SAN DIEGO, Jan. 19, 2021 /PRNewswire/ — Cue Health Inc. (Cue) announced today that its molecular, point-of-care COVID-19 Assessments are being dispersed to five extra states, such as Colorado, Minnesota, Pennsylvania, Rhode Island and Utah, as portion of the joint $481 million plan with the U.S. Division of Wellness and Human Providers (HHS) and the Division of Protection (DOD). This expansion doubles the range of states collaborating in the method. Cue expects to produce 6 million exams by the spring. Cue’s COVID-19 Checks are currently being utilized in point-of-care settings to provide molecular affirmation to antigen checks that yield favourable and suspicious unfavorable success, reducing the want to mail final results to a central lab and therefore enabling healthcare companies to reply immediately.
The Cue COVID-19 Exam is getting utilized in a assortment of purposes by the departments of general public health in every single point out. The tests are staying distributed for use in substantial-concern populations and congregate treatment options, this sort of as extensive-term treatment amenities, nursing homes, and hospices, as nicely as in public well being and protection screenings this kind of as cellular tests units, generate-through clinics, K-12 universities, and hospitals. Checks are also staying sent to tribal nations and rural communities where by entry to laboratories is small and outcomes are not been given for various days. In some states, exams are currently being offered to necessary corporations, fire and police departments, and entrance-line personnel. Correctional facilities and juvenile detention centers are also utilizing Cue exams to check and avoid outbreaks.
“Cue is happy to increase this vital system, scale our production, and deploy our take a look at to make a good impact on the overall health of communities alongside HHS and DOD,” claimed Ayub Khattak, CEO of Cue.
Cue’s uncomplicated-to-use, fast, molecular test provides lab-high-quality effects immediately to connected mobile telephones. “Cue’s COVID-19 Test is an economical answer at the issue-of-care, and is a essential section of our method to provide the appropriate exam, for the suitable human being, at the correct time,” said Assistant Secretary for Health and COVID-19 Screening Coordinator, Admiral Brett P. Giroir, M.D. “Although this method is in the pilot phase, we have by now seen a significant effects in communities throughout the state. It is our aim to deploy hundreds of thousands far more of these checks that enable make improvements to infection management.”
Though each and every condition has autonomy in excess of how to most effective deploy the Cue check, noteworthy use conditions involve the subsequent: in Pennsylvania, the Kid’s Clinic of Philadelphia is applying the tests for instructors and personnel in K-12 schools in 5 counties. In Minnesota, Cue’s exams are staying deployed to support underserved homeless populations and correctional services. In Utah, the take a look at is staying made use of in colleges, very long-expression care amenities, travel-by clinics, and local community testing facilities to recognize hot-places and stop neighborhood spread after the holidays.
In November 2020, Cue declared its COVID-19 Exams experienced been deployed to 5 states as aspect of the program’s start: Alaska, Florida, Louisiana, New Jersey, and Texas. The tests have been used in several methods, including at Veteran Affairs Healthcare Centers in New Jersey, fish processing plants in really hard-to-get to locations of Alaska, and nursing residences in Louisiana.
Cue’s COVID-19 Examination is a transportable, compact, quick-to-use, molecular test that detects the RNA of SARS-CoV-2 employing a nasal swab (the Cue Sample Wand) taken from the decreased component of the nose. Specimen assortment and execution of the test is uncomplicated, necessitates no teaching, and is entirely automated in its method of sample to end result. Cue’s molecular assay and linked platform, which supply benefits to a cell good machine in about 20 minutes, is an productive remedy for recurrent, speedy, and reliable testing at issue-of-treatment.
The Cue COVID-19 Take a look at acquired Crisis Use Authorization (EUA) from the U.S. Food stuff and Drug Administration (Fda) on June 10, 2020. The exam is authorized for use in position-of-care configurations operating below a CLIA Certification of Waiver, Certificate of Compliance, or Certification of Accreditation.
On October 13, 2020, HHS and DOD announced an award to Cue that will empower the enterprise to extend its industrial base and U.S. creation capability to produce six million COVID-19 Exams and 30,000 Checking Units to the U.S. federal government, to assist the domestic pandemic response. This energy is staying led by the DOD’s Joint Software Executive Place of work for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in coordination with the DOD’s Joint Acquisition Job Drive (JATF), and funded by means of the HHS’ Business office of the Assistant Secretary for Wellbeing, to empower and aid domestic production of vital medical assets.
About Cue Health and fitness
Cue Wellbeing Inc. (“Cue”) is an ISO 13485-accredited company focused on acquiring and producing professional and buyer healthcare diagnostic products that can be applied in scientific or at-house settings. Cue’s mission is to make tools that empower health care vendors and shoppers by escalating their entry to actionable wellbeing facts. Cue’s initial product or service, the Cue Well being Monitoring System with the Cue COVID-19 Test Cartridge, is a system that gives diagnostic info to clinicians and patients trying to get to gain from a linked health care supply ecosystem. The enterprise is based mostly in San Diego, CA. For additional information and facts visit www.cuehealth.com
This examination has not been Food and drug administration cleared or permitted this test has been licensed by Fda below an EUA for use by licensed laboratories this check has been licensed only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens and this exam is only licensed for the length of the declaration that circumstances exist justifying the authorization of crisis use of in vitro diagnostics for detection and/or prognosis of COVID-19 beneath Portion 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless of course the authorization is terminated or revoked sooner.
Supply Cue Wellbeing Inc.