5 Aptamer-Based Medical Devices
119
With the aid of SomaScan® Assay, Washington University School of Medicine,
collaborated with American College of Gastroenterology, conducted a clinical
research named “Triangular Phenotyping and Response Assessment in Small Bowel
(SB) Crohn’s Disease (CD) Using Magnetic Resonance Enterography (MRE) and
Novel Proteomic Biomarkers,” briefly, “Response Assessment in SB CD” since May
2018 [16]. The overall objective of this proposal was to establish radiologic transmural response and a novel proteomic biomarker that could accurate and clinically
meaningful predict the small bowel Crohn’s Disease (SBCD) inflammatory activity.
Serum proteomic biomarker profiles were evaluated using SomaScan® Assay, a
novel aptamer-based platform that offering high-throughput analysis of proteins
through Slow Off-rate Modified DNA Aptamer (SOMAmer)-based capture array.
The experimental data using SomaScan® Assay identified that week 14 clinical
remission in SBCD patients could be predicted through a group of 12 serum proteins
whose differential expression pattern from week 0 to week 6. The significance of
this proposal is that the development of an early predictive model using radiological
and serum endpoints will facilitate a personalized algorithmic approach to identify patients with SBCD. Furthermore, it will be used to generate a tangible tool
of a prospectively enrolled patient cohort to further study radiologic and biomarker
predictors of response in SBCD.
Jaime Landman, University of California, Irvine, launched another clinical trial
on “Molecular Biosensors for Detection of Bladder Cancer” since June 2015 [17].
The aim of this study was to develop electro-phage and colorimetric aptamer-based
sensors for clinical staging and further monitor bladder cancer. This study focused on
the identification of urinary biomarkers that were distinct to those of bladder cancer
and the development of molecular sensors that could detect urinary abnormalities.
The biomarker discovery and sensor development would proceed simultaneously by
applying in vitro selection techniques. In the clinical experiments, the urine from
the patients was collected and used in vitro as a medium for phage and aptamer
production. The generated molecular probes would be used to evaluate and elucidate
biomarkers in patients with bladder cancer. The experimental group included the
patients who were being monitored for bladder cancer, and they would be tested via
the electro-phage and aptamer approach to follow the bladder cancer biomarkers.
Negative control group were the patients being treated for hematuria providing data
from determination of biomarkers in the patients treated for other diseases.
Sypabekova et al. [18] presented results on the development of the aptasensor for
the detection of MPT64, a Mycobacterium tuberculosis secreted protein, for tuberculosis (TB) diagnosis. This aptasensor used electrochemical impedance spectroscopy
as determination method. The MPT64 aptamers were immobilized on an interdigitated electrode (Fig. 5.2). The developed aptasensor was validated on clinical samples
from TB(+) and TB(−) patients with specificity and sensitivity for the serum sample
analysis 100% and 88.24%, respectively, and for the sputum sample analysis 100%
and 76.47%, respectively. This study demonstrated that the above aptasensing platforms could be successfully employed in clinical sample analysis, with the aim to
exploit the advantages of this method for aptamer-based medical device.
119
With the aid of SomaScan® Assay, Washington University School of Medicine,
collaborated with American College of Gastroenterology, conducted a clinical
research named “Triangular Phenotyping and Response Assessment in Small Bowel
(SB) Crohn’s Disease (CD) Using Magnetic Resonance Enterography (MRE) and
Novel Proteomic Biomarkers,” briefly, “Response Assessment in SB CD” since May
2018 [16]. The overall objective of this proposal was to establish radiologic transmural response and a novel proteomic biomarker that could accurate and clinically
meaningful predict the small bowel Crohn’s Disease (SBCD) inflammatory activity.
Serum proteomic biomarker profiles were evaluated using SomaScan® Assay, a
novel aptamer-based platform that offering high-throughput analysis of proteins
through Slow Off-rate Modified DNA Aptamer (SOMAmer)-based capture array.
The experimental data using SomaScan® Assay identified that week 14 clinical
remission in SBCD patients could be predicted through a group of 12 serum proteins
whose differential expression pattern from week 0 to week 6. The significance of
this proposal is that the development of an early predictive model using radiological
and serum endpoints will facilitate a personalized algorithmic approach to identify patients with SBCD. Furthermore, it will be used to generate a tangible tool
of a prospectively enrolled patient cohort to further study radiologic and biomarker
predictors of response in SBCD.
Jaime Landman, University of California, Irvine, launched another clinical trial
on “Molecular Biosensors for Detection of Bladder Cancer” since June 2015 [17].
The aim of this study was to develop electro-phage and colorimetric aptamer-based
sensors for clinical staging and further monitor bladder cancer. This study focused on
the identification of urinary biomarkers that were distinct to those of bladder cancer
and the development of molecular sensors that could detect urinary abnormalities.
The biomarker discovery and sensor development would proceed simultaneously by
applying in vitro selection techniques. In the clinical experiments, the urine from
the patients was collected and used in vitro as a medium for phage and aptamer
production. The generated molecular probes would be used to evaluate and elucidate
biomarkers in patients with bladder cancer. The experimental group included the
patients who were being monitored for bladder cancer, and they would be tested via
the electro-phage and aptamer approach to follow the bladder cancer biomarkers.
Negative control group were the patients being treated for hematuria providing data
from determination of biomarkers in the patients treated for other diseases.
Sypabekova et al. [18] presented results on the development of the aptasensor for
the detection of MPT64, a Mycobacterium tuberculosis secreted protein, for tuberculosis (TB) diagnosis. This aptasensor used electrochemical impedance spectroscopy
as determination method. The MPT64 aptamers were immobilized on an interdigitated electrode (Fig. 5.2). The developed aptasensor was validated on clinical samples
from TB(+) and TB(−) patients with specificity and sensitivity for the serum sample
analysis 100% and 88.24%, respectively, and for the sputum sample analysis 100%
and 76.47%, respectively. This study demonstrated that the above aptasensing platforms could be successfully employed in clinical sample analysis, with the aim to
exploit the advantages of this method for aptamer-based medical device.