RanplexCRC is a diagnostic test that can detect 28 polymorphisms associated with colorectal cancer in a single stool sample. It does not require a hospital visit or dietary restrictions, while having greater sensitivity than the currently used Faecal Occult Blood (FOB) screening test. RanplexCRC may more accurately profile patients and reduce the number of patients for colonoscopy, saving time and resources and reducing patient discomfort.
Most sporadic colorectal cancers follow a well recognised progression from normal cells through adenoma (abnormal glandular growths) to cancer, driven by mutations in a small number of genes. RanplexCRC can simultaneously detect 28 mutations from four key genes in cancer or pre-cancer cells shed into the bowel. Selected mutations present in APC, KRAS, BRAF and Tp53, along with wild-type control sequences, are represented on 2 biochips detected using Randox's Biochip Array Analysers.
The Randox family of Biochip Array analysers are immunoassay testing platforms that work by combining panels of related tests on a single biochip. The chemiluminescent endpoint is detected by a CCD-camera and quantified by a custom image-processing software. Evidence, a fully automated analyser for high-throughput laboratories, and the Evidence Investigator, a semi-automated analyser for low-throughput laboratories and research purposes, are both available from Randox.
Bowel (colorectal) cancer is the second largest cause of cancer mortality in the western world, but up to 90% curable if detected early. Unfortunately, most patients present with advanced disease, reducing their long term survival. National Screening programmes are being introduced throughout Europe, to reduce CRC mortality, using the FOB test. This cheap and non-invasive test detects blood in stool samples, which may be an indication of a tumour. Patients with a positive FOB test are then referred for colonoscopy. The FOB test, however, suffers from poor sensitivity, as not all tumours bleed (false negative test) and not all stool-blood is derived from tumours (false positive test). Many patients (up to 50%) may therefore be sent for colonoscopies unnecessarily. Colonoscopies are invasive, involve dietary restrictions and require the presence of a surgeon, so an intermediate test would benefit both the patient and the healthcare system. RanplexCRC provides the answer, filtering out false positives.
Randox is an international diagnostics company, headquartered in the UK. Randox develop, manufacture and market clinical diagnostic products worldwide. Core products are: Biochip Array Technology; clinical chemistry analysers and reagents; quality controls and EQA; environmental diagnostics; recombinant proteins and antibodies.