Rehovot, Israel
Rehovot, Israel

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Ostrovsky E.,Ben - Gurion University of the Negev | Ostrovsky E.,Todos Medical Ltd. | Zelig U.,Ben - Gurion University of the Negev | Zelig U.,Todos Medical Ltd. | And 6 more authors.
IEEE Transactions on Biomedical Engineering | Year: 2013

We have developed a novel approach for detection of cancer based on biochemical analysis of peripheral blood plasma using Fourier transform infrared spectroscopy. This approach has proven to be quick, safe, minimal invasive, and effective. Our approach recognizes any signs of solid tumor presence, regardless of location in the body or cancer type by measuring a spectrum that gives information regarding the total molecular composition and structure of the peripheral blood samples. The analysis includes clinically relevant preprocessing and feature extraction with principal component analysis, and uses Fisher's linear discriminant analysis to classify between cancer patients and healthy controls. We evaluated our method with leave-one-out cross validation and were able to establish sensitivity of 93.33%, specificity of 87.8%, and overall accuracy of 90.7%. Using our method for cancer detection should result in fewer unnecessary invasive procedures and yield fast detection of solid tumors. © 1964-2012 IEEE.


Barlev E.,Rabin Medical Center | Barlev E.,Tel Aviv University | Zelig U.,Todos Medical Ltd | Bar O.,Todos Medical Ltd | And 14 more authors.
Journal of Gastroenterology | Year: 2016

Background: Early detection of colorectal cancer (CRC) can reduce mortality and morbidity. Current screening methods include colonoscopy and stool tests, but a simple low-cost blood test would increase compliance. This preliminary study assessed the utility of analyzing the entire bio-molecular profile of peripheral blood mononuclear cells (PBMCs) and plasma using Fourier transform infrared (FTIR) spectroscopy for early detection of CRC. Methods: Blood samples were prospectively collected from 62 candidates for CRC screening/diagnostic colonoscopy or surgery for colonic neoplasia. PBMCs and plasma were separated by Ficoll gradient, dried on zinc selenide slides, and placed under a FTIR microscope. FTIR spectra were analyzed for biomarkers and classified by principal component and discriminant analyses. Findings were compared among diagnostic groups. Results: Significant changes in multiple bands that can serve as CRC biomarkers were observed in PBMCs (p = ~0.01) and plasma (p = ~0.0001) spectra. There were minor but statistically significant differences in both blood components between healthy individuals and patients with benign polyps. Following multivariate analysis, the healthy individuals could be well distinguished from patients with CRC, and the patients with benign polyps were mostly distributed as a distinct subgroup within the overlap region. Leave-one-out cross-validation for evaluating method performance yielded an area under the receiver operating characteristics curve of 0.77, with sensitivity 81.5 % and specificity 71.4 %. Conclusions: Joint analysis of the biochemical profile of two blood components rather than a single biomarker is a promising strategy for early detection of CRC. Additional studies are required to validate our preliminary clinical results. © 2015, Springer Japan.


PubMed | Todos Medical Ltd, Tel Aviv University, Ben - Gurion University of the Negev, Rabin Medical Center and Soroka University Medical Center
Type: Evaluation Studies | Journal: Journal of gastroenterology | Year: 2016

Early detection of colorectal cancer (CRC) can reduce mortality and morbidity. Current screening methods include colonoscopy and stool tests, but a simple low-cost blood test would increase compliance. This preliminary study assessed the utility of analyzing the entire bio-molecular profile of peripheral blood mononuclear cells (PBMCs) and plasma using Fourier transform infrared (FTIR) spectroscopy for early detection of CRC.Blood samples were prospectively collected from 62 candidates for CRC screening/diagnostic colonoscopy or surgery for colonic neoplasia. PBMCs and plasma were separated by Ficoll gradient, dried on zinc selenide slides, and placed under a FTIR microscope. FTIR spectra were analyzed for biomarkers and classified by principal component and discriminant analyses. Findings were compared among diagnostic groups.Significant changes in multiple bands that can serve as CRC biomarkers were observed in PBMCs (p = ~0.01) and plasma (p = ~0.0001) spectra. There were minor but statistically significant differences in both blood components between healthy individuals and patients with benign polyps. Following multivariate analysis, the healthy individuals could be well distinguished from patients with CRC, and the patients with benign polyps were mostly distributed as a distinct subgroup within the overlap region. Leave-one-out cross-validation for evaluating method performance yielded an area under the receiver operating characteristics curve of 0.77, with sensitivity 81.5% and specificity 71.4%.Joint analysis of the biochemical profile of two blood components rather than a single biomarker is a promising strategy for early detection of CRC. Additional studies are required to validate our preliminary clinical results.


