Health (PATH) / USA

Funding amount(KRW) :
1,780,575,294

This project aims to develop and evaluate the performance and usability of the STANDARD™ M10 system, a versatile molecular diagnostic platform suitable for decentralized, near-patient settings. The focus is on developing a multi-target RT-PCR-based Flu/RSV/SARS-CoV-2 Fast cartridge, designed to deliver rapid and accurate diagnostics for critical respiratory diseases. In this project, data on analytical, clinical, and user performance will be generated to support submissions to Stringent Regulatory Authorities. This product’s suitability for use in near-patient settings by minimally trained operators, ability to eliminate the need for external computing, and capability to run cartridges for various health conditions on a single machine will help enhance the availability of accurate molecular diagnostics for high-risk populations in LMICs.