Researchers develop low-cost device that detects cancer in an hour | ScienceDaily
Summary
Key Features:
- Low cost (a few dollars per device, <8 cents per assay)
- Provides results in about 1 hour (vs. 12-16 hours for traditional methods)
- Approximately 10 times more sensitive than traditional methods
- Portable and doesn't require specialized instruments
- Can detect both CEA colorectal and PSA prostate cancer biomarkers
- Uses a "paper-in-polymer-pond" structure to analyze blood samples
How it works:
- Uses microfluidic technology to test small amounts of fluid
- Blood samples are placed on special paper within tiny wells
- The paper captures cancer protein biomarkers and changes color
- Color intensity indicates cancer type and progression
Advantages over current methods:
- Traditional ELISA testing requires expensive equipment and long processing times
- Particularly beneficial for developing countries and rural areas where access to specialized testing facilities is limited
- Can detect smaller quantities of cancer biomarkers, enabling earlier detection
Current Status:
- Still requires clinical trials and FDA approval before public availability
- Could potentially be adapted for other types of cancer
- Development process may take several years
The research team believes this innovation could significantly improve cancer detection in resource-limited settings, potentially leading to better patient outcomes through earlier diagnosis.
Clinical Impact
Advantages for Initial Screening:
1. Increased Accessibility- - Lower cost per test could enable more widespread screening programs
- - Portable nature allows for testing in primary care offices, rural clinics, and remote locations
- - Could reduce disparities in cancer screening access
- - Detection of cancers at earlier stages
- - More accurate monitoring of disease progression
- - Better survival rates through earlier intervention
- - Reduced false negatives
- - Same-day diagnosis and treatment planning
- - Reduced patient anxiety waiting for results
- - Faster referral to specialists when needed
- - More efficient clinical workflows
Impact on Clinical Practice:
1. Primary Care Settings
- - Could shift initial screening from specialty centers to primary care
- - Enables point-of-care testing during routine visits
- - May improve screening compliance due to convenience
- - Could reduce referrals for negative cases
- - Reduced laboratory costs
- - Less specialized equipment needed
- - More efficient use of healthcare personnel
- - Potential reduction in unnecessary specialist referrals
- - Could significantly improve access to screening
- - Reduction in travel time/costs for patients
- - Earlier detection in populations that typically present with later-stage disease
- - Better alignment with WHO's goals for global cancer control
- - Easier frequent testing for high-risk patients
- - More consistent monitoring of disease progression
- - Better tracking of treatment response
- - Simplified active surveillance protocols
- Need for validation against current gold standards
- Training requirements for proper use and interpretation
- Integration with existing clinical workflows
- Need for clear guidelines on result interpretation
- Establishing appropriate follow-up protocols for positive results
Clinical Status and Development Timeline
Current Status:
- - Proof-of-concept demonstrated
- - Initial testing completed on spiked serum samples
- - Shows promising sensitivity: LOD of 0.32 ng/mL for CEA and 0.20 ng/mL for PSA
- - Basic prototype functionality proven in lab setting
Development Path and Timeline:
1. Pre-Clinical Phase (1-2 years):- - Optimization of device design for manufacturing
- - Validation studies with larger sample sets
- - Stability testing and shelf-life determination
- - Development of quality control processes
- - Standardization of manufacturing procedures
- - Initial small-scale clinical trials
- - Testing with actual patient samples (not just spiked samples)
- - Validation against current gold standard methods
- - Multi-center studies for reproducibility
- - Collection of data for FDA submission
- - Development of mass production processes
- - Quality control systems implementation
- - Supply chain establishment
- - Cost optimization
- - Production facility setup
- - FDA submission and review
- - Addressing any FDA feedback
- - Clinical validation data review
- - Manufacturing process validation
- - Obtaining necessary certifications
- - Healthcare provider training programs
- - Distribution network establishment
- - Clinical implementation protocols
- - Reimbursement pathway development
Key Considerations:
- Timeline could be shortened if device qualifies for expedited FDA review
- Being a diagnostic rather than therapeutic device may simplify some regulatory requirements
- The low cost and simple design may accelerate manufacturing setup
- Additional validation may be needed for use in resource-limited settings
The papers indicate that while the technology is promising, several steps including "further validation using clinical samples in real-world clinical settings" are still needed before commercial deployment.
