FDA Approves Cue Health’s Point-of-Care COVID-19 Test Using Nasal Swabs

What You Should Know:

– The Food and Drug Administration (FDA) has awarded Cue Health Emergency Use Authorization (EUA) for its rapid, portable, molecular point of care COVID-19 test.

– The company recently raised $100M in Series C funding from Menlo Park-based Decheng Capital, Foresite Capital, Madrone Capital Partners, Johnson & Johnson Innovation – JJDC, Inc., ACME Capital, and other investment firms.

Cue Health Inc.
(“Cue”), a healthcare
technology company, announced today that it has received Emergency Use
Authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) for
the company’s rapid, portable, point-of-care COVID-19 test. The Cue COVID-19
Test is a molecular test that detects the RNA of SARS-CoV-2, the virus that
causes COVID-19, in 25 minutes using a nasal swab sample taken from the lower
part of the nose.

How It Works

Cue’s COVID-19 test runs on the compact and portable Cue Health Monitoring System. A single-use COVID-19 test kit includes a Sample Wand and COVID-19 Test Cartridge. The system performs rapid molecular analysis at the point-of-care and transmits test results to the Cue Health App on a connected mobile device. The current FDA EUA allows the Cue COVID-19 test to be used anywhere under the supervision of qualified medical personnel. The company is intending to seek additional FDA authorizations for use of the COVID-19 test in settings such as the workplace, schools, and at home.

Emergency Use Authorization Status

The Cue COVID-19 Test has not been FDA cleared or
approved. The test has been authorized by the FDA under an EUA for use by
clinics and laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (“CLIA”), 42 U.S.C. § 263a, to perform diagnostic tests. The
test has been authorized only for the detection of RNA from SARS-CoV-2 virus
and diagnosis of SARS-CoV-2 virus (COVID-19) infection, not for any other
viruses or pathogens.

The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of SARS-CoV-2 virus under section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is extended, terminated or revoked sooner.

This project has been funded in whole or in part with
federal funds from the U.S. Department of Health and Human Services;
Office of the Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, under Contract No.
HHSO100201800016C.

Future Plans

Cue plans to initially launch its COVID-19 test with
select leading healthcare institutions and their satellite centers, followed by
nationwide...