Novel Liquid Biopsy Platform Could Diagnose Disease State from Any Body Fluid

The diagnosis and management of chronic diseases is a significant challenge and burden to healthcare systems globally. Extracellular vesicles (EVs) carrying disease-specific biomarkers like nucleic acid and proteins are continuously released from cells and can be found in biological fluids including blood, urine, semen, and cerebrospinal fluid. The levels of disease-specific EVs are closely related to disease progression making EVs promising targets for minimally invasive diagnostic assays. Technology designed to accurately detect and measure EVs has the potential to greatly improve liquid biopsy diagnostics. Now, a novel liquid biopsy platform technology combines a highly sensitive EV detection platform with advanced machine learning (ML) algorithms to determine disease states from any fluid in the body.

The EV and machine learning platform ClarityDX from Nanostics (Alberta, Canada) is set to transform the diagnostic landscape and make easy-to-use, minimally invasive predictive tests a reality in the near future. ClarityDX uses micro-flow cytometry (µFCM) to quantify EV size, concentration, and marker abundance for millions of EVs in minutes. The platform then uses advanced machine learning to analyze the vast amount of data generated using µFCM to provide rapid and precise results that continuously improve with every test.

The ability to detect and measure EVs is transforming the diagnostic landscape in immunology, neurology, cardiology, and oncology. The ClarityDX platform technology is well-positioned for future pipeline products including tests for screening, early diagnosis, complementary diagnosis, monitoring, and management for many diseases and medically-related events. Nanostics continues to expand its product pipeline to include additional liquid biopsy diagnostic tests to improve patient care. The company’s lead product, ClarityDx Prostate is designed to improve the accuracy of detecting clinically significant prostate cancer in men that are at risk of the disease.

The ClarityDX Prostate test uses a proprietary machine-learning algorithm that combines data from two biological biomarkers and three clinical biomarkers to generate a risk score for clinically significant prostate cancer. The test is intended to be used as a reflex test for men with elevated levels of PSA, the current prostate cancer screening test, and is designed to help physicians and patients make a more informed decision to proceed with biopsy or not. Real-world data has shown that at a 94% sensitivity level for prostate cancer ClarityDX Prostate is 147% more specific than the PSA test for predicting clinically significant prostate cancer. Using ClarityDX Prostate as a reflex test vs. PSA test alone could have resulted in 37% fewer unnecessary biopsies.

“Our bodies use tiny messengers called extracellular vesicles to communicate throughout the body,” said Dr. John Lewis, CEO of Nanostics. “At Nanostics, our novel platform technology deciphers these messages to better diagnose disease. We are validating a new test that accurately diagnoses clinically significant prostate cancer from a few drops of blood.”

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