NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

Cue Health Inc

Business Name:
Cue Health Inc
Business Genre:
Business Description:

Cue Health Inc. is an venture funded company that is trying to develop a portable diagnostic and smart phone app for at-home and point of care use.

City:
San Diego
State:
CA
Data/Evidence of Effectiveness:
“• Inclusivity: in silico analysis • Cross-reactivity: in silico analysis and wet lab testing for 31 potentially cross-reacting organisms • Interfering substances: tests many common substances at highest possible concentrations • Clinical Validation: Prospective Study: 6 positive and 35 negative. 100% agreement for positive cases and 92% agreement for negative cases. • Clinical Validation: Retrospective Study: 100% agreement with 45 postive patients • Clinical Validation: Contrived positive: 30 negative samples (100% agreement) and 19/20 positive detection (95% agreement) [1] “
Complimentary Products Needed to Perform Test:
“• The Cue Health Monitoring System (Cue Cartridge Reader) • The Cue Health App on the Apple® iPhone® 8+ or newer mobile smart device with iOS 13 (or higher).”” • “Cue COVID-19 External Control Swabs Pack (REF 2110) that contains three Cue COVID-19 Test Positive Control Swabs (REF C2111) and three Cue Test Negative Control Swabs (REF C2112) from Cue Health Inc.”” [1] “
Setting of Care:
Currently CLIA labs and POC facilities. ” 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. ” [3]
Current Status / Clinical Development Stage / Expected Milestones:
They are EUA approved for CLIA labs and POC facilities. They plan to get addition permission from the FDA to allow more locations.
LOD:
1.3 copies /uL or 1,300 copies/mL [1]
Funding & Ownership :
They are funded by venture. They made $100M in Series C funding and won a $13M grant from BARDA. They have made investors, such as Decheng Capital, Foresite Capital, Madrone Capital Partners, ACME Capital, Johnson & Johnson Innovation, and more.[2]
Business Model:
They are funded by venture. [2]
IP:
They have several relavant patents [5]
Date EUA Issued:
6/10/2020 [1]
Sources:
[1] https://www.fda.gov/media/138826/download [2] https://www.crunchbase.com/organization/cue-2 [3] https://www.cuehealth.com/news-listing/2020/6/11/1vhtsyzexgjv5kfa314fvisiy2elw5 [4] https://www.cuehealth.com/about [5]https://patents.google.com/patent/US10589267B2/en?q=cue+health&oq=cue+health
Organization:
Their CEO and founder is Ayub Khattak. A cofounder is also Clint Sever who serves as CPO. [4]
No. Tests Per Day:
30 minutes per test. 24 hours per day x 2 test per hour= 48 tests
Time to Result:
25 minutes [1]
Test Sample Type:
“nasal swab sample taken from the lower part of the nose” [3]
Technology Overview:
“””The Cue COVID-19 Test is an isothermal nucleic acid amplification assay intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in direct nasal swabs from individuals who are suspected of COVID-19 by their healthcare provider. The test is run using the Cue Health Monitoring System (Cue Cartridge Reader), the Cue COVID-19 Test Cartridge, the Cue Sample Wand, and the Cue Health App on the Apple® iPhone® 8+ or newer mobile smart device with iOS 13 (or higher).”” [1]”
Testing Type:
qualitative viral RNA test [1]
Test Category:
RT-PCR
Test Name:
Cue COVID-19 Test
Clinical Application & Need:
acute infection [1]

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