LEUKO LABS, INC — Department of Health and Human Services SBIR Phase I: 396

Description

Every year in the UScancer patients are treated with chemotherapyAs a side effecttheir neutrophil countsnumber of white blood cells that aid in fighting infectionsbecome lowreferred to as neutropeniaand expose them to febrile neutropeniaFNwhich are episodesof serious infection that entail costly hospitalization and sometimes deathIfneutropenia is detected earlyFN can be avoided through timely delivery ofprophylactic antibiotics or growth stimulating factorsCurrentlyneutrophil measurements requirevisits to healthcare centersThis increases infection riskas measurements are taken infrequentlyand low counts may not be detected before infections ensueand reduces chemotherapy efficacyaschemotherapy levels are kept at the lower end of frequency and dose for safetyWe aim to overcomethis limitation with PointChecka noninvasive neutrophil test that can be used frequently inlocal health centers or at homeenabling physicians to minimize infections andpersonalize chemotherapy planningThe basis for our technology is noninvasive optical imaging ofmicrocirculation in nailfold capillariesWe conducted a pilot clinical study where trainednurses used PointCheck to acquire data fromchemotherapy patientsBy manually analyzinga training datasetNmeasurements frompatientswe built a labeled dataset of flow gaps inthe microcirculation that can be considered proxies of neutrophils and demonstrated their numbercan be used to distinguish baseline patientsandgtneutrophils mmfrom grade IV neutropenic onesandltmmHoweverthe need for manual analysis makes the technology inaccessible to patients onits current statusWith support from SBIR Phase Iwe willadevelop algorithms that automatizethe manual data processing workflow employed on our training setbtest those algorithms on ouracquired and unanalyzed testing databaseNmeasurements frompatientsandcgenerateadditional performance data including further intermediate neutrophil rangesandgtand andltneutrophils mmthus fulfilling the requirements for a minimum viable productThe consecution ofthese milestones will enablein Phase IIusing PointCheck in a multi site diagnostic validationtrial to confirmunder clinical conditionsthat the management of FN can be improved with thisnew paradigm Development of a portable optical imaging device that can noninvasivelydetect neutropenia related immunosuppressionto enable more frequent monitoring ofchemotherapy patients so that timely medical interventions can be staged beforelife threatening infections develop