PixCell Medical,Yokneam Ilit, Israel, and Interreg Germany-Denmark’s Changing Cancer Care initiative are collaborating to assess the ability of PixCell’s HemoScreen hematology analyzer to enable home-based testing of blood values. It is hoped the analyzer will support treatment of cancer patients in homecare settings, thereby limiting immunocompromised patients’ exposure to contagion in a hospital.
Through the study, patients will be trained to use the HemoScreen system to perform a five-part complete blood count (CBC), as required to manage patients’ oncology therapy treatments and support clinical decision-making.
Healthcare professionals rely on test readings—including absolute neutrophil count, hemoglobin, platelet levels, and total white blood cell count—to make determinations about their patients’ treatment plans. HemoScreen allows the process to take place within 6 minutes, providing results for 20 standard CBC parameters. The goal will be to enable patients to safely and routinely test their blood levels at home.
Though HemoScreen is CE-marked and FDA-cleared for point-of-care use, it is not yet approved for home use—though it will be used this way in a research capacity through the study.
“We needed a simple, intuitive, and portable device that was easy to operate and could provide both rapid and accurate results,” says Ditte Luise Hartvig, project manager in the department of research projects and clinical optimization at Zealand University Hospital. “HemoScreen fulfilled these criteria, offered the sophisticated CBC analysis required to meet the monitoring needs of clinicians, and also met the ease-of-use and portability criteria for our patients to participate in this study from their homes.”
Led by the department for research projects and clinical optimization at Zealand University Hospital, the study will include three phases:
- Phase 1 (to be completed May 2020): HemoScreen is currently being tested within the hospital’s clinical biochemistry department, where researchers have been performing validation assessments on measurement accuracy as well as the system’s usability.
- Phase 2 (to be completed by September 2020): Staff of the hospital’s clinical oncology department will be trained, and additional usability testing will be performed for the HemoScreen system. Patients will then be trained on using HemoScreen to ensure safe use of the capillary self-testing device by patients before initiating phase 3.
- Phase 3 (to be completed by December 2021): Researchers will assess the feasibility of having oncology patients who are receiving chemotherapy utilize HemoScreen to perform CBC monitoring assessment from home.
To simplify blood testing, HemoScreen uses a disposable cartridge that includes all necessary reagents and requires no maintenance or calibration. HemoScreen’s underlying technology, viscoelastic focusing, is a patent-protected physical phenomenon that causes cells to perfectly align into a single layer, facilitating their rapid analysis.
“HemoScreen could save precious time for patients and healthcare systems. Currently, ill patients must travel to clinical centers for blood tests, not knowing if they are ready for treatment, spending hours waiting for their CBC result, only to be told that they aren’t ready yet,” says Niels Henrik Holländer, MD, a clinical oncologist and leader of Changing Cancer Care at Zealand University Hospital. “With HemoScreen, we can potentially save patients significant time and energy exertion when undergoing these serious treatments, and also save time and costs for hospitals.”
“Patients receiving oncology therapies are immunocompromised and susceptible to infection,” says Avishay Bransky, PhD, chief executive officer of PixCell Medical. “A hospital environment presents a major risk, due to potential contact with other patients and staff and for hospital-acquired infection. As such, we believe that enabling the shift to home-care settings for oncology, in particular, is a crucial evolution in cancer care. Giving patients the ability to use HemoScreen for CBC at home could be the next revolutionary evolution enabling at-home oncology treatment.”