Offering lower costs and quicker returns than much of the traditional lab equipment in use today, lab-on-a-chip devices are again in a position to revolutionize pathology and medical laboratory work
For nearly 20 years, researchers have heralded microfluidic devices, paper-based diagnostics, and other lab-on-a-chip (LOC) technologies, as ways for medical laboratory scientists, pathologists, and other medical diagnostic professionals to reduce the time and costs of clinical laboratory services. With the promise of obtaining results in just minutes without the need for extensive training, these point-of-care tests and devices create big buzz with each new design.
That leaves one major question for clinical laboratory professionals and chip developers alike—when is the revolution?
The Growth of Lab-on-a-Chip Devices
Many of today’s LOC offerings are rooted in the microfluidics research of the 1980s.
As outlined on the ELVEFLOW website, the emergence of adapting these technologies for healthcare and testing purposes—as well as performing complex, multi-step procedures—started in the 1990s, as groups worked to miniaturize:
• polymerase chain reaction (PCR) tests;
• cell lysis; and
ELVEFLOW is a registered brand of microfluidic flow control technologies developed by ELVESYS. Located in Paris, France, ELVESYS is a self-funded microfluidic instrumentation company.
The US government took interest in the technology for military use. With that interest came funding that has pushed various LOC technologies to the point where we are today.
What Stalls Adoption of Lab-on-a-Chip?
With each new release, experts claimed lab-on-a-chip devices were poised to change the face of pathology and medical laboratory work. However, while some devices have seen success, most are still relegated to the news stories and journals instead of the physician’s office or medical laboratory.
A paper published in ScienceDirect, “Lab-on-a-Chip or Chip-in-a-Lab: Challenges of Commercialization Lost in Translation,” highlights the largest obstacles the authors believe face the widespread use of LOC devices. Co-author Mazher-Iqbal Mohammed, research fellow at Deakin University, Geelong, Victoria, Australia, noted, “Many academic researchers are found guilty of leaving the challenge of technology transfer into a commercially viable product as an afterthought over being a critical consideration of the overall engineering process chain.”
Another major issue cited in the paper is the dependence of many lab-on-a-chip devices on ancillary equipment. While the chip itself might offer an affordable and easily-accessed alternative to traditional laboratory tests, by the time the costs of pumps, power supplies, signal acquisition equipment, and other needs are included, LOC devices are no longer the pocket- and budget-friendly devices seen in headlines.
Lastly, the paper’s authors noted that a lack of standardization is preventing the mass production, development, and implementation of most LOC devices. They state, “[Whilst] the great diversity in material and fabrication selection allows for greater flexibility and innovation in terms of research endeavor, it greatly limits a standard material and technique reaching the mainstream for lab-on-a-chip manufacturing, and is likely a contributing factor to the slow commercial uptake of the technology.”
The Future of LOC Devices
Krisna Bhargava, PhD, of University of Southern California Viterbi School of Engineering, is among several researchers tackling the standardization issues mentioned above with a novel modular LOC concept. Outlined in “Modular Components Make Building 3D ‘Labs-on-a-Chip’ a Snap,” the team’s approach uses 3D printing to create elaborate LOC designs for manufacturing LOC devices that can be assembled by hand. The parts are called modular fluidic and instrumentation components (MFICs) and they snap together, creating a 3D shape capable of performing a wide range of microfluidic processes.
Aydogan Ozcan, PhD, of University of California Los Angeles, is addressing the need for ancillary equipment by integrating imaging capabilities into the LOC format. Using a light-emitting diode and sensor arrays, his team’s devices create 3D images of specimens. In an article published in Engineering 360, Ozcan noted, “In research labs, we are seeing all kinds of beautifully engineered tests performed on microfluidic devices as small as a credit card. But unless you also include imaging capability on these devices, you don’t really have a complete LOC design.”
In the past six years, Dark Daily reported frequently on the rise of these new devices:
• In 2010, “Pathologists Watch as New Lab-on-a-Chip Technology Is Developed for Testing Patients in Doctor’s Offices” brought the promise that testing could take place in the office without the costs or wait times of clinical laboratory testing.
• In 2011, “Rapid HIV Test Could Revolutionize Clinical Laboratory Testing Performed in Developing Nations” highlighted the mChip device for detecting HIV and syphilis in remote regions.
• In 2013, “Implantable Medical Laboratory-on-a-Chip Continuously Monitors Key Chemicals in Chemotherapy and High-Risk Patients” talked of implanting lab-on-a-chip monitors making it possible to monitor biomarkers and assess treatment in real time.
• In 2014, “Nanotechnology-Based Medical Laboratory Test Chip Developed at Stanford University Detects Type-1 Diabetes in Minutes and Can Be Used in Doctors’ Offices” offered a fast and affordable option for diabetes screening to help combat the rise in childhood diabetes and obesity.
• In 2015, “Sleek ‘Lab in a Needle’ Is an All-in-One Device That Detects Liver Toxicity in Minutes during a Study, Showing Potential to Supplant Some Medical Laboratory Tests” showed a complex liver toxicity screening that automated the majority of the screening process while eliminating the need for wet laboratory work and expert training.
Despite obstacles and continued delays to the LOC revolution, data from BCC Research (BCC) indicates that the future of LOC devices still holds the potential to significantly change how pathology and medical laboratories function.
In a report covering DNA microarrays, protein microarrays, tissue and glycomics microarrays, and LOC devices, BCC predicts a 31.6% compound annual growth rate in the global market for biochip products. If standardization continues to improve, and LOC creators emphasize production-friendly designs, the predicted “revolution” might be on the horizon.
However, given the 20 years that have passed with advocates and developers of point-of-care technologies regularly promising a revolution in clinical diagnostics, pathologists and clinical laboratory managers can be forgiven for retaining some healthy skepticism about the near future. In the meantime, the medical laboratory profession is benefiting from the miniaturization of many aspects of lab testing that were originally developed by researchers working on lab-on-a-chip technologies. Labs can buy all sorts of analyzers that have a smaller footprint and perform more sensitive assays with smaller sample amounts. From that perspective, the clinical laboratory industry is benefiting from all that research conducted over the past 20 years.