In scope of manufacture SDS-OmiProbe (branded now as inPROBE) device the system has been optimized and the manufacturing concept reviewed. Special attention has been paid to inPROBE disposable probes due to its small size and the dedicated handling method for final users. In the process of testing the sensors it was determined that four-sensor probe is needed to use for clinical trials. Algorithm development using Machine Learning necessary to correctly analyze the results obtained from the probe readings is in progress.
Materials and processes have been characterized for manufacturability and availability. The remaining cell lines producing anti-CytK and PSA antibody are being developed. Also, the recombinant antibody anti-HER2 that are suitable for inPROBE functionalization involving the orientation-specific approach has been obtained from the commercial source, and antibody has been confirmed to be suitable for further functionalization procedure and development of the new upgraded version of the inPROBE. Special attention has been drawn to medical safety requirements. inPROBE detection system and optical fiber disposable probes with relevant sensitiveness to breast cancer are ready for use in clinical trials. Disposable probes will be delivered in sequence, according to progress of clinical trials. The hermetic connection between needle and probe has been implemented with focus on improving the process and material management. Key design performance parameters have been verified. Special needs for tooling, facilities, material handling and skills have been identified.
To ensure complete compliance with the standards the inPROBE device, both hardware and software, has been tested and validated regarding relevant requirements with special attention to data and safety monitoring.
There was also developed and implemented a transfer of biological technology which allows SDS Optic for in-house manufacturing of biology components. Now it is possible to independently manufacture the biological components to be used in clinical trials as well as for future commercial application. The special attention has been paid to process scalability, manufacturing reproducibility and product stability.
Clinical trials have been run to prove the safety and efficacy of the probe in determining the HER2 receptor status. All necessary approvals have been obtained. Tests have been approved by the national authority, the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) granting permissions for clinical trials for medical devices and competent for clinical trials controls. Five trial sites have been designated for testing, 18 patients have taken part in Phase I of the trial and 192 patients in Phase II. First clinical site has been opened and first patients recruited in the RP3 with clinical trials ongoing in RP4. In Phase 1 finally 20 patients were enrolled with Last Patient Last Visit (LPLV) on 12th of January 2023.
100% of the system documentation necessary for the certification process was prepared. In September 2022, the QMS documentation process was completed and training on system procedures commenced. In October and November 2022, 9 internal audits were conducted to monitor the degree of implementation of the company's quality management system. In December 2022, phase 1 of the certification audit took place and in February 2023, phase 2 completing the certification process for compliance with EN ISO 13485:2016.
