Civic monitoring report

Sent on 27/02/2024 | By Fight for Health Team | @fightforhealth_

What we found out

Project objectives

The project proposed by Biogem scarl, "DETERMINATION OF A CIRCULATING MIRNA SIGNATURE WITH INNOVATIVE NANOSENSORS FOR THE DIAGNOSIS AND PROGNOSIS OF LARYNGEAL TUMORS," is important for several reasons. The issue of laryngeal tumors is not confined to a specific region but is a global concern, and early diagnosis is crucial for successful treatment. Nanosensors provide high precision in detecting specific circulating miRNAs associated with laryngeal tumors, ensuring diagnostic accuracy. Furthermore, thanks to the Smart Kit, non-invasiveness of the process is guaranteed.

Foreseen activities

The lead entity of the project is the Genetic Research Institute "G. Salvatore" Biogem scarl, born from the idea of ​​creating, in the South of Italy, a cutting-edge structure in the field of Molecular Biology. Inaugurated in 2006 in the presence of Nobel laureate Rita Levi Montalcini, Biogem operates in the field of biomedical research to facilitate the transfer of results into new and more effective diagnostic and therapeutic applications, in the field of preclinical Pharmacological Research, with the aim of developing new pharmacological approaches, and in the field of biotechnological research. The operational units involved in the project belong to this thematic area: i) the Molecular and Precision Oncology Laboratory (headed by Professor Caraglia), ii) the Protein Factory unit (headed by Dr. Nolli). The project partner is the BioTekNet Society, a Regional Center of Competence in Industrial Biotechnology, co-financed by the Campania Region under Measure 3.16 of the P.O.R. Campania 2000/2006. The Company, founded on December 14, 2007, is headquartered in Naples within the former Faculty of Medicine of the University of Campania L. Vanvitelli. It operates in the industrial biotechnology sector, conducting industrial research and technology transfer activities in the following research areas: Oncology: development of innovative models for the prediction, diagnosis, and treatment of oncological diseases; Development of innovative strategies and biotechnological processes for the production of drugs, medical devices, nutraceuticals, and cosmeceuticals; Circular economy: valorization of agri-food industry waste biomasses; Development of innovative biosensors and other biomedical devices. One of the needs of the biosensor industry in the healthcare sector for the early diagnosis of neoplasms is the identification of biomarkers on which to design the biological component to be coupled with the transduction system that converts the biochemical response into a measurable signal. To date, the design and development of biosensors based on increasingly sensitive detection technologies do not follow the research and validation of markers with high diagnostic performance measurable in terms of accuracy, sensitivity, and specificity. In this context, this project will introduce the use of new diagnostic biomarkers, detectable in biological fluids such as plasma and serum, capable of enabling early and reliable diagnosis of squamous cell carcinoma of the head and neck (HNSCC). Within the project, the characterization of the expression profile of specific markers expressed on the membrane of exosomes in patients with HNSCC will be outlined. Exosomes are nanometric-sized vesicles (30-150 nm) that are secreted by almost all types of cells, including tumor cells. The molecular constituents, such as nucleic acids, proteins, lipids, and metabolites, of exosomes vary depending on the cell type from which they originate, environmental conditions, developmental stages, epigenetic changes, and biogenesis mechanisms. The presence of exosomes has been found in numerous types of body fluids, such as plasma, serum, breast milk, urine, saliva, suggesting an active role in the regulation of physiological and pathophysiological responses, particularly in the development and progression of neoplasms. Due to the biological relevance of the bioactive molecules transported by exosomes, they have the ability to transmit intercellular signals promoting proliferation, metastasis development, and regulating drug resistance. Clinically, exosomes function as diagnostic biomarkers, therapeutic targets, or even as vehicles for the administration of antitumor drugs. The proteins contained in these vesicles, as well as those expressed on the surface membranes, reflect the protein expression pattern of the parent cells. The characterization of the expression profile of membrane exosomal proteins will allow the definition of new circulating biomarkers of HNSCC. In parallel, a diagnostic kit based on the detection of such surface markers identified on exosomal vesicles will be developed as an indicator of the risk of developing HNSCC. The diagnostic kit to be developed will be based on an innovative technology already developed within the SENSORMIRCIRCOLAR project financed by the Campania Region under the previous Public Notice for support to Campanian companies in the implementation of feasibility studies (Phase 1) and technology transfer projects (Phase 2) consistent with RIS3 (Regional Innovation Strategy for Smart Specialization) (Regional Law No. 65/2017), for the detection of circulating microRNAs of diagnostic interest. The biosensor to be developed will use aptamers specifically designed for the recognition of exosomal biomarkers, allowing early and more reliable diagnosis of squamous cell carcinoma of the head and neck (HNSCC) and represent the most innovative technology towards which the market is currently trending, destined to replace previous systems based on circulating tumor DNA. This aptamer-exosome interaction transducer device consists of electrospun nanofibers of a polymer blend, suitably decorated with metallic nanoparticles of different shapes and sizes serving as an optical platform (SERS, LSPR) capable of amplifying the biomolecular signal, functioning as biosensors for detection, through various methodologies (colorimetric, fluorescence, spectrometry etc), of one or more biomarkers of interest. The developed device will have relatively low costs compared to current ones and will be easy to use in clinical practice. The production objectives of the project consist in providing the biosensor industry with new biological substrates of interest for the development of biosensors based on the simultaneous detection of a molecular signature for the diagnosis of HNSCCs. Internationally, the biomarker market size was $39.10 billion and is expected to reach $97.51 billion by 2026, with a compound annual growth rate of 12.1% during the forecast period. Biomarkers play a key role in personalized medicine, and their use in diagnostic settings in the future will be considered essential for neoplasms with particularly unfavorable prognosis due to late diagnosis resulting from the absence of specific symptoms. This is the case of HNSCCs for which, to date, the number of validated biomarkers is still small, compared to the landscape of molecules of diagnostic interest currently used for other neoplasms with comparable incidence and survival rates to HNSCCs. In the future, there is expected to be increasing interest from the pharmaceutical and biosensor industry in HNSCC biomarkers and market growth for this category of biomolecules. In this productive context, the present project has two strategic objectives: quantification of the expression and validation of the diagnostic and prognostic relevance of new tumor biomarkers, specifically proteins expressed on the membrane of exosomes, in liquid biopsy samples from patients with HNSCC; patenting and industrialization of a new SERS biosensor for the detection of tumor exosomes indicative of HNSCC, more reliable than the biomarkers currently used for the diagnosis of such pathologies. The objective is to promote and improve existing diagnostic technologies by providing useful tools for the early detection of HNSCC, providing the biosensor industry with: new molecular targets to be used as a biological component for the multiple detection of diagnostic biomarkers of HNSCC in liquid biopsy samples; an innovative biosensor based on the detection of exosomes for the early diagnosis of HNSCC.
The technology used for the biosensor will allow the design of a device that is easy to use in clinical practice, at relatively low costs.
The project started on 30/10/2018, and the originally planned end date was set for 30/04/2020. The monitored public cost amounting to €974,328.00 has not been fully spent, yet the project is reported as completed.

