The ColoAlert test is designed as a complement to colonoscopies and is designed to help detect colorectal cancer early. Available in Europe, the at-home test is undergoing trials in the U.S.
By Chris Wolski
Colonoscopies are the gold standard when it comes to detecting colorectal cancer. However, about 20% of U.S. adults 45 and older have avoided this life-saving test1.
Mainz Biomed is hoping to change that statistic with its ColoAlert test. The easy-to-use, at-home test is already available in the EU, and has proven itself to be a reliable and accurate compliment to colonoscopies.
CLP recently caught up with Guido Baechler, PhD, at the ADLM (formerly AACC) conference in Anaheim, Calif., to discuss ColoAlert, its benefit as a complimentary test, and its status in the U.S. approval process. Baechler is the CEO and Director at Mainz Biomed, a developer of market-ready molecular genetic diagnostic solutions for life-threatening conditions. He has more than 30 years of leadership experience in the medical industry, including Roche.
Baechler’s answers have been edited for length and clarity.
CLP: ColoAlert test isn’t available on the U.S. market—yet—but can you give me an overview of how your test works and the advantages it has over similar tests?
Guido Baechler: ColoAlert is an at-home, early-detection diagnostic test for colorectal cancer. Patients receive a simple mail-in kit that includes instructions, a stool collector, and shipping instructions. Once finished, patients return the kit through regular mail to their local lab for testing, and results. Since cell material is continuously released into the stool in every person, ColoAlert can detect tumor DNA in simple stool samples. These results are based on real-time PCR multiplex detection of molecular-genetic biomarkers in stool samples, making it more sensitive than FIT results alone. This enables ColoAlert to detect colorectal cancer earlier and more accurately than conventional stool tests.
Mainz Biomed has recently embarked on two clinical studies aimed at assessing the performance of some new mRNA biomarkers in conjunction with the existing DNA biomarkers currently utilized in the ColoAlert test, as well as the FIT (fecal immunochemical test).
The interim analysis conducted in Europe has yielded remarkable results, showing a sensitivity of 94% and specificity of 97% for colorectal cancer (CRC) and 81% sensitivity for advanced adenomas (AA). These findings were derived from a sample size of 210 individuals, including patients with CRC, advanced adenomas (AA), non-AA conditions, and those with negative colonoscopies. Further details of the study will be unveiled at the at the 4th International Conference on Gastroenterology.
ColoAlert differs from U.S.-based providers of CRC screening tests through its decentralized business model, along with its simple collection device, simple shipping process, and the lower overall cost of the solution.
A test with an 81% sensitivity rate for advanced adenomas holds the potential to significantly reduce the incidence of CRC. This reduction, in turn, carries substantial implications for healthcare cost reduction and a significant improvement in the quality of life for patients by eliminating cancer.
Moreover, ColoAlert differs from U.S.-based providers of CRC screening tests through its decentralized business model, along with its simple collection device, simple shipping process, and the lower overall cost of the solution.
The test is CE marked; Mainz Biomed is currently undergoing a pivotal FDA clinical study for U.S. regulatory approval.
CLP: Colonoscopy remains the gold standard for diagnosing colorectal cancer—is your test meant to replace it or is it an adjunct to it? If it’s the latter—in what circumstances would this be needed?
Baechler: ColoAlert does not replace a colonoscopy. Colonoscopies are done every 10 years or so for low-risk patients. It’s imperative that individuals perform screening tests in-between to minimize the risk of getting CRC. ColoAlert is a perfect solution for patients to get tested in-between the long colonoscopy cycles. And with 45 as the recommended screening age, ColoAlert is an intuitive and scalable implementation.
FIT tests, especially when combined with technologies like ColoAlert, are unlikely to replace colonoscopies entirely. Instead, they will complement these invasive procedures. A positive ColoAlert or FIT result may prompt healthcare providers to recommend further diagnostic investigations, such as colonoscopy, for a definitive diagnosis and tailored treatment planning. If a ColoAlert result comes back positive, we recommend that the patient undergoes a colonoscopy for further confirmation and treatment.
CLP: Would this be an over-the-counter test?
Baechler: The test is currently available through a physician network in Germany and selected other European countries as well as through the ColoAlert web shop in Germany.
CLP: Where are you now with the test? Will it be in the U.S. market soon?
Baechler: We have actively sought opportunities to enhance the performance of our existing ColoAlert colorectal cancer screening test. Our primary objective was to elevate both the sensitivity and specificity for early cancer detection, while concurrently elevating the sensitivity for advanced adenomas and precancerous lesions. The more effectively we can identify precancerous lesions, the greater the potential impact on reducing the incidence and mortality of colorectal cancer.
ColoAlert is CE-IVD marked and currently available in selected European countries, including Germany, Italy, Poland, and the United Kingdom, among others. We plan to start the commercialization in the U.S. once we have earned FDA approval. We currently predict rollout in the U.S. market to take place in 2026.
CLP: What do you think the future of FIT tests will be broadly in healthcare? Will they become more common, and will this cause more people to rely on these types of at-home, non-invasive tests over standard colonoscopy?
Baechler: The future of FIT in health care holds significant promise, and innovations like ColoAlert, which combines real-time polymerase chain reaction (PCR)-based multiplex detection of molecular-genetic biomarkers with the FIT test, are expected to play a pivotal role in reshaping CRC screening. ColoAlert’s integration of molecular-genetic biomarkers into the FIT test represents a substantial leap in CRC screening technology. By augmenting the FIT test with multiplex DNA markers, this approach significantly enhances the test’s sensitivity. This improvement extends to early-stage CRC detection, making it a highly beneficial tool in the quest for early intervention and improved patient outcomes.
FIT tests have gained popularity due to their non-invasive nature and convenience, and innovations like ColoAlert are likely to accelerate this trend. As healthcare systems and individuals increasingly prioritize preventive care and early cancer detection, with personalized options on offer as well, ColoAlert and similar advances are poised to become more common and widely accessible, reaching high-risk individuals in time for effective treatment. This also means fewer screenings wasted where they are not appropriate.
These tests will continue to evolve, working in tandem with other diagnostic tools and technologies to ensure comprehensive and accurate early detection of colorectal cancer, ultimately improving patient outcomes and reducing the burden of this disease.
CLP: What role does the lab play in the continuum of testing/care with the ColoAlert test?
Baechler: The labs play an integral role in our business. We transfer our technology to external lab partners allowing them to offer ColoAlert through their networks to health care professionals and patients. As it stands at the moment, Mainz Biomed is the only lab that plans to offer such decentralized tests in the U.S. All other screening companies (e.g., Exact, Guardant, Geneoscopy) are offering or will offer their test though a centralized CLIA lab.
Chris Wolski is chief editor of CLP
Reference
- “Adults Who Have Never Been Screened for Colorectal Cancer, Behavioral Risk Factor Surveillance System, 2012 and 2020.” Lisa C. Richardson, MD, MPH; Jessica B. King, MPH; Cheryll C. Thomas, MSPH; Thomas B. Richards, MD; Nicole F. Dowling, PhD; Sallyann Coleman King, MD, MSc. Centers for Disease Control and Prevention (CDC). April 21, 2022. https://www.cdc.gov/pcd/issues/2022/22_0001.htm
