Periodic Reporting for period 3 - DeteCTCs (The first multi-cancer liquid biopsy test for detection of early-stage cancer and minimal residual disease from a blood draw)
Okres sprawozdawczy: 2023-07-01 do 2024-06-30
• Summary of the context and overall objectives of the project
o What is the problem/issue being addressed?
o The University Medical Center Schleswig-Holstein (UKSH) in Germany and the medical technology company iCellate Medical AB in Sweden together inventory the opportunities for better diagnostics for breast cancer, ovarian cancer, and pancreatic cancer. Those three major cancers have devastating effects on patients and society and therefore represent an urgent need for better diagnostics and treatments. iCellate Medical’s new CellMate® bloodbased cancer test samples the cells and mutations of invasive cancers to provide the data to classify the cancer into biologically meaningful groups for better therapy decision support. The multinational company QIAGEN, provider of sample and assay technologies for molecular diagnostics, together with iCellate Medical, develops the new Artificial Intelligence (AI) algorithms to classify cancers based on the data on genomic mutations. The UKSH provides access to patient samples and clinical data to test the clinical potential and best applications in breast cancer, ovarian cancer and pancreatic cancer to in the best way benefit patients.
o Patients respond individually to cancers and to treatments. It is therefore important that each individual patient receives the treatment that is best suited to treat the patient's individual biological variant of the disease.
o In this project we sample individual invasive cancer cells that have made their way to the blood and therefore are easy to sample.
o These cells may be the most aggressive cancer cells there are, since they are on their way to seed new metastases, and may therefore be the most appropriate cancer samples to test.
o Why is it important for society?
o Cancer needs to become a manageable disease.
o To manage cancer effectively physicians and patients need access to the fundamental biological information of the patient's own specific variant of cancer, in addition to the clinical information on signs, symptoms and other findings.
o Only then can the root causes of the cancer disease be managed effectively.
o The results should be a longer life with better quality for the patient and cost savings for the healthcare system and for society.
o What are the overall objectives?
• To increase the throughput of the CellMate® laboratory test for cancer so it meets the initial clinical need.
• To optimize the AI-driven clinical decision support functionality of CellMate® to predict the origin of the cancer and suggest the optimal treatment.
• To conduct preliminary clinical testing in breast cancer, ovarian cancer, and pancreatic cancer to find the most promising initial uses of CellMate®.
• To ensure initial product uptake in healthcare organizations by way of scientific publications, after vetting for that the results are mature for dissemination and have been vetted for protecting its intellectual property rights, patents etc..
o What is the problem/issue being addressed?
o The University Medical Center Schleswig-Holstein (UKSH) in Germany and the medical technology company iCellate Medical AB in Sweden together inventory the opportunities for better diagnostics for breast cancer, ovarian cancer, and pancreatic cancer. Those three major cancers have devastating effects on patients and society and therefore represent an urgent need for better diagnostics and treatments. iCellate Medical’s new CellMate® bloodbased cancer test samples the cells and mutations of invasive cancers to provide the data to classify the cancer into biologically meaningful groups for better therapy decision support. The multinational company QIAGEN, provider of sample and assay technologies for molecular diagnostics, together with iCellate Medical, develops the new Artificial Intelligence (AI) algorithms to classify cancers based on the data on genomic mutations. The UKSH provides access to patient samples and clinical data to test the clinical potential and best applications in breast cancer, ovarian cancer and pancreatic cancer to in the best way benefit patients.
o Patients respond individually to cancers and to treatments. It is therefore important that each individual patient receives the treatment that is best suited to treat the patient's individual biological variant of the disease.
o In this project we sample individual invasive cancer cells that have made their way to the blood and therefore are easy to sample.
o These cells may be the most aggressive cancer cells there are, since they are on their way to seed new metastases, and may therefore be the most appropriate cancer samples to test.
o Why is it important for society?
o Cancer needs to become a manageable disease.
o To manage cancer effectively physicians and patients need access to the fundamental biological information of the patient's own specific variant of cancer, in addition to the clinical information on signs, symptoms and other findings.
o Only then can the root causes of the cancer disease be managed effectively.
o The results should be a longer life with better quality for the patient and cost savings for the healthcare system and for society.
o What are the overall objectives?
• To increase the throughput of the CellMate® laboratory test for cancer so it meets the initial clinical need.
• To optimize the AI-driven clinical decision support functionality of CellMate® to predict the origin of the cancer and suggest the optimal treatment.
• To conduct preliminary clinical testing in breast cancer, ovarian cancer, and pancreatic cancer to find the most promising initial uses of CellMate®.
• To ensure initial product uptake in healthcare organizations by way of scientific publications, after vetting for that the results are mature for dissemination and have been vetted for protecting its intellectual property rights, patents etc..
• Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far
• The project has continued to upgrade the CellMate® workflow with multiplexing and automation technology to sample cancer cells from blood samples on the large scale required.
• The project has come part way to optimize the analyses, based on cancer mutations, of which tissue the cancer is likely to come from, and whether the cells are cancerous or are part of some other, non-cancer, diagnosis that resembles cancer in its signs and symptoms but biologically requires a different treatment.
• The project has started to identify, by testing patient samples, the most promising initial diagnostic uses.
• The project has continued to upgrade the CellMate® workflow with multiplexing and automation technology to sample cancer cells from blood samples on the large scale required.
• The project has come part way to optimize the analyses, based on cancer mutations, of which tissue the cancer is likely to come from, and whether the cells are cancerous or are part of some other, non-cancer, diagnosis that resembles cancer in its signs and symptoms but biologically requires a different treatment.
• The project has started to identify, by testing patient samples, the most promising initial diagnostic uses.
• Progress beyond the state of the art, expected results until the end of the project and potential impacts
The project is beyond the state of the art in classifying cancers based on the presence of invasive cancer cells and of the presence of genomic cancer mutations.
The project is beyond the state of the art of the current limited bloodbased diagnostic use of cancer cells.
The current state of the art can, in late-stage already diagnosed breast, prostate and colorectal cancer patients, predict a better or a worse outcome, but cannot diagnose. Neither can it be used to aid in cancer screening, early detection, treatment prediction nor for treatment monitoring.
By the end of the project, when we have the results, we expect to be able to determine the most impactful uses for this new platform technology from both an individual patient perspective, a healthcare, and a societal perspective. We will be ready to design diagnostic performance studies (clinical trial) to collect the evidence on safety and efficacy required to bring the new test to patients.
The project is beyond the state of the art in classifying cancers based on the presence of invasive cancer cells and of the presence of genomic cancer mutations.
The project is beyond the state of the art of the current limited bloodbased diagnostic use of cancer cells.
The current state of the art can, in late-stage already diagnosed breast, prostate and colorectal cancer patients, predict a better or a worse outcome, but cannot diagnose. Neither can it be used to aid in cancer screening, early detection, treatment prediction nor for treatment monitoring.
By the end of the project, when we have the results, we expect to be able to determine the most impactful uses for this new platform technology from both an individual patient perspective, a healthcare, and a societal perspective. We will be ready to design diagnostic performance studies (clinical trial) to collect the evidence on safety and efficacy required to bring the new test to patients.