Project origin

The project originates from the DECREE No. 641 OF 30/10/2018 – CUP B93D18000330007 Project co-financed by the European Union, the Italian State, and the Campania Region, within the framework of the Campania ERDF 2014-2020 Operational Program – OS 1.1 and 1.4 Notice for supporting Campanian businesses in the implementation of feasibility studies (Phase 1) and technology transfer projects (Phase 2) consistent with the RIS3.
The entities involved are: the University of Vanvitelli, USP UNION OF PHARMACEUTICAL SCIENCES SRL, Biogem, BioTekNet Society


The subjects who can benefit from the outcomes of the project are hospitals and individuals at high risk.
Hospitals will benefit from the implementation of a less invasive diagnostic tool for laryngeal tumors. Currently, diagnostic procedures can be invasive and require longer times to obtain precise results. With this new technology, hospitals will be able to conduct more timely and accurate diagnoses, allowing for more effective and timely treatment for patients with laryngeal cancer.
Individuals at high risk: People at a high risk of developing laryngeal cancer will gain significant advantages from this project. The less invasive diagnostic tool will make regular monitoring more manageable and accessible for those who are more susceptible to this condition. This may include individuals with a family history of laryngeal tumors or those exposed to specific environmental or professional risk factors.


The justification for project funding lies in the fact that worldwide, pharyngeal and laryngeal cancers represent approximately 4% of all malignant neoplasms diagnosed in men and 1% in women.
In Italy, there are approximately 2,800 new cases of laryngeal cancer among men and 500 among women each year. Pharyngeal cancers have a similar incidence in women and slightly lower in men but with higher mortality compared to laryngeal cancers. In Italy, around 2,250 new cases are reported annually in men and 650 in women. The trend is on the rise.


