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Mainz Biomed Stock Spikes on Positive Data for mRNA-Enhanced Colorectal Cancer Screening Assay

NEW YORK – Shares of German molecular diagnostics firm Mainz Biomed jumped nearly 16 percent in Wednesday trading on the Nasdaq after the company released unpublished positive top-line results from a clinical trial demonstrating high sensitivity for its flagship ColoAlert assay with new mRNA biomarkers in detecting colorectal cancer (CRC) and advanced adenomas.

ColoAlert uses PCR to analyze tumor DNA found in stool samples collected in a patient's home for the early detection of CRC. The company, which is headquartered in Mainz and has US offices in Berkeley, California, has been developing the assay for several years and offers it commercially in the EU. Last year it acquired a portfolio of mRNA biomarkers from the Université de Sherbrooke in Canada to potentially enhance its test by also identifying advanced adenomas, a precancerous polyp type often attributed to CRC. The company hopes that by enabling ColoAlert to accurately detect these polyps it can enable physicians to treat patients before they progress to full-blown colon cancer.

The company is evaluating ColoAlert with these new mRNA biomarkers in the ColoFuture study, an international clinical trial that includes subjects aged 40 to 85 years from participating centers in Germany, Norway, and Denmark. Subjects are invited to participate in the study either when they are referred for colonoscopy (screening or diagnostic) or if they are already diagnosed with colorectal adenocarcinoma but are treatment-naïve, the company said.

On Wednesday morning, the firm announced interim results from 220 subjects showing that the enhanced ColoAlert test showed CRC detection sensitivity of 94 percent with 97 percent specificity, and sensitivity for advanced adenoma of 81 percent — "a level unseen in at-home CRC diagnostic tests up until now," a company spokesperson said in an email.

For comparison, Exact Sciences in June announced top-line data from its BLUE-C study for an enhanced version of its market-leading Cologuard test showing 94 percent sensitivity at 93 percent specificity for CRC detection, 43 percent sensitivity for advanced adenoma, and 75 percent for high-grade dysplasia.

"The data generated from the ColoFuture study exceeded our expectations," Mainz Biomed CEO Guido Baechler noted in a statement. "As we look forward to publishing and presenting the full dataset at a forthcoming medical conference, we eagerly await the outcome from our eAArly DETECT clinical trial which remains on track to report results in Q4 of this year." The company did not specify which medical conference it would present the results at. The eAArly DETECT trial is a US extension of ColoFuture designed to evaluate the integration of the five mRNA biomarkers into ColoAlert.

In December, Mainz Biomed also received approval from an independent institutional review board for the trial protocol of its ReconAAsense study, which will recruit 15,000 individuals in the US to evaluate the clinical performance of ColoAlert to support a US Food and Drug Administration submission. ColoAlert is currently commercially available in select EU countries through independent laboratories, corporate health programs, and direct sales.

At market close on Wednesday, shares of Mainz Biomed were up around 16 percent from the previous day at $4.24.