ColoPlex Biomarker Data Published in
Journal of Clinical Oncology
Novel blood-based biomarker candidates in screening for colorectal cancer.
Jason Lee Liggett, Mathias M Petersen, Jakob Kleif, Morten Rasmussen, Lars Nannestad Jørgensen, Jakob Benedict Seidelin, Mogens R. Madsen, Jesper Vilandt, Kåre Andersson Gotschalck, Lars M. Andersen, Ali Khalid, Berit Andersen, Ib Jarle Christensen, Herbert A. Fritsche, Eric S. Mayer, Christina Therkildsen
Background: Colorectal cancer (CRC) is the third most common cancer worldwide motivating national screening strategies utilizing fecal immunochemical tests (FIT). Blood-based biomarkers could be an alternative method to increase compliance in population-based screening programs for early detection of CRC. We aimed to identify new blood-based biomarkers that could be potential candidates for use in colorectal cancer screening. Methods: In a nested cohort study of 1967 FIT positive participants of the Danish CRC screening program serum levels of GDF-15, hepsin, IL-8, keratin1-10, L1CAM, MIA, monocyte MCP-1, NSE and OPG were measured using the Luminex xMAP immunoassay platform. Main outcomes were CRC vs non-CRC and CRC, high-risk adenomas (HRA) or medium-risk adenomas (MRA) vs low-risk adenomas (LRA) or clean colorectum. Odds ratios for associations between biomarker expressions and outcomes were calculated using logistic regression models and visualized by area under the receiver operating characteristic (ROC) curve (AUC). Analyses were made on the Luminex biomarkers alone and with addition of clinical and demographic information. Results: FIT-induced colonoscopies detected 240 CRCs and 625 HRA or MRA. Multivariate analyses using all biomarkers and age found hepsin, IL-8 and OPG significantly (p<0.001) associated in relation to the main outcome (CRC vs non-CRC) with odds ratios of 0.74 [0.59-0.92], 2.59 [2.12-3.15] and 0.90 [0.82-0.99], respectively. The full model using all biomarkers and age presented an AUC of 0.73 [0.70-0.77]. Conclusions: Changed serum levels of nine novel biomarkers seem to be potential predictors for early detection of CRC, especially hepsin, IL-8 and OPG.
NAVIGATING REGULATORY APPROVAL WITH A CRO IN IVD DEVELOPMENT
The development and commercialization of medical devices, including diagnostics, require a significant investment of time, resources, and expertise. To navigate the complex regulatory approval process and bring a device to market, many medical device companies partner with contract research organizations (CROs). In this article, we will explore the role of CROs in the diagnostics industry, the benefits of working with a CRO, and the different services that CROs provide to help companies bring their diagnostic devices to market.
Want to chat with us during AACC? We want to see you in Chicago. Use the link below to schedule time with EDP during the show. We'd love to schedule some time to meet you at AACC next week. In attendance will be Eric Mayer, CEO, Jon Dancy our Business Development...
Luminex Partner Spotlight
Early detection makes a real difference in outcomes for cancer patients. But for cases of colorectal cancer, detecting tumors in the earliest stages has been virtually impossible. The team at EDP Biotech is committed to changing that by developing a simple, accurate, blood-based diagnostic test for biomarkers of colorectal cancer.
By Abby Kousouris Published: Aug. 17, 2021 at 7:25 PM EDT KNOXVILLE, Tenn. (WVLT) - A local Knoxville company says they’re seeing more demand for COVID-19 testing. EDP Biotech Corporation has different options available for people who want to find out if they have...
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