The goal of this Phase II SBIR project is to optimize and validate PointCheck, the first non-invasive point-of-care (POC) device that identifies patients undergoing cancer chemotherapy who have early- stage febrile neutropenia and need immediate treatment to prevent serious infections. Every year in the US, 650,000 cancer patients are treated with chemotherapy. One side effect of treatment is neutropenia, a life- threatening condition caused by low levels of neutrophils that leads to hospitalization, increased risk of mortality and total associated costs of $2.7B annually. PointCheck uses noninvasive optical imaging of microcirculation in nailfold capillaries to detect severe neutropenia without the need for a blood sample. It is intended for use by cancer patients undergoing chemotherapy, in order to identify patients with neutropenia who require prompt treatment to avoid serious infections, hospital readmission costs and morbidity. Because it is self-contained and does not require blood sampling or reagents, it ultimately may be used by patients at home to monitor blood counts between chemotherapy sessions. In Phase I of this project, Leuko Labs successfully: (1) automated the selection of suitable capillaries from raw videos; (2) automated the detection of flow gaps that indicate passage of neutrophils in nail-fold capillaries; and (3) automatically analyzed manually-collected 1-min videos of nailfold capillaries from 44 cancer chemotherapy patients and identified those with grade IV neutropenia (<500 neutrophils/mm3) with an excellent classification performance (AUC=0.95). The objective of this Phase II project is to complete the next steps to bring PointCheck to market by designing a production-ready PointCheck device and validating it in a clinical study to support the filing of a Class II De Novo approval to the FDA.
Aim 1 is to design a production-ready PointCheck hardware prototype for unsupervised use by patients by miniaturizing the optical components.
Aim 2 is to develop and integrate the image analysis software pipeline to the production-ready unit.
Aim 3 is to complete an initial pilot usability study performed in 3 cohorts of 30 patients (n=90 total) as the device is optimized in Aims 1 and 2; this study will also confirm that PointCheck is ready for the pivotal clinical study in Aim 4.
Aim 4 is to complete a pivotal clinical study to validate PointCheck in a clinical diagnostic study (n=100) to confirm that grade IV neutropenia can be identified safely and effectively.
Aim 5 is to submit a Class II De Novo approval package to the FDA. Successful completion of this Phase II project will fulfill the requirements for a minimum viable product and enable initial commercialization of this first-in-kind technology to improve the management of febrile neutropenia in cancer patients undergoing chemotherapy.
PointCheck is a self-administered portable point-of-care optical imaging device that noninvasively detects immunosuppression resulting from cancer chemotherapy, without the need for a blood sample. Use of PointCheck in outpatient cancer clinics, and ultimately in patients' homes, will provide early detection and enable prompt medical care to prevent life-threatening infections in cancer patients undergoing chemotherapy.
