Cue Health's Molecular COVID-19 Test At Par With Lab Based PCR Tests

  • Cue Health Inc HLTH announced the preprint publication of an independent clinical study demonstrating that its point of care (POC) molecular COVID-19 test is as accurate as a centralized lab-based RT-PCR
  • Cue's molecular test produces results in approximately 20 minutes.
  • The study presents findings from a head-to-head comparison of the Cue COVID-19 test against lab-based RT-PCR on paired samples from 3,037 individuals. 
  • Also Read: Despite 36% Fall, Cue Health Q2 Revenues Exceed Expectations.
  • The findings revealed a 99.4% match between results from Cue's test and the reference PCR tests, including 100% clinical sensitivity to detect positive cases, yielding no false negatives. 
  • Of this testing population, 98.7% were asymptomatic at varying infection and viral load stages. 
  • Cue's COVID-19 test has been authorized for use in the U.S. under FDA's Emergency Use Authorizations (EUA) for professional use at the point of care by healthcare providers and certified laboratories and for over-the-counter use. 
  • It is also authorized for use in Canada through Interim Order authorization from Health Canada.
  • Price Action: HLTH shares closed 0.23% lower at $4.28 on Wednesday.
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