1227P - Novel in vivo photonics-immunoassay system, inPROBE, for the rapid detection of HER2 in breast cancer

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.