The patented device SCENT A1, both in Italy and in Europe, is designed for preventive screening of colorectal cancer (CRC). Currently, CRC prevention relies on fecal occult blood test (FOBT), which shows a high number of false positives, followed by colonoscopy, invasive and expensive. Once entered into the market, the instrument will provide the healthcare system, a safe and effective preventive diagnosis method, supporting FOBT, already accepted by the healthcare system and mandatory for all subjects between the ages of 50 and 69. SCENT A1 will work alongside FOBT, with the aim of reducing false positives of the latter, i.e., healthy people who will have to undergo colonoscopy without any real need. It aims therefore to optimize the number of operative colonoscopies, eliminating the unnecessary ones. After clinical validation, SCENT A1 will be proposed as a pre-diagnosis method for the population risk, in those countries in which FOBT or any type of preventive screening are not employed, such as in Russia, Poland, Brazil, Argentina, Spain. The introduction of SCENT A1 will also reduce the number of deaths due to tumors not diagnosed by FOBT, with a significant social and health impact.
SCENT A1 consists of a core of semiconductor gas sensors, capable of varying their resistance as a function of the gas reacting with their surface. The device allows in-vitro (therefore non-invasive) analysis of stool samples exhalations. The composition of faeces is in fact altered by the presence of volatile biomarkers produced by peroxidation of tumor cells and by metabolic alterations in the presence of tumors. Such compounds make the stool odor of subjects affected by CCR different from the odor of healthy subjects’ faeces. Samples should be stored in a freezer in a standard container before analysis. The processed data provide a response to the patient’s state of health.
Since May 2016, after a preliminary feasibility study, SCENT A1 is being clinically validated by the doctors of St. Anna Hospital, AUSL and University of Ferrara and, from September 2017, also of the Lagosanto Delta Hospital. People resulted positive to FOBT may take part in the study by taking an extra stool sample to be analyzed prior to performing colonoscopy (gold standard). The collected data will serve to validate the instrument. The term of the protocol is scheduled for 2019.
The SCENT B1 device is conceived of two types of application. The first one concerns the postoperative monitoring of blood samples for detecting the presence of volatile tumor markers produced by local tumor masses or metastases. The second one, related to basic scientific research, concerns the classification of cell cultures basing on type, age, health status (e.g., healthy or tumor cells). The aim is to obtain useful information on cells as the fundamental tumor development units. SCENT B1 is composed of a basic structure similar to SCENT A1 and the core are always gas sensors. Moreover, the application of specific materials for the intended purpose (and their synthesis methods) is object of a national patent. As far as blood application is concerned, a number of laboratory tests have been carried out on samples of healthy control subjects and on subjects with different types of vascularized cancer. Data processing has led to very encouraging results: the distinction between the two populations is clear, especially where metastases are present. Regarding instead cellular application, studies on primary and immortalized cell cultures have been carried out to date, showing the capability of these sensing materials of differentiating populations with a wide margin of trust.