Development and Validation of saliva diagnostics

• Research type

  Research Study

• Full title

  Development of diagnostic devices using saliva as a matrix and determination of their validity and utility for a range of markers and conditions.

• IRAS ID

  300354

• Contact name

  David Klug

• Contact email

  david@vidyahealth.com

• Sponsor organisation

  Vidya Holdingd Ltd

• Duration of Study in the UK

  5 years, 0 months, 0 days

• Research summary

  Saliva contains most of the same small molecules, proteins and nucleic acid markers that can be found in blood. The central challenge to using saliva as a diagnostic matrix is that these markers are generally present at much lower concentrations. Vidya has developed ultrasensitive measurement technology, with single-molecule sensitivity which enables very low levels of molecular marker to be quantified with high accuracy. The core of the technology is a sandwich assay format, miniaturised within a microfluidic device and analysed with single molecule sensitivity.
  [1, 2, 3, 4, 5, 6]
  This is a study designed to demonstrate 1. that Vidya can develop a wide range of assays for its technology platform using off the shelf reagents. 2. That Vidya technology applied to salivary samples, can produce sufficient reliability and analytical reproducibility/precision to be used as an alternative to blood-based assays for particular markers.
  

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  21/NE/0129

• Date of REC Opinion

  13 Aug 2021

• REC opinion

  Further Information Favourable Opinion