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GLAM Report Summary

Project ID: 634928
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - GLAM (Laser Multiplexed Biosensor)

Reporting period: 2015-05-01 to 2016-10-31

Summary of the context and overall objectives of the project

Currently, differential cancer diagnosis takes place daily in clinical settings for both patient stratification and monitoring patient responses to existing treatments. However, the outcome of this diagnosis is still poor, with many deficiencies and false positives and negatives due to the low sensitivity and specificity of available methodologies. Moreover, as new targeted therapies are available to patients and to oncologists there is a need to improve personalized diagnosis and therapy (i.e. personalized medicine). Thus, personalized medicine increases the need and the urgency to have diagnosis, prognosis, and monitoring data in a ultra-sensitivity and fast enough way to allow oncologists to take the appropriate decisions before the disease and the patients get worse.
Accordingly, the main aim of the GLAM project is:
To develop a new diagnostic tool to detect biomarkers from biofluids, obtained in a non-invasive manner, specifically in urine and focusing on genitourinary cancers, enabling oncologists to take better treatment decisions. To this end, GLAM will develop an integrated device based on novel label-free photonic biosensors with ultra-sensitivity, simplicity of use, portability, multiplexing and low cost by simply applying a drop of urine and reading 10 biomarker levels.
There is a significant advancement in the technology behind the GLAM biosensor as well as its associated tasks and activities, including the next key aspects: photonics methodology, generation of new optic materials, biomarker and antibody generation, microring functionalization with antibodies, concept design of the integrated detector device, e-reader platform design, patient selection and collection of clinical samples, intellectual property rights management and patent application, dissemination of activities and first outcomes, and regulatory activities
It is remarkable that GLAM partners have already reached a preliminary proof of principle of the whole concept. Using a prototype of the biosensor the first biomarker measurements have been accomplished using the global GLAM methodology. It is also notable that IPR data has been generated and used to define a patent application based on the global technology of the GLAM project. This will warrant the future commercialization of the GLAM Biosensor and its use by oncologists worldwide in order to help them to take important decisions in personalized diagnosis and therapy monitoring of patients.
Importantly, the GLAM unique technology will make the device also usable with other biofluids aside of urine (serum, plasma, tears, saliva, synovial, peritoneal, and cerebrospinal fluid) and might also be used to help physicians in personalized medicine in many other biomarker driven diseases, aside of cancer.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

GLAM consortium already designed and generated the first prototypes of microring structures, biomarkers and antibodies in order to develop the novel photonic biosensors based on microring lasers . Moreover, antibodies have already been functionalized to the new microring structures. Additionally, contacts with oncologists have already started and this allowed to recruit the first patients for the clinical study and to collect some urine samples that will be used later for clinical validation of the biosensor.
The consortium already achieved the preliminary preclinical proof of principle with a soluble biomarker and its corresponding detecting antibody. This represents a very important step in the path to set up the tuned multiplexed platform to allow the detection of up to 10 different biomarkers without labeling, washing, or amplification steps, that will enable and guide clinical personalized treatment decisions from just a single small biological sample.
In order to integrate all the components in a small, easy-to-use, robust, fast, cheap, and single-step diagnostic device to be used in point-of-care settings, various activities have already lead to the design and generation of the first integrated chip prototype.
Finally, several aspects related to technical documentations are already implemented by all the consortium partners. They are using these new guidelines to generate additional GLAM device related information to be fully aligned and towards conformity with the essential requirement of the applicable EC Directives, which will serve as the regulatory basis for the CE Certification and ISO 13485 Certification of the finished In-Vitro Diagnostics GLAM Biosensor medical device.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

There is an urgent unmet clinical need to develop highly specific, fast, and ultra-sensitive new technologies for the analyses of different biomarkers to guide personalized therapy in GU cancer patients on time.
In this sense, the GLAM Biosensor will provide a true progress beyond the state of the art in differentiated areas like 1/ the use of photonics for diagnosis in a label-free, fast, sensitive and multiplexed measurement of cancer biomarkers with unprecedented limit of detection (< 10 pM); 2/ By the generation of particular recombinant biomarkers and better mAbs with higher affinity and specificity, the detection tools will be improved and consequently sensitivity will increase; 3/ By turning microring passive resonators into microring lasers, the sensitivity will be improved by several orders of magnitude. These active microrings plus multiplexing and packaging the chips into forefront cartridge device will position GLAM device to a novel standard of diagnosis; 4/ By providing smart, compact, innovative and integrated prototype system, the pre-clinical and clinical validations will be performed, and the basis for the future product development will be set; 5/ The most updated clinical trials, in addition to cutting-edge computer analysis tools, including self-learning software, will ensure the most advanced clinical validation of GLAM.
In global terms, GLAM will have significant impact in the early diagnosis of GU cancers. The high specificity and ultra-sensitivity will lead to a considerable reduction in the morbidity associated with prostate and other cancer biopsies; furthermore, the point-of-care format will enable efficient operations in the early diagnosis triage for these cancers. In a similar way, patients with bladder cancer are mostly treated conservatively (i.e. resection of superficial lesions and follow by cystoscopy/cytology). GLAM device will enhance the patient perception of individualized treatment; patients will be treated accordingly to their particular disease profile based on their personal biomarker profile.
Moreover, due to its broad applicability the Glam Biosensor will directly impact on several beneficiaries, starting with the users by providing technology approaches for contributing to the user health, being able to contribute to early diagnostic processes and reduce morbidity and enable better quality of life of the patients omitting more complex diagnostic approaches. There will also be social benefits by providing technology, which is inherently affordable by technology approach allowing future low cost products. Additional benefits also include: economic benefits for the health sector in terms of cost reduction which lead to an improved performance (both due to the diagnosis cost reduction and the time reduction increasing the efficiency of the health sector) are also foreseen.

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