NEW YORK – Interim results from Mainz Biomed's ColoFuture study released last month may further validate the use case for the firm's next-generation colorectal cancer screening assay as the company prepares to initiate additional studies.
The existing ColoAlert test, which is available across Europe and in some Middle Eastern countries, combines fecal immunochemistry analysis with PCR to detect DNA tumor markers that may indicate colorectal cancer in stool samples collected at home. It has been commercially available for over a year, and the company has partnered with multiple regional laboratories in a variety of countries, including Germany, Spain, the United Arab Emirates, and Israel, to commercialize and distribute ColoAlert to primary care physicians. The German company also sells the test online and to corporations as part of employee health programs, Mainz CEO Guido Baechler said.
The multicenter ColoFuture study was intended to determine the potential of integrating a portfolio of mRNA biomarkers into the firm's next-generation colorectal cancer screening test and involved 220 patients from Germany and Norway. Participants had either been referred for a colonoscopy or had a diagnosis of colorectal adenocarcinoma with no previous treatment. The samples were tested with RT-qPCR to detect two DNA markers and six mRNA markers, as well as one housekeeping gene for standardization.
They also underwent analysis with an algorithm developed using artificial intelligence and designed by Liquid Biosciences to determine which of the mRNA biomarkers will work best for the next-generation test. The firm is working with Liquid Biosciences to further refine the algorithm and make it more robust, which will significantly boost the performance of the test, Baechler said.
Results from the ColoFuture study, which will be presented at the 4th International Conference on Gastroenterology, demonstrated that the sensitivity of the test for detecting colorectal cancer was 94 percent, while precursor lesions including advanced adenomas were detected with 80 percent sensitivity. Specificity for colorectal cancer was nearly 97 percent and specificity for advanced adenomas was 95 percent, and sensitivity for high-grade dysplasia was 75 percent.
Baechler said that the study hit its endpoints, although he added that it is a relatively small study. The firm is "bullish" on its colorectal cancer sensitivity and expects it to stay consistent as the company moves to larger studies, but Baechler noted that the advanced adenoma sensitivity may decrease because of differences in the patient population and how advanced patients' cancers are.
Improved advanced adenoma sensitivity was a key point of focus for Mainz with its next-generation test, since that has been difficult to achieve for other competitors in the market, Baechler said. At the start of 2021, the company began evaluating other biomarkers it could add to ColoAlert to improve that sensitivity, finding biomarkers from Sherbrooke University that showed "extremely strong" sensitivity for advanced adenomas and licensing them, Baechler said.
In addition to the new biomarkers added to the original ColoAlert test, Baechler said that the firm also developed a proprietary buffer solution to ensure a sample's stability when exposed to different temperatures. Because of the stability, the samples will be able to be shipped inexpensively via regular US mail. The buffer solution will stay the same when the next-generation test is commercialized, he noted.
Although the company does not disclose exact volumes of ColoAlert, it has seen growth over the past year. The firm announced last week that its Q3 2023 revenues were up 88 percent year over year to $181,669.
Chun Tang, a doctor in the UK and cofounder of medical technology distributor Biox Medical, has incorporated ColoAlert into his firm's health screen packages and has made the test available for clinics. In his view, "for patients who present to private clinics with symptoms that require diagnostics … ColoAlert is an ideal option as an initial test for their relevant symptoms."
Although he said he has faced logistics challenges in getting samples to the lab quickly, the rapid detection "has given clinicians comprehensive information to aid them in their diagnosis." It has also given gastroenterologists "extra insight on the severity of the case compared to the usual FIT test alone," he said.
While ColoAlert is available in certain countries as is, Baechler said that the company doesn't plan to commercialize the existing test in the US. Instead, it will conduct a premarket approval study of the next-generation test to prepare for regulatory submission to the US Food and Drug Administration.
The US arm of its ColoFuture study, called EAArly Detect, will likely read out before the end of the year, Baechler said. Meantime, the ReconAAsense trial, its premarket approval study, is expected to begin enrolling patients in mid-2024, ultimately recruiting 15,000 patients across the US.
Right now, Mainz does its own in-house manufacturing of the test and sample collection kit with some outsourcing, but once it moves to commercialize ColoAlert in the US it will likely work with manufacturing partners and distributors to make and distribute the reagents and sample collection kit, Baechler said.
In the US, Exact Sciences is the main player in the colorectal cancer screening market with its Cologuard assay, which has been on the market for several years following FDA clearance — but Baechler said he isn't worried about breaking into the market. In contrast to Exact, which tests samples at its own CLIA laboratories, Mainz plans to partner with large existing laboratories, such as Laboratory Corporation of America and Quest Diagnostics, to leverage their existing networks and sales organizations to reach primary care physicians. While Baechler declined to specify which laboratories the company has spoken to about this plan, he noted that it has received "very strong feedback" about it.
"It would be a pretty seamless integration of our test into a relatively large network in the United States," he said. The company has no plans to build a CLIA-certified laboratory in the US because it would "have no chance" against other competitors, he added.
"There's space for more than one company in the US," he said. "There's a lot of groups, a lot of people, who do not have access yet to colorectal screening tests."
Other companies looking to compete in the space include Geneoscopy, which released data on its stool-based ColoSense test earlier this month. In the 8,920-person trial, the test had sensitivity of 94 percent for detecting colorectal cancer and 46 percent for advanced adenomas while specificity was 88 percent. Exact Sciences filed a patent infringement suit against Geneoscopy last week in the US District Court for the District of Delaware claiming that Geneoscopy's test uses methods for processing stool samples covered by an Exact patent.
The clinical data published nearly a decade ago for Exact's Cologuard assay showed 92 percent sensitivity for colorectal cancer and 42 percent sensitivity for advanced precancers in its prospective trial with specificity of 90 percent. However, the firm is working on a next-generation assay expected to launch in 2025 that, in a study with more than 20,000 patients, has shown cancer sensitivity of 94 percent, advanced adenoma sensitivity of 43 percent, and specificity of 93 percent.
Mainz expects its next-generation test to be available in both the US and Europe by mid-2026, Baechler said.
Beyond colorectal cancer, Mainz is also working on a test for pancreatic cancer and has plans to develop other cancer tests that can be used with stool samples, Baechler said. Earlier this year, the company announced a partnership with Australian microbiome company Microba Life Sciences to discover novel microbiome markers for pancreatic cancer screening.
