Exosome Dx is a non-invasive diagnostic test that uses microscopic cellular components to gather health insights. This tool assists in medical decision-making.
Understanding Exosome Dx
Exosome Dx analyzes exosomes, tiny vesicles released by cells into bodily fluids. These exosomes act as messengers, carrying proteins, lipids, and genetic material like RNA and DNA from their parent cells. By studying this cargo, the test provides insights into cellular activity and health.
The Science Behind Exosome Dx
The scientific basis of Exosome Dx involves collecting a biological sample, such as urine. Exosomes are isolated from the sample. Researchers then extract and analyze the genetic material, specifically exosomal RNA (exoRNA). The test measures expression levels of specific RNA biomarkers, such as PCA3, ERG, and SPDEF, which are elevated in certain diseases. A validated algorithm calculates a risk score based on these biomarker levels, providing insights into disease presence.
Primary Use in Prostate Cancer Diagnosis
The ExoDx test is primarily used for prostate cancer diagnosis in men with elevated prostate-specific antigen (PSA) levels (2-10 ng/mL). It helps determine the necessity of an initial or repeat prostate biopsy, an invasive procedure that can carry potential complications. By providing an individualized risk score for high-grade prostate cancer, the test aids physicians and patients in making informed decisions about whether to proceed with or defer a biopsy.
This urine test can help avoid unnecessary biopsies, with studies indicating it could prevent nearly 30% of biopsies. The test analyzes cancer-specific genomic biomarkers in urine, offering a risk assessment independent of PSA and other standard clinical features. It is particularly beneficial for men over 50 considering a prostate biopsy due to ambiguous PSA results. The test stratifies the risk of finding clinically significant prostate cancer, defined as Gleason Score 7 or higher, guiding further management.
What to Expect and Interpreting Results
The ExoDx Prostate test requires a urine sample collection. This non-invasive collection can be performed at home. A digital rectal exam (DRE) is not required before urine collection.
After analysis, the test provides a personalized risk score, generally ranging from 0 to 100. A score below a validated cut-off point, such as 15.6, is associated with a lower probability of high-grade prostate cancer on biopsy. Conversely, a score above this threshold suggests an increased likelihood of high-grade disease. It is important to discuss these results with a healthcare provider, who will interpret them in the context of other clinical information, such as age, family history, and prior PSA measurements, to determine the most appropriate next steps.