Abstract 1227P
Background
Assessment of HER2 status is critical for diagnosis and guiding therapy in breast cancer. However, the current immunohistochemistry-based analysis of HER2 requires tissue biopsy, is time-consuming, subjective, and semi-quantitative. This is the reason for delayed or incorrect treatment decisions and worse outcomes. To address these limitations, we developed an innovative inPROBE diagnostic device, which allows for real-time quantitative and operator-independent HER2 level determination, directly in the patient’s body.
Methods
The HER2 measurements were performed using the inPROBE device consisting of an optical sensor designed for the detection of the soluble HER2 or the anti-HER2 drug – Trastuzumab (TMAB). The in vitro inProbe testing was done on the standard HER2 protein solutions to demonstrate the device working range and the tissue accumulation of TMAB was assessed in vivo on the mouse xenograft model of a human HER2+ cancer. The device safety was confirmed on rats with a probe insertion into the mammary glands to monitor the clinical, biochemical and pathological changes.
Results
inProbe working range tested on HER2 solution was within the concentration of pg/ml – mg/ml with good linearity and selectivity toward HER2. In preclinical safety experiments, inPROBE insertion into the mammary glands did not cause any adverse clinical signs, changes in blood parameters, or histology. In alternative sets of experiments, the TMAB-inProbe proved its utility for direct detection of the anti-HER2 drug accumulating in the HER2+ tumor tissue.
Conclusions
HER2-inPROBE is a specific and sensitive sensor, allowing for rapid, quantitative analysis of HER2. Given its high adaptability, the inPROBE platform presents the potential to be used for the detection of various diseases biomarkers, without the need for tissue biopsy. The clinical trial to determine the diagnostic accuracy and safety of the inPROBE in 192 patients with early breast cancer is underway (NCT05415943).
Clinical trial identification
NCT05415943.
Editorial acknowledgement
Legal entity responsible for the study
SDS Optic.
Funding
STRATEGMED II/269364/5/NCBR/2015; EU, Horizon 2020 SME Instrument (No. 783818).
Disclosure
M. Staniszewska, M. Śmietana, M. Staniszewski: Financial interests, Institutional, Membership or affiliation: SDS Optic, Inc. All other authors have declared no conflicts of interest.
Resources from the same session
1241P - Decoding the glycan code: Pioneering early detection of non-small cell lung cancer through glycoproteomics
Presenter: Kai He
Session: Poster session 14
1242P - Implementing functional precision oncology in real-world patients: Translating extensive in vitro data into personalized treatment combining genetics and functional assays
Presenter: Dörthe Schaffrin-Nabe
Session: Poster session 14
1243P - Ocular surface squamous neoplasia early diagnosis using an AI-empowered autofluorescence multispectral imaging technique
Presenter: Abbas HABIBALAHI
Session: Poster session 14
1244P - AI-based accurate PD-L1 IHC assessment in non-small cell lung cancer across multiple sites and scanners
Presenter: Ramona Erber
Session: Poster session 14
1245P - A lymph nodal staging assessment model for various histologic types of small intestinal tumors
Presenter: YOUSHENG LI
Session: Poster session 14
1246P - Detection of alternative lengthening of telomeres (ALT) across cancer types based on tumor-normal multigene panel sequencing
Presenter: Juan Blanco Heredia
Session: Poster session 14
1247P - A detection model for EGFR mutations in lung adenocarcinoma patients based on volatile organic compounds
Presenter: Yunpeng Yang
Session: Poster session 14
1248P - Development of a high performance and noninvasive diagnostic model using blood cell-free microRNAs for multi-cancer early detection
Presenter: Jason Zhang
Session: Poster session 14
1249P - Whole genome sequencing-based cancer diagnostics in routine clinical practice: An interim analysis of two years of real-world data
Presenter: Jeffrey van Putten
Session: Poster session 14
1250P - Assessing lung carcinoma: A retrospective study on volume evaluation, consolidation and infiltration using chest OMX
Presenter: Swarnambiga Ayyachamy
Session: Poster session 14