Zelig U.,Todos Medical Ltd | Barlev E.,Tel Aviv University | Bar O.,Todos Medical Ltd | Gross I.,Ben - Gurion University of the Negev | And 7 more authors.
BMC Cancer | Year: 2015

Background: Most of the blood tests aiming for breast cancer screening rely on quantification of a single or few biomarkers. The aim of this study was to evaluate the feasibility of detecting breast cancer by analyzing the total biochemical composition of plasma as well as peripheral blood mononuclear cells (PBMCs) using infrared spectroscopy. Methods: Blood was collected from 29 patients with confirmed breast cancer and 30 controls with benign or no breast tumors, undergoing screening for breast cancer. PBMCs and plasma were isolated and dried on a zinc selenide slide and measured under a Fourier transform infrared (FTIR) microscope to obtain their infrared absorption spectra. Differences in the spectra of PBMCs and plasma between the groups were analyzed as well as the specific influence of the relevant pathological characteristics of the cancer patients. Results: Several bands in the FTIR spectra of both blood components significantly distinguished patients with and without cancer. Employing feature extraction with quadratic discriminant analysis, a sensitivity of ~90 % and a specificity of ~80 % for breast cancer detection was achieved. These results were confirmed by Monte Carlo cross-validation. Further analysis of the cancer group revealed an influence of several clinical parameters, such as the involvement of lymph nodes, on the infrared spectra, with each blood component affected by different parameters. Conclusion: The present preliminary study suggests that FTIR spectroscopy of PBMCs and plasma is a potentially feasible and efficient tool for the early detection of breast neoplasms. An important application of our study is the distinction between benign lesions (considered as part of the non-cancer group) and malignant tumors thus reducing false positive results at screening. Furthermore, the correlation of specific spectral changes with clinical parameters of cancer patients indicates for possible contribution to diagnosis and prognosis. © 2015 Zelig et al.; licensee BioMed Central.


Zelig U.,Todos Medical Ltd | Barlev E.,Rabin Medical Center | Barlev E.,Tel Aviv University | Bar O.,Todos Medical Ltd | And 10 more authors.
BMC Cancer | Year: 2015

Background: Most of the blood tests aiming for breast cancer screening rely on quantification of a single or few biomarkers. The aim of this study was to evaluate the feasibility of detecting breast cancer by analyzing the total biochemical composition of plasma as well as peripheral blood mononuclear cells (PBMCs) using infrared spectroscopy. Methods: Blood was collected from 29 patients with confirmed breast cancer and 30 controls with benign or no breast tumors, undergoing screening for breast cancer. PBMCs and plasma were isolated and dried on a zinc selenide slide and measured under a Fourier transform infrared (FTIR) microscope to obtain their infrared absorption spectra. Differences in the spectra of PBMCs and plasma between the groups were analyzed as well as the specific influence of the relevant pathological characteristics of the cancer patients. Results: Several bands in the FTIR spectra of both blood components significantly distinguished patients with and without cancer. Employing feature extraction with quadratic discriminant analysis, a sensitivity of ~90 % and a specificity of ~80 % for breast cancer detection was achieved. These results were confirmed by Monte Carlo cross-validation. Further analysis of the cancer group revealed an influence of several clinical parameters, such as the involvement of lymph nodes, on the infrared spectra, with each blood component affected by different parameters. Conclusion: The present preliminary study suggests that FTIR spectroscopy of PBMCs and plasma is a potentially feasible and efficient tool for the early detection of breast neoplasms. An important application of our study is the distinction between benign lesions (considered as part of the non-cancer group) and malignant tumors thus reducing false positive results at screening. Furthermore, the correlation of specific spectral changes with clinical parameters of cancer patients indicates for possible contribution to diagnosis and prognosis. © 2015 Zelig et al.; licensee BioMed Central.


Grant
Agency: European Commission | Branch: H2020 | Program: SME-1 | Phase: PHC-12-2015-1 | Award Amount: 71.43K | Year: 2016

Current methods of screening for breast and colorectal cancer are limited in availability and associated with a high cost. For example, mammography equipment for breast cancer screening is particularly limited in Eastern Europe due to the expensive equipment and the required skills that a medical professional must possess. Cologaurds and colonoscopys for colorectal cancer screening are invasive and painful procedures associated with low patient compliance (50% and 37% respectively). Furthermore blood tests that have been developed to date for cancer screening have failed to demonstrate a high level of accuracy. Todos Medical have developed a simple method for cancer screening known as TBIA (Total Biochemical Infrared Analysis). The CE-marked TBIA platform is unique being the first method using blood tests to show high sensitivity (>90%) and high specificity (>80%). It is a more cost effective and less invasive solution that is more accessible to end user and motivates increased compliance by patients. It is capable of producing results rapidly with the complete process sample to result taking less than 4 hours. During phase 1, a feasibility study will be carried out, together with the planning of clinical trials in hospitals that will be performed during the innovation project, to gain the validation and bring the product to the commercialization.


Patent
Todos Medical Ltd. | Date: 2012-05-10

A method is provided including obtaining an infrared (IR) spectrum of a blood plasma sample by analyzing the blood plasma sample by infrared spectroscopy, and based on the infrared spectrum, generating an output indicative of the presence of a solid tumor or a pre-malignant condition. Other applications are also described.


Trademark
Todos Medical Ltd | Date: 2016-02-17

Cancer diagnostic apparatus and instruments. Cancer early detection and follow-up services.


Patent
Todos Medical Ltd. | Date: 2011-06-01

A method is provided comprising, obtaining an infrared (IR) spectrum of a Peripheral Blood Mononuclear Cells (PBMC) sample by analyzing the sample by infrared spectroscopy; and based on the infrared spectrum, generating an output indicative of the presence of a solid tumor or a pre-malignant condition. Other embodiments are also provided.


Patent
Todos Medical Ltd. | Date: 2013-11-14

A method is provided comprising, obtaining an infrared (IR) spectrum of a Peripheral Blood Mononuclear Cells (PBMC) sample of a subject by analyzing the sample by infrared spectroscopy; analyzing the infrared spectrum using a processor (22), and based on the analyzing using the processor, using an output device (24), generating an output indicative of the presence of a benign tumor of the subject. Other applications are also described.

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