The Association for Diagnostics & Laboratory Medicine’s Disruptive Technology Award recognizes innovative solutions to clinical problems in diagnostics access, speed, or performance. This year’s three finalists and three semifinalists address some of the most widespread problems facing today’s clinical labs—cancer, infectious disease, chronic illness, and more. Their incorporation of AI technology into existing and modified diagnostic procedures limits time-to-result delays, reduces the risk of mismatched treatments, and has the potential to improve patient outcomes.
Identifying the right antimicrobials in hours, not days
In the era of antimicrobial resistance, the rise of superbugs is a serious challenge for the medical system, with treatment-resistant infections affecting millions of people every year. Culturing a pathogen and testing for resistance is time-consuming. To combat this, Pattern Bioscience has developed an assay that bypasses the process completely by directly measuring individual bacterial cells’ responses to treatment. Aided by AI, this analysis can help care teams select the most suitable antimicrobial therapy for the infection. This rapid approach enables treatment in as little as four hours—an impressive advancement over the two to four days culture-based testing requires—and is aimed at reducing widespread prescription of unnecessary, inappropriate, and broad-spectrum antibiotics.
Pattern Bioscience has applied this technology to a pathogen identification and susceptibility testing panel for pneumonia, which received Breakthrough Device Designation from the U.S. Food and Drug Administration.
Detecting cancer with the touch of a pen
The MasSpec Pen™ by MS Pen Technologies, Inc., was developed to bridge the gap between complex lab mass spectrometry machines and point-of-care oncology treatment. Mass spectrometry can provide valuable information about a sample based on the molecules it contains, but the instruments are expensive and can be difficult to operate and maintain.
The MasSpec Pen™ is designed to provide the same information by using a drop of water to extract small molecules directly from patient tissue. The pen can then examine those molecules in real time to determine whether or not the composition indicates cancerous tissue. Application of this technology during tumor excision would allow surgeons to determine which tissues need to be removed. Not only is this beneficial for the surgeon, but it also removes the need for follow-up biopsies to ensure all cancerous tissue has been removed.
Although other intraoperative mass spectrometry technologies exist, the MasSpec Pen is uniquely nondestructive, meaning that the analyzed tissue can be preserved for additional diagnostic investigations or for research use.
Bedside diagnostics to avoid requisition delays
Waiting for a clinical lab to receive a specimen and perform diagnostic testing takes precious time that patients and healthcare providers may not have to spare. Whether the goal is to alleviate pressure on busy hospitals, increase field lab testing capacity, or deliver immediate treatment in an urgent case, bringing diagnostics to the bedside can help solve problems caused by long turnaround times. Vital Biosciences has developed a platform that requires only 100–600 μL of blood and 20 minutes to quantify over 50 of the most commonly requisitioned biomarkers in primary care. The instrument can run hematology, clinical chemistry, and immunoassays simultaneously, producing a readout that can be useful across a wide range of conditions from diabetes to post-acute event monitoring and lifestyle management. To further its aim of reducing the primary care test burden on busy laboratories, Vital Biosciences is currently expanding its platform to cover 100 percent of tests needed for 90 percent of patients.
Semifinalists target more efficient diagnostic tools for cardiovascular disease and cancer
Cardio Diagnostics’s Epi+Gen coronary heart disease tool combines genetics, epigenetics, and AI to assess patients’ risk of coronary heart disease. Requiring no fasting or radiation, this tool is the first to look beyond cholesterol levels and other proxy biomarkers to assess risk, increasing test sensitivity and sidestepping the potential pitfalls that may arise when relying on proxy markers or patient-reported information.
Hepatocellular carcinoma is one of the world’s most common cancers and the third leading cause of cancer deaths globally. To alleviate this burden, Eximius Dx developed a test for early detection and characterization of hepatocellular carcinoma. The Eximius Liver Cancer Test requires less than 1 mL of plasma or serum and takes only two hours to process. After successful Phase 2 testing, the FDA granted the test its Breakthrough Device Designation in 2022.
Blood was originally thought to be sterile; now, medical professionals know it is anything but. Research by Micronoma revealed that cancer isn’t sterile either, and that each type has a unique microbiome. Micronoma has now pioneered a new, minimally invasive liquid biopsy platform that examines circulating microbial nucleic acids to diagnose cancer. Although the eventual goal is to diagnose multiple cancers, the current focus is on lung cancer because the disease is so common—and so deadly if not diagnosed early.
A bright future for diagnostics
Clinical labs and diagnostic testing are the heart of the healthcare system. Earlier, faster, and more accurate diagnosis can ensure that patients receive the best possible treatment, improving outcomes and potentially saving lives. It is inspiring to see how far the diagnostics field has advanced since its early days—and to know that there are still pioneers driving the next steps in its evolution.