19 January 2021 - - US-based medical diagnostic products provider Cue Health Inc's molecular, point-of-care COVID-19 Tests are being distributed to five additional states, including Colorado, Minnesota, Pennsylvania, Rhode Island and Utah, as part of the joint USD 481m program with the US Department of Health and Human Services and the Department of Defense, the company said.

This expansion doubles the number of states participating in the program. Cue expects to deliver 6m tests by the spring. 

Cue's COVID-19 Tests are being used in point-of-care settings to provide molecular confirmation to antigen tests that yield positive and suspicious negative results, eliminating the need to send results to a central lab and thereby enabling healthcare providers to respond immediately.

The Cue COVID-19 Test is being used in a range of applications by the departments of public health in each state.

The tests are being distributed for use in high-concern populations and congregate care settings, such as long-term care facilities, nursing homes, and hospices, as well as in public health and safety screenings such as mobile testing units, drive-through clinics, K-12 schools, and hospitals.

Tests are also being sent to tribal nations and rural communities where access to laboratories is minimal and results are not received for several days.

In some states, tests are being provided to essential businesses, fire and police departments, and front-line workers.

Correctional facilities and juvenile detention centers are also using Cue tests to monitor and prevent outbreaks.

Cue's easy-to-use, fast, molecular test provides lab-quality results directly to connected mobile phones.

While each state has autonomy over how to best deploy the Cue test, notable use cases include the following: in Pennsylvania, the Children's Hospital of Philadelphia is using the tests for teachers and staff in K-12 schools in five counties.

In Minnesota, Cue's tests are being deployed to assist underserved homeless populations and correctional facilities.

In Utah, the test is being used in schools, long-term care facilities, drive-through clinics, and community testing centers to identify hot-spots and prevent community spread after the holidays.

In November 2020, Cue announced its COVID-19 Tests had been deployed to five states as part of the program's launch: Alaska, Florida, Louisiana, New Jersey, and Texas.

The tests have been utilized in various ways, including at Veteran Affairs Medical Centers in New Jersey, fish processing plants in hard-to-reach regions of Alaska, and nursing homes in Louisiana.

Cue's COVID-19 Test is a portable, compact molecular test that detects the RNA of SARS-CoV-2 using a nasal swab (the Cue Sample Wand) taken from the lower part of the nose.

Specimen collection and execution of the test is simple, requires no training, and is completely automated in its process of sample to result.

Cue's molecular assay and connected platform, which provide results to a mobile smart device in about 20 minutes, is an efficient solution for frequent, fast, and reliable testing at point-of-care.

The Cue COVID-19 Test received Emergency Use Authorization from the US Food and Drug Administration on June 10, 2020. The test is authorized for use in point-of-care settings operating under a CLIA certificate of Waiver, certificate of Compliance, or certificate of Accreditation.

On October 13, 2020, HHS and DOD announced an award to Cue that will enable the company to expand its industrial base and US production capacity to deliver six m COVID-19 Tests and 30,000 Monitoring Systems to the US government, to support the domestic pandemic response.

This effort is being led by the DOD's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in coordination with the DOD's Joint acquisition Task Force, and funded through the HHS' Office of the Assistant secretary for Health, to enable and support domestic production of critical medical resources.