# Multiplex and multi-omic diagnostic test for bladder cancer recurrence

> **NIH NIH R44** · EARLY IS GOOD INC. · 2024 · $821,797

## Abstract

Following initial diagnosis and treatment, bladder cancer has a high recurrence rate, making it one of the most
expensive cancers to treat over a patient’s lifetime. The current standard of care testing for bladder cancer
recurrence is an invasive medical procedure, cystoscopy. Urine contains a wealth of biomarkers that can
potentially be used to monitor for signs of recurrence and early initiation of treatment. However, commercially
available biomarker-based bladder cancer tests rely on a single type of biomarker, are insufficiently sensitive,
often yield false negative and false positive results, and are time and resource intensive. Therefore, the
development of new approaches that afford high accuracy results are the key to improving patient care and
treatment. To meet this need, Early Is Good developed a bladder cancer diagnostic assay, called BCDx. BCDx
uses advanced nanotechnology to detect twelve different biomarkers directly from a urine sample. The
comprehensive approach is multi-omic multiplex because it measures the concentration of proteins, miRNAs,
mRNAs, and lncRNAs. Feasibility studies demonstrated attomolar sensitivity for each biomarker, with high
positive predictive and negative predictive values for biomarkers that are present in picomolar concentrations in
urine samples derived from healthy volunteers and bladder cancer patients. Moreover, BCDx can distinguish
healthy versus oncogenic samples and can discriminate between low grade and high-grade tumors. In a pilot
clinical study, BCDx demonstrated diagnostic feasibility, reliability, and validity. The goal of this proposal is to
execute a clinical validation study that is designed to complete the acquisition of data required by the FDA for
regulatory clearance through the 510(k) pathway. Beyond setting the state for regulatory clearance, Phase II
completion is expected to help promote the adoption of BCDx by clinicians and healthcare professionals and to
secure reimbursement from payers.

## Key facts

- **NIH application ID:** 10918479
- **Project number:** 1R44CA291290-01
- **Recipient organization:** EARLY IS GOOD INC.
- **Principal Investigator:** Thakshila Liyanage
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $821,797
- **Award type:** 1
- **Project period:** 2024-09-20 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10918479

## Citation

> US National Institutes of Health, RePORTER application 10918479, Multiplex and multi-omic diagnostic test for bladder cancer recurrence (1R44CA291290-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10918479. Licensed CC0.

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