An inherent feature of oncology is personalization, i.e., conversion from the fit-to-all strategy based on applying the same chemotherapy regimens to all patients with a specific type of cancer to therapy individually tailored to the patient.

Traditional methods such as immunohistochemistry and fluorescence in situ hybridization depend on subjective assessment of tissue samples, sometimes leading to imprecise results. This can result in either under-treatment or over-treatment, highlighting the need for better diagnostics.

Recently, the concept of HER2-low expression has been proposed, indicating low expression of the HER2, undetectable by standard methods, but still being a positive predictive factor, and therefore justifying the use of targeted therapy.

Fig. 1 Current paradigm of HER2 expression scoring [1]

SDS Optic’s inPROBE® marks a pivotal shift in oncology towards personalized medicine, particularly in the assessment of protein expression like HER2. This novel in vivo approach allows the examination with optic fiber probe directly in the patient’s body without tissue extraction. The interaction between the protein and the biosensor generates an optical signal, converted into a numerical value representing the expression level, thereby providing objective and real-time results.

A clinical trial SDS-HER-01-2018 was conducted to evaluate the safety and efficacy of inPROBE®. The study involved 22 breast cancer patients, with 18 completing the trial. The aim was to correlate HER2 concentrations detected by inPROBE® with those determined based on conventional methods. Results indicated a consistent trend toward correlation of higher HER2 values with HER2-positive status defined by IHC and FISH, highlighting inPROBE®'s potential accuracy and reliability.

The trial emphasized the safety of inPROBE®, reporting no significant device-related complications. These outcomes have paved the way for further research across different cancers and other diseases where protein markers are critical.

inPROBE® not only enhances the accuracy of cancer diagnostics and treatment but also holds potential for broader scientific and industrial applications. Further studies and adaptations of this platform aim to refine the measurement and expand its use to a variety of biological materials and indications.

1. Zhang H, Peng Y. Current Biological, Pathological and Clinical Landscape of HER2-Low Breast Cancer. Cancers 2023, 15, 126.

Media contact

Karol Maryniowski Marketing, Communication and IR Manager Mail: press@sdsoptic.pl Tel: +48 668 346 186

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/55ad17a9-cdc2-42f2-b10e-df9c5e94362e

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