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PointCheck, a novel technology for noninvasive, home-based neutropenia detection, can be safely and effectively operated by first-time users.
A mean system usability scale (SUS) score of 86.1 was obtained, indicating excellent perception of usability.
Boston, Massachusetts. Leuko (Leuko Labs Inc), a development-stage medical device company dedicated to creating noninvasive ways to monitor blood cells, today announced that data from its patient usability study (ClinicalTrials.gov NCT04448314) has been published in the Journal of Medical Internet Research.
“The publication of positive results from our study demonstrates the ease of use of PointCheck™. This study gives us confidence to embark on a registration study to confirm the performance and usability of PointCheck™,” said Carlos Castro Gonzalez, chief executive officer of Leuko. “Regular monitoring of severe neutropenia has the potential of providing better management of cancer patients. This study shows that PointCheck™, a developmental device for neutropenia monitoring, can be used with high levels of patient satisfaction in an unsupervised environment,” said Mark Sloan, MD, principal investigator, Boston Medical Center (BMC), Boston. “The usability of the device is equally high in patients enrolled in the study in Spain who could easily follow the instructions in Spanish,” said Joaquin Martinez-Lopez, MD, principal investigator at 12 de Octubre Hospital (H12O), Madrid, Spain.
This study, published in the Journal of Medical Internet Research, consisted of a total of 154 participants (85 patients with cancer receiving chemotherapy and 69 healthy volunteers). Patients were recruited at BMC and H12O before their routine chemotherapy administration. The healthy volunteers were recruited at the Massachusetts Institute of Technology’s Center for Clinical and Translational Research (Cambridge, Massachusetts). The study visits took place in a simulated home environment, and testing was conducted without supervision from a medical professional. No participants had prior experience with the tested device.
A subjective assessment of usability was performed on the basis of the SUS score—a Likert-type questionnaire was used, which consisted of 10 questions with 5 response options ranging from “strongly disagree” to “strongly agree.” The average SUS score across all participants was 86.1, placing PointCheck within the top 10th percentile of systems evaluated for usability. When stratifying the SUS results by education level, we found that the usability scores of participants above and below the eighth grade level were similar. Likewise, when stratifying by age category, we found that SUS scores of participants above and below 65 years of age were also very similar.
PointCheck, an investigational device, is the first noninvasive device designed to screen for severe neutropenia in the home setting. By imaging the blood flowing through the capillaries in the finger, PointCheck enables remote monitoring of white blood cell (WBC) levels based on optical imaging and without a blood draw. The device consists of an optics and illumination system, on-board computing electronics, a touch screen user interface, and disposable finger cartridges. It uses a camera microscopy system to image capillaries in the nail fold region of the finger. The videos of the capillary are analyzed by proprietary AI algorithms to monitor WBCs and determine if a patient has severe neutropenia. Currently, PointCheck has not yet been approved by any regulatory authority and is not for sale.
About Chemotherapy and Severe Neutropenia
One of the most serious side effects of cytotoxic chemotherapy is neutropenia, which refers to a decrease in neutrophils—the most common type of WBC and the most important cell needed to prevent bacterial infection. The primary clinical consequence of severe neutropenia is an elevated risk of life-threatening bacterial infection that typically requires immediate admission to the emergency room, hospitalization, and treatment. Every year, approximately 850,000 patients with cancer start chemotherapy treatments in the United States and 140,000 of them (17%) will endure at least one episode of febrile neutropenia (FN) or neutropenia accompanied by a fever. FN typically requires an admission of over 1 week, costing approximately US $46,000 per episode, with associated mortality rates between 7% and 10%. Timely detection and awareness of severe neutropenia (ie, an absolute neutrophil count of <500/µL) can be crucial to prevent and manage FN.
Leuko (Leuko Labs Inc) is an MIT spin-off company developing the world’s first noninvasive WBC monitoring device, which can be used at patients’ homes. Leuko is solving an unmet medical need of significantly reducing FN-related hospitalizations (n=140,000), which cost US $6.4 billion (US $46,000 per case) in the United States alone. At-home and frequent WBC monitoring would trigger timely interventions by the care team (eg, prophylactic antibiotics or growth colony–stimulating factors) that can reduce FN hospital readmissions by 50%. Our intellectual property portfolio includes 6 patents: 3 issued, 2 applications, and 1 provisional with both US and Patent Cooperation Treaty filings. We have submitted a 513g request for classification to the US Food and Drug Administration (FDA), which confirmed a Class II De Novo regulatory pathway. We have conducted a presubmission meeting with the FDA in which we agreed on the intent for use and design of the pivotal trial required for clearance, including sample size and performance targets. Our next step is to start a pivotal trial in which we will validate PointCheck in both patients with solid cancers and those with hematologic cancers. Beyond chemotherapy, Leuko aspires to continue growing to serve the more than 80 million immunocompromised patients worldwide, who could benefit from increased monitoring of their weakened immune system.
Lamaj G, Pablo-Trinidad A, Butterworth I, et al. Usability Evaluation of a Noninvasive Neutropenia Screening Device (PointCheck) for Patients Undergoing Cancer Chemotherapy: Mixed Methods Observational Study.
J Med Internet Res 2022;24(8):e37368
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