The National Cancer Institute (NCI), under the federal Cancer Detection and Diagnosis Research program (CFDA 93.394), awarded an $821,797 Project Grant to Early IS Good, Inc. to execute a clinical validation study for their BCDX bladder cancer diagnostic assay. BCDX uses advanced nanotechnology to detect 12 different biomarkers directly from a urine sample, providing a comprehensive, multi-omic, and multiplex approach to bladder cancer detection and recurrence monitoring. The 2-year project aims to complete the data acquisition required for FDA regulatory clearance through the 510(k) pathway, promoting BCDX's adoption by clinicians and securing reimbursement from payers. The award supports the continued development of this innovative bladder cancer diagnostic technology, which has demonstrated high sensitivity and the ability to distinguish healthy, low-grade, and high-grade bladder cancer samples in previous feasibility studies.
Mod # | Description | Reason For Modification | Federal Obligation (Click to sort descending) | Date (Click to sort ascending) |
|---|---|---|---|---|
| Not listed | $0 | 9/24/24 | ||
| Not listed | $821.8k | 9/20/24 |