Ongoing work as part of CERVIVA, funded by Enterprise Ireland [EI] has been developing a novel tool for cervical cancer screening based on Raman spectroscopy. Raman spectroscopy is a powerful tool that can generate a biochemical fingerprint of a sample in a rapid and non-destructive manner. Raman spectroscopy is an optical method based on inelastic light scattering. The sample is illuminated by monochromatic laser light and interactions between the incident photons and molecules in the sample result in scattering of the light. The exact energy required to excite a molecular vibration depends on the masses of the atoms involved in the vibration and the type of chemical bonds between these atoms and may be influenced by molecular structure, molecular interactions and the chemical microenvironment of the molecule. Therefore, the positions, relative intensities and shapes of the bands in a Raman spectrum carry detailed information about the molecular composition of the sample and can be thought of as a biochemical fingerprint. There is convincing evidence from our own and other laboratories that Raman spectroscopy can be used as a diagnostic tool to identify spectral changes in malignant and premalignant cells.
In our ongoing work, funded by the Enterprise Ireland Commercialisation Fund, the technology is being developed into ’the molecular Pap test’ which can potentially identify biochemical changes related to CIN and high-risk HPV infection. Raman spectroscopy can differentiate between HPV positive and HPV negative cervical ThinPrep samples with the variation between the samples being attributed to differences in protein, carbohydrate and lipid content. In other recent work, a prediction model of the biomarker protein p16INK4A expression was constructed based on fourier transformed Infrared [FTIR] spectroscopic data utilising Partial Least Squares analysis. Modelling was predominantly based on spectral features arising from nucleic acid, lipid and protein contributing features, which are influenced by the HPV interaction with the host cell.
This programme will conduct the first clinical trial of this technology for cervical screening. The trial will be based at the Coombe Women and Infants University Hospital where the pathology department currently fully accredited by INAB to ISO standards, and is in the process of applying for CLIA accreditation. This will be the first hospital based laboratory in Ireland with CLIA accreditation and will be at the forefront for clinical trials going forward. The clinical trial to be undertaken within this project will be performed under LEAN and SixSigma processes.