SBIR-STTR Award

Chemeleon, Inc. is a NYC-based startup that is developing a novel colorimetric biosensor that rapidly diagnosescerebrospinal fluid (CSF) leaks at the Point-of-Care (POC), such as by doctors to diagnose Traumatic BrainInjury (TBI) patients in the Emergency Department (ED), or the Emergency Medical Technician (EMT) in theambulance, or during intraoperative and post-operative care for spinal and otolaryngological surgeries. CSFleaks occur when the fluid that cushions the brain and spine escapes through ruptures in the surroundingmembranes. These leaks are largely caused by TBIs but are also a risk during spinal surgeries, otolaryngologicalsurgeries, lumbar punctures and epidurals and they can also be spontaneous. Distinguishing CSF leaks fromother bodily fluids is a well-known problem for ED doctors, EMTs and surgeons as the leaks often present asunilateral rhinorrhea or otorrhea, a clear watery discharge from the nose or ear, or as a mixture with blood andother fluids during spinal surgery. Currently there are no POC diagnostics for CSF leaks and existing methodsrequire patient samples to be sent to third-party laboratories for results that can take 4-7 days. Treatment delaysor misdiagnoses significantly increase the risk for life-threatening meningitis, infections and stroke. Patients withCSF rhinorrhea that develop meningitis have also have much higher morbidity rates. Additionally, the weeklongstay not only causes significant distress and discomfort for the patient, but also leads to radically higherhealthcare costs. In this Direct-to-Phase II proposal, Chemeleon aims to advance CSF leak diagnosis bydeveloping a novel, inexpensive biosensor that requires no additional equipment or personnel training that canprovide results in minutes, enabling medical professionals to make time-sensitive decisions. Chemeleon hasalready successfully developed a prototype Binding-Induced Nanostructured Dynamic Surface (BINDS) Assaythat binds the CSF protein biomarker, beta-2-transferrin (b2TR). This BINDS platform technology integratesnanophotonic reporter surfaces with b2TR-specific aptamer receptors, where binding of b2TR to the sensorsurface 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 furtherdeveloped to achieve the high specificity, high sensitivity and low readout time required for use in clinical andfield settings. Chemeleon will focus on (1) optimizing sensor performance to rapidly distinguish CSF from nasalfluid and blood samples, (2) finalizing manufacturing processes for efficient scale-up, and (3) designing andtesting a commercial in vitro diagnostic prototype. Chemeleon's CSF sensor will provide advancements indecision-making for head trauma, spinal and otolaryngological surgical cases and present a modular platformfor the development of other healthcare diagnostics.

Public Health Relevance Statement:
PROJECT NARRATIVE Cerebrospinal fluid (CSF) leaks occur when the protective fluid surrounding the brain and spine escapes through tears caused during traumatic brain injuries, spinal surgeries and otolaryngological surgeries and, if left undiagnosed, increase a patient's risk for infections, meningitis, stroke and death. Chemeleon, Inc. is developing an easy-to-use colorimetric biosensor that rapidly changes color in minutes in the presence of CSF, a significant advancement from current detection technologies which require sending samples to external labs for results in 4-7 days. Chemeleon's CSF biosensor will be operated by physicians and EMTs at the point-of-care, providing near-instantaneous results to help prevent future complications and improve patient outcomes.

Project Terms:

Chemeleon, Inc. is a NYC-based startup that is developing a novel colorimetric biosensor that rapidly diagnosescerebrospinal fluid (CSF) leaks at the Point-of-Care (POC), such as by doctors to diagnose Traumatic BrainInjury (TBI) patients in the Emergency Department (ED), or the Emergency Medical Technician (EMT) in theambulance, or during intraoperative and post-operative care for spinal and otolaryngological surgeries. CSFleaks occur when the fluid that cushions the brain and spine escapes through ruptures in the surroundingmembranes. These leaks are largely caused by TBIs but are also a risk during spinal surgeries, otolaryngologicalsurgeries, lumbar punctures and epidurals and they can also be spontaneous. Distinguishing CSF leaks fromother bodily fluids is a well-known problem for ED doctors, EMTs and surgeons as the leaks often present asunilateral rhinorrhea or otorrhea, a clear watery discharge from the nose or ear, or as a mixture with blood andother fluids during spinal surgery. Currently there are no POC diagnostics for CSF leaks and existing methodsrequire patient samples to be sent to third-party laboratories for results that can take 4-7 days. Treatment delaysor misdiagnoses significantly increase the risk for life-threatening meningitis, infections and stroke. Patients withCSF rhinorrhea that develop meningitis have also have much higher morbidity rates. Additionally, the weeklongstay not only causes significant distress and discomfort for the patient, but also leads to radically higherhealthcare costs. In this Direct-to-Phase II proposal, Chemeleon aims to advance CSF leak diagnosis bydeveloping a novel, inexpensive biosensor that requires no additional equipment or personnel training that canprovide results in minutes, enabling medical professionals to make time-sensitive decisions. Chemeleon hasalready successfully developed a prototype Binding-Induced Nanostructured Dynamic Surface (BINDS) Assaythat binds the CSF protein biomarker, beta-2-transferrin (b2TR). This BINDS platform technology integratesnanophotonic reporter surfaces with b2TR-specific aptamer receptors, where binding of b2TR to the sensorsurface 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 furtherdeveloped to achieve the high specificity, high sensitivity and low readout time required for use in clinical andfield settings. Chemeleon will focus on (1) optimizing sensor performance to rapidly distinguish CSF from nasalfluid and blood samples, (2) finalizing manufacturing processes for efficient scale-up, and (3) designing andtesting a commercial in vitro diagnostic prototype. Chemeleon's CSF sensor will provide advancements indecision-making for head trauma, spinal and otolaryngological surgical cases and present a modular platformfor the development of other healthcare diagnostics.

Public Health Relevance Statement:
PROJECT NARRATIVE Cerebrospinal fluid (CSF) leaks occur when the protective fluid surrounding the brain and spine escapes through tears caused during traumatic brain injuries, spinal surgeries and otolaryngological surgeries and, if left undiagnosed, increase a patient's risk for infections, meningitis, stroke and death. Chemeleon, Inc. is developing an easy-to-use colorimetric biosensor that rapidly changes color in minutes in the presence of CSF, a significant advancement from current detection technologies which require sending samples to external labs for results in 4-7 days. Chemeleon's CSF biosensor will be operated by physicians and EMTs at the point-of-care, providing near-instantaneous results to help prevent future complications and improve patient outcomes.

Project Terms: