InterVenn Biosciences Announces New Publication On Colorectal Cancer Multivariable Classifier Model; Aims to Launch Colon Cancer LDT in 2023

InterVenn Biosciences, a company specializing in glycoproteomics, has released data on a new study published in Gastroenterology supporting the company’s serum glycoproteome test for colorectal cancer.

InterVenn’s GlycoVision™ platform combines advanced liquid chromatography-mass spectrometry (LC-MS) combined with artificial intelligence (AI). InterVenn’s LC-MS-based glycoproteomic uses a novel multivariable classifier model utilizing six key biomarkers for colorectal cancer and precancerous adenomas. The study utilized well documented blood samples from 279 cases (CRC and advanced adenomas) and 296 control samples. When applied to the training set, the test achieved an Area under the Receiver Operating Characteristic curve (AuROC) of 0.96, indicating high sensitivity and specificity in detecting both CRC and advanced adenoma. The classifier demonstrated a sensitivity of 90.9% for advanced adenoma without high-grade dysplasia, 85.7% for Advanced Adenoma with High Grade Dysplasia, 89.8% for all stages of CRC. This included 91.2% sensitivity for early-stage (stage 1 and 2) CRC and 89.4% for late-stage (stage 3 and 4) CRC, at a specificity of 89%. The company has stated that it plans to launch the test as a laboratory developed test (GlycoKnow™ Colon) in 2023 following its laboratory test validation study.

While this data is positive, it warrants caution. Multiple companies including Exact Sciences, Epigenomics, and Guardant Health have demonstrated much higher sensitivity and specificity when utilizing samples from well documented controls, and then seen test accuracy decline meaningfully in a real world clinical trial setting. Additionally, the company did not provide data on sensitivity and specificity based upon colon cancer stage – early stage accuracy (Stage 1/2) is most critical for early cancer detection tests and typically the most difficult to detect for a blood test given the reduced signature with early stage cancers. For example, Guardant Health’s Shield blood test for colorectal cancer demonstrated 90% sensitivity in early validation studies and was 83% in the ECLIPSE study with relatively low sensitivity in stage 1 cancers (55%).

Josh Stahl, InterVenn’s recently appointed CEO, expressed his enthusiasm, stating, “The resulting performance of the GlycoVision platform has the potential to aid patients, providers, and payers in the early diagnosis of colorectal cancer.”