Many traditional clinical laboratory assays and methodologies miss the mark when it comes to meeting patient care needs. Longstanding tumor markers, such as CA125 and HE4, fail to reliably detect ovarian cancer until later stages, when treatment options are limited and prognosis is poor. Our reliance on blood-based testing presents a barrier to access for some patients. As a field, we can and must do more to bridge the diagnostic gap.
Monday’s scientific session, “Emerging Nano-Engineering Technologies for the Management of Chronic Diseases and Cancers,” featured up-and-coming testing modalities poised to enter the clinical diagnostics space.
Session moderator, Lakshmi Ramanathan, PhD, was motivated to assemble this interdisciplinary session because of the urgent need for new diagnostic technologies. Despite technological evolution and advancement in the research environment, translation to the clinical laboratory is still uncommon. A significant bottleneck is access to well-characterized clinical samples and accompanying clinical information, two areas where laboratorians are well-equipped to contribute.
According to Ramanathan, our ready access to clinical samples from patients with myriad disease states is a “treasure trove” that is too often overlooked.
To start the session, Mijin Kim, PhD, described the use of perception-based sensing technology in the form of carbon nanotube biosensors. Akin to our olfactory system, perception-based sensing is not designed to detect specific targets, but to detect patterns of multiple analytes to generate “whole disease fingerprints.” Nanosensors generate signal via changes in their physicochemical properties when targets bind to the surface.
Interestingly, the composition of the collection of bound targets, or “biomolecular corona,” is often unknown. However, it can be directly profiled by mass spectrometry and other techniques to identify the molecular interactions responsible for the disease-specific fingerprints. Kim postulated that this targeted approach could unveil biomarkers of disease or potential therapeutic targets. Carbon nanotube biosensing has been most thoroughly studied in the context of high-grade serous ovarian carcinoma, where it outperforms traditional markers CA125 and HE4 in terms of both diagnostic sensitivity and specificity.
However, it can also be used to help predict other important conditions, such as pancreatic cancer and pregnancy loss. Kim emphasized the importance of collaborating with clinical colleagues to hone nanosensor technology and determine if it is fit for clinical purpose.
Chamindie Punyadeera, PhD, then showcased cutting-edge, saliva-based technologies with potential clinical utility for detecting chronic diseases and cancers. She shared two examples of saliva-based diagnostics she shepherded from concept to commercialization, including a molecular signature for oral and throat cancer and a companion diagnostic for heart failure.
As a testing matrix, saliva offers many advantages, such as ease of sampling in challenging clinical environments, and its ability to be used to probe systemic disease. For example, Punyadeera highlighted a multiplexed PCR-based method for detecting DNA from a “swish and gargle” collection. This technique allowed for the discovery of an occult HPV-driven oropharyngeal cancer in a healthy person despite negative imaging studies, highlighting the technology’s role in expediting initial diagnosis or recurrence detection. Given that many of these novel diagnostics are already in clinical trials, Punyadeera predicted they will enter the clinical arena within five years.
In the rapidly evolving field of laboratory medicine, collaborations between clinical and research colleagues are crucial. Session attendees came away with a greater awareness of the significant limitations of many traditional tests, the diagnostic gaps that these shortcomings cause, and the emerging technologies making their way into the clinical laboratory to improve patient care.