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Reducing the incidence of febrile neutropenia in cancer patients treated with chemotherapy with PointCheck: a portable non-invasive neutropenia analyzer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA228920-02A1
Agency Tracking Number: R44CA228920
Amount: $1,988,315.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA19-272
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-07-01
Award End Date (Contract End Date): 2022-06-30
Small Business Information
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Cambridge, MA 02139-1499
United States
DUNS: 080809100
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (617) 952-1827
Business Contact
Phone: (617) 952-1827
Research Institution

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 (andlt;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.PROJECT NARRATIVE
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 patientsandapos; homes, will provide early detection and
enable prompt medical care to prevent life-threatening infections in cancer patients undergoing chemotherapy.

* Information listed above is at the time of submission. *

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