Periodic Reporting for period 1 - DIADEPH (Preventing unnecessary biopsies in the diagnosis pathway of cervical cancer.)
Reporting period: 2021-07-01 to 2022-12-31
The DIADEPH Proof-of-Concept's goal was to improve the current diagnostic pathway of cervical cancer through a new tool that could replace colposcopies, avoiding invasive and sometimes unnecessary biopsies. This project stems from a working tool for skin applications created during the ERC DIDYMUS consolidation project.
More than half a million women are diagnosed with cervical cancer each year: for half, the diagnosis is a death sentence. This terrible disease often affects young lives: in Europe, it is the second most common form of cancer among women aged 15-44. The diagnostic evaluation begins if, during a periodic screening, the patient tests positive for high-risk Human Papilloma Virus. The patient is then referred primarily for colposcopy to look for possible signs of cervical intraepithelial neoplasia (CIN). Unfortunately, this test leaves much to be desired: even for high-grade lesions (CIN3) colposcopy gives a false negative in almost one out of three cases.
To address the shortcomings of colposcopy, the team prototyped a novel transvaginal probe that obtains two independent malignancy indicators: (1) a high-resolution 3D image of the subsurface and (2) a quantitative assessment of its mechanical properties. With this tool, data could be collected during a procedure that doesn't generate discomfort and should provide a better diagnosis in minutes.
The new prototype for the gynecological application has been successfully developed.
In terms of exploitation, the interaction with the stakeholders highlighted that the current gold standard is hard to replace, and that the business case for the proposed system is not appealing to investors. In fact, the investment needed to obtain the CE certification would hardly pay back given the expected limited adoption rate by gynecologists.
The team has further evaluated another possible exploitation strategy for the project results, namely, applications in dermatology (skin cancer screening and cosmetic assessments). Unfortunately, also in this field, the added value of the combined approaches (suction and OCT) seems not to be sufficiently strong to induce a market shift.
More than half a million women are diagnosed with cervical cancer each year: for half, the diagnosis is a death sentence. This terrible disease often affects young lives: in Europe, it is the second most common form of cancer among women aged 15-44. The diagnostic evaluation begins if, during a periodic screening, the patient tests positive for high-risk Human Papilloma Virus. The patient is then referred primarily for colposcopy to look for possible signs of cervical intraepithelial neoplasia (CIN). Unfortunately, this test leaves much to be desired: even for high-grade lesions (CIN3) colposcopy gives a false negative in almost one out of three cases.
To address the shortcomings of colposcopy, the team prototyped a novel transvaginal probe that obtains two independent malignancy indicators: (1) a high-resolution 3D image of the subsurface and (2) a quantitative assessment of its mechanical properties. With this tool, data could be collected during a procedure that doesn't generate discomfort and should provide a better diagnosis in minutes.
The new prototype for the gynecological application has been successfully developed.
In terms of exploitation, the interaction with the stakeholders highlighted that the current gold standard is hard to replace, and that the business case for the proposed system is not appealing to investors. In fact, the investment needed to obtain the CE certification would hardly pay back given the expected limited adoption rate by gynecologists.
The team has further evaluated another possible exploitation strategy for the project results, namely, applications in dermatology (skin cancer screening and cosmetic assessments). Unfortunately, also in this field, the added value of the combined approaches (suction and OCT) seems not to be sufficiently strong to induce a market shift.