Cancer diagnostics firm Cynvenio Biosystems has initiated the neoadjuvant breast cancer monitoring (NEAT) trial in collaboration with TME Research for the development of new tools to detect the disease.
The multi-centre registry trial will involve monitoring 150 patients using Cynvenio’s ClearID Breast Cancer test and is set to be conducted at approximately ten stations.
By using molecular analysis, ClearID Breast Cancer is a blood test designed to detect cancer cells and provides quick, accurate real-time information on the cancer cell activity.
The test can identify circulating tumour cell burden, target and sequence genes.
It can also detect chromosome alterations that are known to cause resistance to therapy.
Collecting tumour information through a liquid biopsy enables patient data to be obtained at regular intervals using minimally invasive blood draws.
Cynvenio chief medical officer Paul Song said: “Our collaboration with TME will be the largest commercial trial where a cell-free DNA and circulating tumour cells approach is used to detect and measure residual disease.
"Building on the London academic study that focused on 14 driver mutation genes, our study will leverage next-gen sequencing using Cynvenio’s commercially available custom 27-gene breast cancer-specific panel."
The London study was conducted by Garcia-Murillas in 2015 using polymerase chain reaction (PCR).
The main objective of the trial is to leverage the registry data to develop recurrence monitoring tools and testing algorithms for patients with breast cancer.
The data is expected to aid in identifying new biomarkers to examine patient response, measure chemotherapy resistance and detect new targets for alternative chemotherapy.
In the post-operative setting, the trial will identify residual tumour burden and resistance clones or therapy-induced changes in the primary tumour.