Monitoring the project reveals its successful conclusion through the identification of circulating MiRNAs, achieved by the development of a cutting-edge nanosensor.The nanosensor has been tested and the expected results have been achieved, as it distinguishes healthy cells from tumor cells. The first experiments will start shortly, but the research is ongoing to expand the investigation to new biomarkers, as the prototype can also be adapted to other types of biomarkers. (Source: Interview)


The project reached its successful culmination by identifying MiRNAs and creating an innovative nanosensor, with the project officially filed and testing poised to commence imminently. Furthermore, an exciting new prototype is underway, demanding approximately 1000 cases for rigorous validation of its groundbreaking potential. (Source:interview)


The research demands a significant commitment, with highly trained physicians dedicated to a task of great complexity. However, the in-depth and intricate nature of the study can lead to delays compared to the initial plan and deviations from the original timeline. These inevitable challenges can pose hurdles in project management. Nevertheless, given the nobility of the cause and the enthusiasm of the researchers, these obstacles are surmountable, as the research tirelessly pursues a goal of fundamental importance for health and well-being.


We are facing a project that has boldly embraced innovation, adopting cutting-edge methodologies, advanced technologies, and original approaches in solving research challenges. The culmination of this effort has resulted in an extraordinary success: the creation of a functional nanosensor capable of detecting the presence of tumor cells. This achievement marks a groundbreaking step in the research for early diagnosis of one of the leading causes of mortality, promising a brighter future in the fight against this disease.The collaboration of numerous researchers on this project stands out as a notable strength, manifesting in the augmented recruitment of highly skilled professionals adept at navigating the intricate challenges inherent in research.


The future risks of this project may be linked to challenges in collecting samples for testing or potential disruptions in collaboration with Hospital (Cardarelli Hospital, Rummo Hospital in Benevento).
However, a crucial factor that could jeopardize the continuity of experiments is the possible lack of funds. Ongoing financial support is essential for the research to progress through experimental phases, and the absence of funding could significantly compromise the pursuit of scientific objectives and the subsequent validation of results.

Ideas and solutions

*Ensure adequate funding to support research, experimentation, and monitoring activities throughout the project (to expand research to new biomarkers).
*Expand collaborations for the collection of biopsy samples.
*Launch awareness and information campaigns to educate the public about the significance of the research, actively involving them in its promotion and dissemination.

Investigation method

How was the information collected?

  • Web research
  • Visit to the project's location, documented by pictures or videos
  • Interview with the Managing Authority of the Programme which financed the project
  • Interview with people responsible for the project's implementation

Dr Tullio Bongo Administrative Director at Biogem
Dr Michele Caraglia Director of the Laboratory of Molecular and Precision Oncology at Biogem
Dr Marianna Scrima Manager of the Laboratory of Molecular and Precision Oncology at Biogem

Main questions

1. What are the main progress made in the development of the diagnostic kit, and what have been the results of the tests conducted so far (Dr. Michele Caraglia The Director of the Laboratory of Molecular and Precision Oncology at Biogem)
2. What are the next planned steps for the project, and how do you intend to ensure its practical application and dissemination (Dr. Michele Caraglia The Director of the Laboratory of Molecular and Precision Oncology at Biogem)

Main answers

1. We have designed a nanosensor that is based on nanotechnology and is capable of diagnosing directly from a droplet of blood. When a drop of blood is placed on this strip, similar to a COVID test, a reaction occurs. We can then determine if the exosome, a specific shuttle for laryngeal cancer, is present, allowing for a simple and easy tumor diagnosis. This is crucial because laryngeal cancer is challenging to diagnose using traditional methods like laryngoscopy, which involves inserting a tube into the throat to visualize the tumor and collect a sample. With our smart kit, diagnosis becomes much simpler. Currently, we are in the process of developing this nanosensor, and next week, we will have the first prototype of this sensor. We need to file a patent and reach out to industries so that they can contribute to the development of this device.
2. we are now to developping the best strategy to visulize this shuttle this exosome on this stripe, paper stripe and then ones we have developped the first prototipe we have to performe an industrial development of this prototipe and we have to deposit the patent that is the next step ones deposed the patent we have to develope the nonosensor with the texting of the nanosensor of very large population we need about 1.000 people in order to determine the efficacys the sensitivity and the specificity of the kit, then we have to ask the approuval from the regulation agensis italian agencies and european agencies thanwhen we receive the approuval we can commercialize the kit