Scout announces FDA Authorization of the UOL COVID-19 Test for Point-of-Care
Molecular diagnostics company Uh-Oh Labs has received an emergency use authorization (EUA) from the Food and Drug Administration (FDA) for the UOL COVID-19 Test for use at the point-of-care with customers who have a CLIA Waiver, Certificate of Compliance, or Certificate of Accreditation. The UOL COVID-19 Test is a nucleic acid amplification test which allows for detection of SARS-CoV-2 RNA down to 400cp/swab within 40 minutes. In a clinical study, the UOL COVID-19 Test demonstrated a 96.1% overall agreement with an EUA authorized high-sensitivity RT-PCR assay, no false positives, and detected 97.9% of SARS-CoV-2 positive samples, excluding those with very low levels of virus.
The UOL COVID-19 Test is comprised of a reusable Instrument, disposable Test Kits, and a mobile Dx Pro iOS app. The UOL COVID-19 Test has been designed to simplify sample collection, running the assay, and result interpretation. The UOL COVID-19 Test has also been engineered specifically to lower per-test cost by leveraging the proprietary Loop-de-Loop platform. An assay can be started within 5 minutes, including sample collection and patient registration, and then runs 40 minutes “hands off”, allowing for a streamlined workflow. The results are then viewable on the Dx Pro app with plain language results, removing the need to interpret lateral flow lines.
The UOL COVID-19 Test production is already underway and available for purchase from qualified customers who have a CLIA Waiver, Certificate of Compliance, or Certificate of Accreditation. Additionally, UOL is actively working towards an EUA for the UOL COVID-19 Test for non-prescription, non-laboratory use.
Uh-Oh Labs has been supported with over $15M in contracts from the National Institutes of Health as well as investments from private investors such as Y Combinator.
View the Letter of Authorization, as well as relevant documents for the UOL COVID-19 Test, on the FDA’s website.
About UOL
Uh-Oh Labs (UOL) is a California-based diagnostics and health tech company with a mission to improve public health by developing affordable and accurate diagnostics. UOL is developing tests through the proprietary Loop-de-Loop platform which enables simplicity, speed, and lower costs while providing accurate, lab-grade results. Additionally, UOL is partnering with other members of the healthcare ecosystem to expand access of lab-grade diagnostics and improve the delivery of care. UOL has received Emergency Use Authorization for the UOL COVID-19 Test and is developing tests for other indications including flu, STIs, and diagnostic biomarkers. UOL has been funded in part by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative, as well as funding from private investors including Y Combinator.
