Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients

The Sponsor aims to describe the incidence of positivity for fungal specific pathogens on NGS
analysis in a high-risk immunocompromised pediatric population.

Secondarily, the Sponsor will correlate results of the NGS analysis to other approved fungal
tests if performed at the discretion of the treating provider (e.g. blood culture results,
radiographic findings, biopsy results, bronchoalveolar lavage findings, galactomannan results
or b-D-glucan (BG) results as evaluated via FDA-approved "Fungitell" assay). The Sponsor will
use these other fungal tests, in addition to clinical criterion, to classify subjects as
having possible, probable and proven IFD according to established criteria, and compare these
categories against results from NGS analysis.

Lastly, to quantitatively evaluate follow-up test results to determine fungal DNA genomic
load in subjects with positive results.

Inclusion Criteria:

- Prolonged FN (≥96 hours) despite broad-spectrum antibiotic therapy with anticipated
delayed neutrophil recovery

- Any findings that trigger the primary team to consider new fungal infection in a given
inpatient, such as abnormal imaging results, recrudescent fevers in the setting of
neutropenia or characteristic skin rashes

Exclusion Criteria:

-Those without concern for fungal infection or those currently being treated for a presumed
or documented fungal infection will not be recruited for this study