This study indicates the potential use of OrSense's NBM device as a noninvasive sensor for continuous blood glucose evaluation. The device was safe and well tolerated.
Background: NSCLC induces pro-tumorigenic immunosuppressive changes to evade the immune system. Response of tumors to therapy, including to immunotherapy, depends on interactions of epithelial tumor cells and the microenvironment. Ex vivo culture (EVOC) models directly established from fresh NSCLC tumor tissues can be used as a complete model that resembles real tumor and its microenvironment. Little is known about the impact of drugs such as chemotherapy, radiotherapy or targeted agents on the expression and activity of the PD1-PDL1 signaling in human cancers. Combining such treatments with immunotherapy seems to be a promising approach that is actively investigated. We are using an EVOC model to study the impact of anti-PDL1 agents in NSCLC, alone or in combination with other therapeutics (chemotherapy or radiotherapy). Results: Our results indicate our EVOC model applicability as modeling immunotherapy effects in cancer. Specifically, tumor and stromal cells are maintained with a stable structure over a time window of several days and cell death is seen in response to cytotoxic drugs. Importantly, PDL1 is dramatically induced in response to inflammation signals (e.g. IFNg), PDL1 is reduced in response to steroids and variability in PDL-1 expression is seen between EVOCs from different NSCLC patients. Conclusions: NSCLC EVOC is a promising model for elucidation of immunotherapy and other drugs impact on real human cancer with its native microenvironment and immune cells.
Background: The performance of the NBM-100, a new non-invasive Hematocrit (Hct) measurement device, was tested in primary and secondary medical care environments. The device utilizes a finger sensor with Occlusion Red/Near-Infrared Spectroscopy (O-RNIRS) technology to non-invasively measure hemoglobin and Hct levels (Figure). A non-invasive Hct measurement has many potential advantages including the prevention of pain and potential transmission of infectious diseases, and the reduced need for trained technicians. Methods: In order to investigate the use of the device in both primary and secondary medical environments, clinical trials were conducted in a blood donation center (USA), an oncology clinic (USA) and a hematology clinic (Israel). The studies were carried out on a group of 304 subjects (155 Female, 149 Male), ages 18–96 (average age 54.9). After signing a written consent, all study volunteers were tested non-invasively with the NBM-100 device, and invasively, using a venous sample evaluated on a Cell-Dyn (Abbott) blood analyzer. At the blood donation center the NBM-100 measurements were performed before donation, and the venous blood sample was taken after donation. To neutralize the decrease in Hct occurring during blood donation, as described in published clinical trials, a value of 2.2% was added to the reference venous values obtained from the blood donation center. Results: The operating staff at all centers found the NBM-100 easy to use and appreciated by subjects. The venous Hct measurements ranged from 15% to 51%. The mean NBM-100 Hct was 36%, the same as the mean venous result. The mean absolute error (MAE) was 2.66% and the relative absolute error (RAE) was 7.9%. The standard deviation of the difference between the venous reference and noninvasive Hct readings was found to be 3.34% and the correlation between the two devices was r=0.9. The bias between the two methods was a negligible 0.40%. Conclusions: This study supports the use of the NBM-100 device as a useful, safe and accurate non-invasive method for measuring a wide range of Hct in both a hospital (e.g. surgery and blood transfusions) and ambulatory setting (e.g. blood banks). Good agreement was found between the non-invasive NBM-100 and the invasive Cell-Dyn Hct measurements. The non-invasive system was found to be environmentally - and user-friendly by the operating staff. These findings support the high clinical utility of a commercial application of the NBM-100 device.
Background: Non-Invasive Hematocrit (Hct) measurement devices have many potential advantages in primary and secondary medical situations. Primarily, these devices prevent the pain, the potential transmission of infectious diseases, and the need for trained technicians. However, truly non-invasive techniques have not been proven to be accurate enough to eliminate the need for blood sampling. A new, non-invasive clinical device, the NBM-100, was tested for accuracy. Aims: To examine the accuracy of Hct measurements obtained by a non-invasive clinical device as compared to values determined using venous samples. Methods: Clinical trials using the NBM–100 device were conducted in a blood donation center (USA) and a hematology clinic (Israel). The device utilizes a finger sensor with Occlusion Red/Near-InfraRed spectroscopy (O-RNIRS) technology to non-invasively measure hemoglobin and Hct levels. Studies were carried out on a group of 304 subjects (155 Female, 149 Male), ages 18–96 (average age 54.9). All study volunteers were tested non-invasively with the NBM-100 device, and invasively, using a venous sample evaluated on a Cell-Dyn (Abbott) blood analyzer. At the blood bank center, the NBM-100 measurements were performed before donation and the venous blood sample was taken after donation. To neutralize the decrease in Hct occurring during blood donation, as described in published clinical trials, a value of 2.2% was added to the reference venous values obtained from the blood bank center. Results: The venous Hct measurements ranged from 15 to 51%. The mean NBM-100 Hct (36%) was the same as the mean venous result. The standard deviation of the difference between the invasive and noninvasive Hct readings was found to be 3.34% and the bias was 0.40%. The mean absolute error (MAE) of their difference was 2.66%. The relative absolute error (RAE) was 7.9%. The operating staff at all centers found the NBM-100 easy to use and appreciated by subjects. Conclusions: This study indicates the potential use of the NBM-100 device as a useful and accurate non-invasive method for measuring a wide range of Hct in both a hospital (e.g. surgery and blood transfusions) and ambulatory setting (e.g. blood banks). Good agreement was found between the non-invasive NBM-100 and the invasive Cell-Dyn Hct measurements. The non-invasive system was found to be environmentally- and user-friendly by operating staff.
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