Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - SDS-OmiProbe (Revolutionary opto-biological methodology for aggressive HER2 cancer)

Teaser

According to World Health Organization, cancer is one of the leading causes of morbidity and mortality worldwide, with approximately 14 million new cases per year. Breast cancer is the most common cancer among women and is considered the second most common cancer overall. Each...

Summary

According to World Health Organization, cancer is one of the leading causes of morbidity and mortality worldwide, with approximately 14 million new cases per year.
Breast cancer is the most common cancer among women and is considered the second most common cancer overall. Each year about 1.7 million new cases are diagnosed worldwide and over 500,000 women die from the disease.
Current diagnosis methods of cancers fail to deliver objective results. Diagnosis require extracting tissue samples via invasive and expensive biopsy, followed by laboratory analysis, which are subject to significant levels of discordance.

SDS Optic presents a revolutionary opto-biological methodology that allows for instant cellular processes studies including in-vivo cancer diagnosis with single-cell resolution. SDS OmiProbe detects presence and measures concentration levels of the HER2+ cancer cells in breast tumor.
It is a breakthrough device that carries the potential to address the challenges of SoA cancer markers diagnosis and biopsies. In essence, it is a laboratory test at the tip of a probe, but with greater accuracy, efficacy and quantitative results.
SDS OmiProbe may also be used as a companion diagnostic tool for targeted therapy and targeted therapy drugs.

In order to close the striking gap in the landscape of currently available cancer diagnostic and targeted therapy tools, and to realize the significant global business opportunity the objective of this project is optimization of the SDS OmiProbe device, followed by realization of independent clinical trials and dissemination of the results.

Work performed

In scope of manufacture OmiProbe device the system has been optimized and the manufacturing concept reviewed. Special attention has been paid to OmiProbe disposable probe due to its small size and the dedicated handling method for final users.
Materials and processes have been characterized for manufacturability and availability. There have been considered also such factors like price, compactness, reliability and repeatability of processes, materials and components.
Special attention has been drawn to medical safety requirements. OmiProbe detection system and optical fibre disposable probes with relevant sensitiveness to breast cancer is ready for use in clinical trials. Disposable probes will be delivered in sequence, according to progress of clinical trials.

The following task regards to manufacturing disposable biopsy needle hermetically connected to disposable probes which allows to make the soft and painless access to breast tumors, developed to obtain the best stress ratio which is necessary to get clear signal streaming from probe to detection system.
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.

The relevant packaging process has been developed to obtain safe transportation the whole system (i.e. probe inside the needle, detection system) to the trial sites.
The relevant sterilization process for probe has been developed to obtain necessary sterility for medical devices.

Final results

SDS-OmiProbe is presently designed especially for diagnostics of HER2-positive breast cancer. The device shortens testing of HER2 marker levels from days or weeks to only minutes.
Aside from reduced physical pain, the shortened waiting time lessens psychological burden for the patient, and the disengagement of biopsy invasion further lowers efforts of laboratory personnel. The special design of the instrument ensures rapid introduction of selected drugs, therefore promoting quicker treatment.

Key benefits of the SDS Optic SDS-OmiProbe are:
● Sensitivity – much higher than currently available (no need for tumour invasion)
● Real-Time diagnostics
● Micro-size needle – less pain for patients
● Reduced healthcare expenses and treatment cost.

The impact of cancer on society in enormous both in cost and suffering for millions of patients, their families and milieu. They are the main beneficiaries of new generation diagnostics that provide less hospital time and more family time.
Current biopsy methods cause significant psychological burden for patients due to waiting time or false positives, as well as significant work time losses.

With SDS-OmiProbe patients are exposed to less pain, stress, complications and side effects. Instant results eliminate the anxiety of not knowing and allow the therapy to begin without delay using SDS-OmiProbe for HER2 targeted therapy and monitoring.
Overall, it can help reduce the burden of therapy and allow more effective screening, taking a major step in the direction of our stated company vision to increase cancer survival by 30% by 2030.

Website & more info

More info: https://sdsoptic.pl/.