In the medical diagnostics industry, there is an ever-increasing need for the development of robust, reliable, accurate and fast devices for early diagnosis, screening and monitoring of diseases allowing for the presently emerging paradigm shift of Personalized Medicine and Companion Diagnostics. There is a special interest in cancer.
BIOCDx aims to develop a miniaturized, ultra-sensitive and reliable Point-of-Care (PoC) device with disposable microfluidic cartridge for the monitoring of cancer biomarkers in body fluids and specifically in whole blood samples. The proposed PoC device will aid primary tumour and metastases detection, as well as monitoring of drug efficacy as a companion diagnostic. It will provide clinicians, caretakers and patients with a more sensitive, robust and selective tool for improved clinical decisions through the early and fast diagnosis of the disease, as well as monitoring of therapeutic response, reducing the cost of the healthcare system. Besides the obvious health benefit for the patient, it will contribute to the sustainability of the European health care system by decreasing the expenditure associated with pharmaceutical treatments and with hospitalization.
One of the scientific breakthroughs of BIOCDx is the development of a “cancer stem cells” detection platform by virtue of expression of the cancer stem cell-specific transcription factor TWIST1, which controls the expression of the bloodstream circulating biomarkers like the periostin (POSTN) protein. Cancer stem cells represent the most aggressive/tumorigenic cell compartment within tumours and are known to support primary tumour growth and to migrate to distant tissues and establish secondary tumours (metastases). They are also believed to survive chemotherapy and upon completion of treatment, they grow back leading to tumour recurrence. These recurrences evolve to ever more resistant tumours with fatal outcome.
To do so, BIOCDx will combine advanced concepts from the photonic, nano-biochemical and fluidic parts and reader/packaging platforms aiming to overcome limitations related to detection reliability, sensitivity, specificity, compactness and cost issues. BIOCDx will use ultrasensitive, photonic elements based on an array of 8 asymmetric MZI waveguides fabricated by TriPlex technology on silicon nitride substrates and aiming to achieve a 100 fold improvement of the sensitivity (<10-8 RIU) with respect to current technologies. A sandwich assay, enhanced with nanoparticles, will be developed, based on the use of two antibodies per protein, to detect all three circulating proteins. This will enhance the limit of detection (LOD) close to femtomolar. BIOCDx photonic, nano-biochemical, fluidics and packaging platforms will be integrated into a POC device which will be validated in preclinical and clinical settings for three cancer types: breast cancer, hormone-independent prostate cancer and melanoma.