Commercial Exploitation
The research has been conducted at the University of Texas at El Paso, with the following relevant details about potential commercialization:
Key Points:
- Patent Status:
- The researchers (XL and SST) have submitted a patent application for the technology, as noted in the "Conflicts of interest" section
- Current Institutional Support:
- Research funding has come from academic and government sources including:
- Cancer Prevention and Research Institute of Texas (CPRIT)
- NIH/NIAID
- U.S. NSF
- Medical Center of the Americas Foundation (MCA)
- University of Texas System
- Principal Investigators:
- Dr. XiuJun (James) Li - Lead researcher at University of Texas at El Paso
- Sanjay S. Timilsina - Co-researcher
While no commercial partnerships are mentioned, the combination of:
- Patent filing
- Multiple funding sources
- Low manufacturing costs
- Clear clinical application suggests the technology may be positioned for commercial development, possibly through a university spin-off or licensing to an established diagnostic company.
Researchers at The University of Texas at El Paso have created a portable device that can detect colorectal and prostate cancer more cheaply and quickly than prevailing methods. The team believes the device may be especially helpful in developing countries, which experience higher cancer mortality rates due in part to barriers to medical diagnosis.
"Our new biochip device is low-cost -- just a few dollars -- and sensitive, which will make accurate disease diagnosis accessible to anyone, whether rich or poor," said XiuJun (James) Li, Ph.D., a UTEP professor of chemistry and biochemistry. "It is portable, rapid and eliminates the need for specialized instruments."
Li is the lead author on a new study describing the device; it's published in Lab on a Chip, a journal that focuses on micro-scale and nanoscale devices.
Li explained that the most commonly used commercial method of cancer biomarker detection, known as ELISA, requires costly instrumentation to work correctly and can take twelve hours or longer to process a sample. This delay is heightened in rural areas in the U.S. or developing countries, he said, because patient samples must be transported to larger cities with specialized instruments, contributing to a higher rate of cancer mortality.
"If you can detect biomarkers early on, before the cancer spreads, you increase a patients' chance of survival," Li said. "Any delays in testing, especially in regions that don't have access to expensive tools and instruments, can be very bad for a patient's prognosis."
The device that Li's team created is microfluidic, which means that it can perform multiple functions using very small amounts of fluids. The device uses an innovative 'paper-in-polymer-pond' structure in which patient blood samples are introduced into tiny wells and onto a special kind of paper. The paper captures cancer protein biomarkers within the blood samples in just a few minutes. The paper subsequently changes color, and the intensity of the color indicates what type of cancer is detected and how far it has progressed.
So far, the research has focused on prostate and colorectal cancers, but Li said the method they devised could be applicable to a wide variety of cancer types.
Li said that the device can analyze a sample in an hour -- compared to 16 hours using some traditional methods. According to study results, the device is also about 10 times more sensitive than traditional methods even without using specialized instruments. That means the device can detect cancer biomarkers that are present in smaller quantities, typical of cancer in its early stages. A less sensitive device may not pick up on the smaller quantities, Li said.
Before the device is available to the public, Li said the prototype of the device will need to be finalized and the device tested on patients in a clinical trial, which could take several years. It would require final approval by the Food and Drug Administration before it could be used by physicians.
"Dr. XiuJun Li's innovation significantly improves point-of-care diagnostics by reducing detection times and the need for costly instruments," said Robert Kirken, dean of the College of Science. "This makes it ideal for resource-limited settings, which will improve early diagnosis and lead to better cancer outcomes. I look forward to seeing what this innovation leads to."
An additional co-author on the study is Sanjay Timilsina, Ph.D., a former graduate research assistant at UTEP. Li is a member of the Lab on a Chip advisory board.
UTEP Researchers Develop Low-Cost Device that Detects Cancer in an Hour
Particularly beneficial for rural U.S. areas, developing countries
EL PASO, Texas (Oct. 24, 2024) – Researchers at The University of Texas at El Paso have created a portable device that can detect colorectal and prostate cancer more cheaply and quickly than prevailing methods. The team believes the device may be especially helpful in developing countries, which experience higher cancer mortality rates due in part to barriers to medical diagnosis.
A team of UTEP researchers led by Xiujun (James) Li, Ph.D., have created a low-cost, portable device that can detect colorectal and prostate cancer in as little as one hour.
“Our new biochip device is low-cost — just a few dollars — and sensitive, which will make accurate disease diagnosis accessible to anyone, whether rich or poor,” said XiuJun (James) Li, Ph.D., a UTEP professor of chemistry and biochemistry. “It is portable, rapid and eliminates the need for specialized instruments.”
Li is the lead author on a new study describing the device; it’s published in Lab on a Chip, a journal that focuses on micro-scale and nanoscale devices.
Li explained that the most commonly used commercial method of cancer biomarker detection, known as ELISA, requires costly instrumentation to work correctly and can take twelve hours or longer to process a sample. This delay is heightened in rural areas in the U.S. or developing countries, he said, because patient samples must be transported to larger cities with specialized instruments, contributing to a higher rate of cancer mortality.
