# Development of a Colorimetric Sensor for Detection of Cerebrospinal Fluid Leaks

> **NIH NIH R44** · DRINKSAVVY, INC. · 2024 · $840,440

## Abstract

PROJECT SUMMARY
Chemeleon, Inc. is a NYC-based startup that is developing a novel colorimetric biosensor that rapidly diagnoses
cerebrospinal fluid (CSF) leaks at the Point-of-Care (POC), such as by doctors to diagnose Traumatic Brain
Injury (TBI) patients in the Emergency Department (ED), or the Emergency Medical Technician (EMT) in the
ambulance, or during intraoperative and post-operative care for spinal and otolaryngological surgeries. CSF
leaks occur when the fluid that cushions the brain and spine escapes through ruptures in the surrounding
membranes. These leaks are largely caused by TBIs but are also a risk during spinal surgeries, otolaryngological
surgeries, lumbar punctures and epidurals and they can also be spontaneous. Distinguishing CSF leaks from
other bodily fluids is a well-known problem for ED doctors, EMTs and surgeons as the leaks often present as
unilateral rhinorrhea or otorrhea, a clear watery discharge from the nose or ear, or as a mixture with blood and
other fluids during spinal surgery. Currently there are no POC diagnostics for CSF leaks and existing methods
require patient samples to be sent to third-party laboratories for results that can take 4-7 days. Treatment delays
or misdiagnoses significantly increase the risk for life-threatening meningitis, infections and stroke. Patients with
CSF rhinorrhea that develop meningitis have also have much higher morbidity rates. Additionally, the weeklong
stay not only causes significant distress and discomfort for the patient, but also leads to radically higher
healthcare costs. In this Direct-to-Phase II proposal, Chemeleon aims to advance CSF leak diagnosis by
developing a novel, inexpensive biosensor that requires no additional equipment or personnel training that can
provide results in minutes, enabling medical professionals to make time-sensitive decisions. Chemeleon has
already successfully developed a prototype Binding-Induced Nanostructured Dynamic Surface (BINDS) Assay
that binds the CSF protein biomarker, beta-2-transferrin (b2TR). This BINDS platform technology integrates
nanophotonic reporter surfaces with b2TR-specific aptamer receptors, where binding of b2TR to the sensor
surface alters the surface energy producing a vibrant color change that is visible to the naked eye. Proof-of-
concept experiments revealed that Chemeleon’s BINDS CSF assay could detect 1 µg/ml of b2TR in 10 minutes,
which is higher than the 4-5 µg/ml found in CSF. For Direct-to-Phase II studies, the CSF sensor will be further
developed to achieve the high specificity, high sensitivity and low readout time required for use in clinical and
field settings. Chemeleon will focus on (1) optimizing sensor performance to rapidly distinguish CSF from nasal
fluid and blood samples, (2) finalizing manufacturing processes for efficient scale-up, and (3) designing and
testing a commercial in vitro diagnostic prototype. Chemeleon’s CSF sensor will provide advancements in
decision-making for head trauma, spina...

## Key facts

- **NIH application ID:** 10758856
- **Project number:** 5R44NS130769-02
- **Recipient organization:** DRINKSAVVY, INC.
- **Principal Investigator:** Min Hu
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $840,440
- **Award type:** 5
- **Project period:** 2023-01-02 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10758856

## Citation

> US National Institutes of Health, RePORTER application 10758856, Development of a Colorimetric Sensor for Detection of Cerebrospinal Fluid Leaks (5R44NS130769-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10758856. Licensed CC0.

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