Biochip Array Analyzer Detects Colorectal Cancer-Related Polymorphisms

A diagnostic test can detect 28 polymorphisms associated with colorectal cancer (CRC) in a single stool sample.

The test, called RanplexCRC, does not require a hospital visit or dietary restrictions and is more sensitive than the currently used fecal occult blood (FOB) -screening test. It accurately profiles patients and reduces the number of patients for colonoscopy, saving time and resources and reducing patient discomfort.

Developed by Randox (Crumlin, UK), the test identifies selected mutations present in four genes: APC, KRAS, BRAF, and Tp53, along with wild-type control sequences. These mutations are represented on two biochips and are detected using Randox' biochip array analyzers.

The biochip array analyzers are immunoassay-testing platforms that work by combining panels of related tests on a single biochip. The chemiluminescent endpoint is detected by a charge-coupled device (CCD) camera and quantified by custom image-processing software. The company markets Evidence, a fully automated analyzer for high-throughput laboratories, and the Evidence Investigator, a semi-automated analyzer for low-throughput laboratories.

Most sporadic colorectal cancers follow a well-recognized progression from normal cells through adenoma (abnormal glandular growths) to cancer, driven by mutations in a small number of genes. CRC is the second largest cause of cancer mortality in the western world, but up to 90% are curable if detected early. Unfortunately, most patients present with advanced disease, reducing their long-term survival.

National screening programs are being introduced throughout Europe, to reduce CRC mortality, using the FOB test. This test suffers from poor sensitivity, as not all tumors bleed (false-negative test) and not all stool-blood are derived from tumors (false-positive test). Therefore, many patients (up to 50%) may be sent for colonoscopies unnecessarily. RanplexCRC provides the answer, filtering out false-positives.

Randox is a diagnostics company that develops, manufactures, and markets clinical diagnostic products worldwide. Core products include biochip array technology; clinical chemistry analyzers and reagents; quality controls; environmental diagnostics; and recombinant proteins and antibodies.

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