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A miniature Bio-photonics Companion Diagnostics platform for reliable cancer diagnosis and treatment monitoring.

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A point-of-care microdevice for accurate cancer diagnosis

Presently, most cancer-related biomarkers exhibit limited diagnostic capacity and low specificity. A European initiative has developed an innovative biosensor that can accurately measure biomarkers in body fluids at the point of care with great sensitivity.

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There is solid evidence that many cancers contain a small population of cancer-initiating or cancer stem cells responsible for tumour onset, relapse and therapy resistance. These cells also seem to have the ability to migrate to distant sites and cause metastases. However, methodologies for detecting cancer stem cells and incorporating them into routine cancer diagnosis or for monitoring response to therapy are laborious.

A portable device for detecting cancer-related biomarkers

The EU-funded BIOCDx project has developed an ultrasensitive point-of-care device for the measurement of cancer biomarkers in whole blood samples. “Our goal was to generate a robust tool for fast cancer diagnosis that will facilitate improved clinical decisions,” explains project coordinator Ioanna Zergioti. The device incorporates a microfluidics cartridge enabling the filtration of blood samples towards plasma and the selection and transfer of minute amounts of sample to the detection unit. Detection of circulating protein biomarkers is performed by a sandwich bioassay which uses nanoparticles to enhance the sensing optical signal. Utilisation of ultrasensitive photonic elements offers a 100-fold improvement in sensitivity compared to current technologies. Moreover, miniaturisation of the sensor enables development of a portable device that can be used at the point of care. The BIOCDx device is set up to detect the cancer stem cell-specific transcription factor TWIST1, which has a role in cancer metastasis. TWIST1 controls the expression of the blood circulating protein periostin and procollagen C-proteinase enhancer protein (PCOLCE), both thought to be involved in tumour development and progression. The different platforms are integrated into a portable device and have been tested using blood and plasma samples from patients with breast cancer or prostate cancer as well as healthy volunteers. An added bonus is that the BIOCDx device can be adapted to enable diagnosis of other diseases.

Reinforcing industrial technology leadership in Europe

“BIOCDx was an industry-driven effort that brought together key players from the fields of sensors, microfluidics, smart medical devices and systems, as well as biopharmaceuticals,” emphasises Zergioti. Participating SMEs have infused their know-how and experience into the key components and innovations of the BIOCDx technology. The multidisciplinary collaboration in the BIOCDx project gave rise to a new generation of smart medical devices with functionalities comparable to existing highly specialised hospital equipment. These miniaturised smart systems also offer significant improvements in terms of size, cost and affordability, reliability and robustness, low power consumption and user acceptability. BIOCDx has also contributed to strengthening Europe's position and competitiveness in the manufacturing of miniaturised smart systems. The technological knowledge gained during the project has led to the PhosPrint spin-off company for the design and development of high-quality laser bioprinting systems. In addition, LioniX International partnered with other EU companies to develop diagnostic platforms for cancer detection in urine, while a commercial point-of-care instrument is under way at the same company for the diagnosis of coronavirus. According to Zergioti: “We have demonstrated that the cooperation between universities, high-tech companies and industrial partners can lead to integrated systems with high market potential.”

Keywords

BIOCDx, cancer stem cell, point of care, cancer biomarker, TWIST1, periostin, PCOLCE

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