Mainz Biomed has been manufacturing ColoAlert which is a non-invasive mt-stool DNA screening test designed for early detection of cancer. OSP wanted to know more about this potentially life-changing and life-saving test and sat down with Mainz to find out more.
OSP: What is ColoAlert and how does it function in the detection of colorectal cancer?
By analyzing stool samples for tumor-DNA and occult blood the test enhances the likelihood of identifying the disease in its early, more treatable stages. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, it can detect more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018, Franck et al. 2024).
OSP: What distinguishes ColoAlert from traditional methods of colorectal cancer screening?
It stands out from traditional colorectal cancer screening methods primarily through its innovative use of tumor-DNA analysis, offering a high sensitivity and specificity in detecting the disease. Unlike conventional screenings that often require invasive procedures such as colonoscopies, this test provides a more convenient and patient-friendly approach. It allows individuals to collect stool samples at home, ensuring an easier and more accessible screening process. This ease of use not only facilitates a more comfortable experience for patients but also encourages regular screening, enhancing early detection rates. The precision of tumor-DNA analysis, combined with the non-invasive nature of the test, positions ColoAlert as a cutting-edge option for those seeking efficient and reliable colorectal cancer screening.
OSP: Can you explain the technology or methodology behind the test’s effectiveness in identifying colorectal cancer?
It employs a sophisticated methodology to effectively identify colorectal cancer. First human DNA is extracted from a stool sample, leveraging the principle that colorectal tumors shed cells into the stool. Utilizing PCR technology, the test amplifies this extracted DNA to facilitate a detailed analysis. This amplified DNA is then scrutinized using PCR technology to detect specific mutations in the KRAS and BRAF genes, which are commonly associated with colorectal cancer. In addition to these genetic markers, the test incorporates a conventional analysis for occult (hidden) blood in the stool. This multi-faceted approach combines the sensitivity of molecular diagnostics with traditional testing methods, enhancing the ability to accurately identify colorectal cancer at early stages.
OSP: How accurate is ColoAlert in detecting colorectal cancer, and has it undergone clinical validation?
The detection rate of the test was determined by an independent clinical study in Germany. In the study, 566 patients were examined using an occult blood test, M2-PK, ColoAlert (Combined DNA Stool Assay) and a colonoscopy. The colonoscopy was used as a reference method. The test showed the most accurate predictive values among the non-invasive screening methods with a sensitivity of 85 % for colorectal cancer and a specificity of 92 % (Dollinger et al., 2018). Further studies are being conducted to validate the accuracy.
OSP: Is the test readily available for use by healthcare professionals and patients, and if so, how accessible is it?
It is widely available and accessible for both healthcare professionals and patients in several countries, including Germany, Poland, Spain, Romania, England, and Israel. It is designed for both professional use in medical settings and lay use by individuals at home, which enhances its accessibility and convenience. The availability and means of access to it can vary by country. For instance, in Germany, patients can obtain the test through multiple channels: directly from physicians, via a web shop, at pharmacies, or through company health programs.
OSP: Are there any specific demographics or risk groups for whom ColoAlert is particularly recommended?
The test is recommended for asymptomatic individuals starting at the age of 45, as this age group typically begins to experience a higher risk of developing colorectal cancer. For those with additional risk factors—such as a family history of the disease, obesity or diabetes mellitus — it can be used earlier upon recommendation and consultation with a healthcare provider.
OSP: What are the potential benefits of using this test in colorectal cancer screening programs, both for individuals and healthcare systems?
It offers significant benefits both for individuals and healthcare systems. For individuals, the primary advantage lies in the potential for early detection of colorectal cancer, which is crucial for improving survival rates and reducing the overall treatment burden. Early detection often means that colorectal cancer can be treated more effectively and less invasively, typically resulting in better patient outcomes and quality of life.
For healthcare systems, earlier detection can lead to substantial cost savings. Treating colorectal cancer in its initial stage is generally less expensive and less complex than treating more advanced stages of the disease. Research suggests that detecting 50% of European patients at stage I could not only save approximately 130,000 lives annually but also reduce healthcare expenditures by over 3 billion euros each year.
Additionally, it enhances screening accessibility and ease of use while maintaining precision, making it an attractive option for widespread implementation in screening programs.
OSP: How does ColoAlert compare to other emerging technologies or methods in colorectal cancer screening?
There are two competing emerging technology for colorectal cancer detection currently: blood-based tests and stool DNA tests. Recent studies have highlighted the limitations of blood-based tests, especially their lower performance in detecting precancerous lesions such as advanced adenomas. This limitation is critical as identifying and treating these lesions early can prevent the progression to cancer.
In contrast, ColoAlert, which utilizes stool DNA analysis, has demonstrated higher efficacy in detecting both cancerous and precancerous conditions. For instance, in a recent case study, it successfully identified a high-risk polyp in a patient who had previously received a negative result from a colonoscopy. This detection capability underscores the advantage of stool-DNA testing in providing a comprehensive screening option that can capture more cases earlier, thereby potentially improving outcomes and reducing the overall burden of colorectal cancer (Frank et al., 2024).
OSP: What ongoing research or developments are underway to further improve the test’s performance or accessibility?
Ongoing research and developments are actively being pursued to enhance both the performance and accessibility of the test. Efforts include extensive clinical studies aimed at deepening the understanding and validation of the test’s data, which could lead to refinements in detecting colorectal cancer more accurately and at earlier stages. Additionally, product development initiatives are underway to improve lab performance, particularly focusing on optimizing DNA extraction processes from stool samples, which is crucial for ensuring the test’s reliability and sensitivity.
Furthermore, improvements are being made to the patient experience, especially in the design of the stool sample collection kit. These enhancements aim to simplify the collection process, making it more user-friendly and less cumbersome for individuals. By addressing these aspects, the test is set to become even more effective and accessible, helping to streamline colorectal cancer screening for widespread use.
OSP: Are there any limitations or considerations that individuals should be aware of when using this test for colorectal cancer screening?
It is not recommended for individuals with conditions like irritable bowel syndrome, chronic inflammatory bowel diseases (including ulcerative colitis and Crohn’s disease), familial adenomatous polyposis (FAP), or hereditary non-polyposis carcinoma (HNPCC). Additionally, as with all screening methods, ColoAlert can generate false positives and negatives. Therefore, it is essential for individuals to consult with a physician to interpret results accurately and determine the appropriate follow-up actions. This ensures that the test is used effectively within its intended scope.