“If you can detect biomarkers early on, before the cancer spreads, you increase a patients’ chance of survival,” Li said. “Any delays in testing, especially in regions that don’t have access to expensive tools and instruments, can be very bad for a patient’s prognosis.”
The device that Li’s team created is microfluidic, which means that it can perform multiple functions using very small amounts of fluids. The device uses an innovative ‘paper-in-polymer-pond’ structure in which patient blood samples are introduced into tiny wells and onto a special kind of paper. The paper captures cancer protein biomarkers within the blood samples in just a few minutes. The paper subsequently changes color, and the intensity of the color indicates what type of cancer is detected and how far it has progressed.
So far, the research has focused on prostate and colorectal cancers, but Li said the method they devised could be applicable to a wide variety of cancer types.
Li said that the device can analyze a sample in an hour — compared to 16 hours using some traditional methods. According to study results, the device is also about 10 times more sensitive than traditional methods even without using specialized instruments. That means the device can detect cancer biomarkers that are present in smaller quantities, typical of cancer in its early stages. A less sensitive device may not pick up on the smaller quantities, Li said.
Before the device is available to the public, Li said the prototype of the device will need to be finalized and the device tested on patients in a clinical trial, which could take several years. It would require final approval by the Food and Drug Administration before it could be used by physicians.
“Dr. XiuJun Li's innovation significantly improves point-of-care diagnostics by reducing detection times and the need for costly instruments,” said Robert Kirken, dean of the College of Science. “This makes it ideal for resource-limited settings, which will improve early diagnosis and lead to better cancer outcomes. I look forward to seeing what this innovation leads to.”
An additional co-author on the study is Sanjay Timilsina, Ph.D., a former graduate research assistant at UTEP. Li is a member of the Lab on a Chip advisory board.
About The University of Texas at El Paso
The University of Texas at El Paso is America’s leading Hispanic-serving university. Located at the westernmost tip of Texas, where three states and two countries converge along the Rio Grande, 84% of our 24,000 students are Hispanic, and more than half are the first in their families to go to college. UTEP offers 170 bachelor’s, master’s and doctoral degree programs at the only open-access, top-tier research university in America.
Last Updated on October 24, 2024 at 12:00 AM | Originally published October 24, 2024
By MC Staff UTEP Marketing and Communications
Sanjay S. Timilsina, XiuJun Li. A paper-in-polymer-pond (PiPP) hybrid microfluidic microplate for multiplexed ultrasensitive detection of cancer biomarkers. Lab on a Chip, 2024; 24 (21): 4962 DOI: 10.1039/D4LC00485J
A paper-in-polymer-pond (PiPP) hybrid microfluidic microplate for multiplexed ultrasensitive detection of cancer biomarkers†
*ab
Abstract
Conventional affinity-based colorimetric enzyme-linked immunosorbent assay (ELISA) is one of the most widely used methods for the detection of biomarkers. However, rapid point-of-care (POC) detection of multiple cancer biomarkers by conventional ELISA is limited by long incubation time, large reagent volume, and costly instrumentation along with low sensitivity due to the nature of colorimetric methods.
Herein, we have developed a reusable and cost-effective paper-in-polymer-pond (PiPP) hybrid microfluidic microplate for ultrasensitive and high-throughput multiplexed detection of disease biomarkers within an hour without using specialized instruments. A piece of pre-patterned chromatography paper placed in the PMMA polymer pond facilitates rapid protein immobilization to avoid intricate surface modifications of polymer and can be changed with a fresh paper layer to reuse the device. Reagents can be simply delivered from the top PMMA layer to multiple microwells in the middle PMMA layer via flow-through microwells, thereby increasing the efficiency of washing and avoiding repeated manual pipetting or costly robots.
Quantitative colorimetric analysis was achieved by calculating the brightness of images scanned by an office scanner or a smartphone camera. Sandwich-type immunoassay was performed in the PiPP hybrid device after the optimization of multiple assay conditions. Limits of detection of 0.32 ng mL−1 for carcinoembryonic antigen (CEA) and 0.20 ng mL−1 for prostate-specific antigen (PSA) were obtained, which were about 10-fold better than those of commercial ELISA kits. We envisage that this simple but versatile hybrid device can have broad applications in various bioassays in resource-limited settings.
Breakdown of device cost to perform 8 samples with 6 replicates (i.e., 48 assays):
- Acrylic- $1/device
- Paper- $0.09/device
- Reagents including Antibody-$2.9/device
Total: $3.99/device; $0.08/assay
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