Blood-Based Molecular Cancer Test Delivers Unsurpassed Accuracy and Specificity Levels

The absence of an accurate blood biomarker in neuroendocrine tumor (NET) disease has hampered its effective management. The progress made in genomic medicine and the emergence of molecular biomarkers have paved the way for the adoption of liquid biopsy as a solution to allow for real-time management. Now, a blood-based neuroendocrine cancer diagnostic test can be used to help diagnose, recommend treatment, and then monitor progress for NET or neuroendocrine neoplasia (NEN) patients in real time.

The NETest from Wren Laboratories (Branford, CT, USA) assesses mRNA gene expression analysis to diagnose NETs. By focusing on mRNA, Wren achieves real-time evaluation of the disease state in NET or NEN patients through the interpretation of molecular signals released by cells related to neuroendocrine cancer activity found in a blood sample. The rapid and non-invasive liquid biopsy test enables results to be shared within 48 hours of receiving a blood sample. Upon arrival of the sample at Wren's CAP and CLIA-certified laboratory, a quantitative polymerase chain reaction (qPCR) technique is employed to quantify the expression levels of 51 genes linked to neuroendocrine cancer. Subsequently, Wren employs multianalyte algorithmic analyses (MAAA) to calculate the likelihood of a patient having a NET or NEN. The resultant probability or risk score is then made available.

The NETest outperforms any other available testing method in terms of sensitivity, specificity, and accuracy. It surpasses other NET diagnostics in robustness, boasting a remarkable 98% sensitivity that translates to minimal false negative results. It also exhibits an 86% accuracy in determining disease status (distinguishing between stable and progressive disease), a level of precision unmatched by other diagnostic methods. The results from the NETest offer insights into the tumor's state, the presence of residual disease, and the potential for recurrence. The NETest demonstrates an impressive 99% accuracy in diagnosing post-treatment recurrences. Due to its exceptional accuracy in recurrence determination, the test reduces the need for imaging in nearly half of the patients, thereby mitigating radiation exposure.

Furthermore, it assesses the tumor's response to treatment. This comprehensive information aids oncologists and patients in enhancing treatment management and monitoring, facilitating swift detection of disease recurrence. Additionally, Wren offers a companion prognostic tool to the NETest, referred to as PPQ, designed to evaluate the efficacy of peptide receptor radionuclide therapy (PRRT). The PPQ exhibits 94% accuracy in measuring the response to PRRT, far surpassing current predictive diagnostic methods such as somatostatin receptor expression and morphological imaging or chromogranin A (CgA) measurement.

“Our NETest uses the cellular messaging system of the human body - mRNA – to detect tumor activity in the bloodstream, often before a tumor can be seen,” said Mark Kidd, Ph.D., laboratory and scientific director. “As the NETest panel includes 51 genes, we employ machine learning, also called AI, to analyze this incredibly dense molecular information about a patient’s tumor status.”

“NETest puts patients in the best position possible to understand their disease and, specifically, how they are responding to treatment,” added Dan Buck, general manager. “This blood-based assay provides invaluable information delivered in a simple manner that helps oncologists and patients better understand where they are in their cancer journey.”

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Wren Laboratories