Uh-Oh Labs 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 Uh-Oh Labs 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-LoopTM 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, Uh-Oh Labs 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 Uh-Oh Labs

Uh-Oh Labs is a California-based diagnostics and health tech company with a mission to improve public health by developing affordable and accurate diagnostics. Uh-Oh Labs is developing tests through the proprietary Loop-de-LoopTM platform which enables simplicity, speed, and lower costs while providing accurate, lab-grade results. Additionally, Uh-Oh Labs is partnering with other members of the healthcare ecosystem to expand access of lab-grade diagnostics and improve the delivery of care. Uh-Oh Labs has received Emergency Use Authorization for the UOL COVID-19 Test and is developing tests for other indications including flu, STIs, and diagnostic biomarkers. Uh-Oh Labs 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.

For more information, visit us at uhohlabs.com