Mainz BioMed developing new version of ColoAlert assay

These have been the days of a whirlwind for German diagnostics company Mainz Biomed, which is selling a PCR-based test to detect early-stage colorectal cancer called ColoAlert.

firm this week secure a deal with a large German regional lab to offer CE-IVD-marked testing in its home market, and earlier this month announced it had launched a clinical studies Of mRNA markers associated with precancerous polyps and lesions.

According to CEO Guido Baechler, the firm is now manufacturing a third-generation version of ColoAlert, which it intends to submit to the US Food and Drug Administration within three years.

“The next big market for us is the US,” said Backler, a Switzerland native who has 30 years of industry pedigree, 20 of which was spent working at Roche, particularly in its diagnostics division. Backler has lived in California for the past 25 years, and now runs the Mainz BioMed office in Berkeley, although the firm continues to be headquartered in Mainz, Germany.

“Once you have FDA approval and reimbursement established, you can go anywhere,” Baechler said of Mainz’s US opportunity. He added that the company has already brought in consultants to “think through regulatory strategy in the US” and is selecting contract research organizations to support its path.

Mainz has made several appointments since Bakler came on board last July. In January, it tapped Steve Quinn, formerly the commercial director at ProGenity, was its vice president of business development. In December, it was added Karen Richardsformer senior vice president in vitro To be its Vice President of Diagnostics and Quality, Regulatory Affairs at Precision for Medicine. Mainz’s Strategic Advisory Board is also growing, with Heiner DreismannThe former CEO of Roche Molecular Systems, recently joined. Michel Pedrocchi, former head of Roche Diagnostics business development, also joined the strategic advisory board in January.

company in November raised $10 million in an initial public offering and began trading on the Nasdaq and then raised an additional $25.5 million in a share offering in January. Meanwhile the company licensed marker From a group at the Universite de Sherbrooke in Quebec that it intends to join ColoAlert to expand its detection capabilities, and began clinical studies of those markers. According to Bechler, the study, called ColoFuture, will involve more than 600 male and female patients, aged 40 to 85, who have been referred for colonoscopies.

“You see a lot of momentum now because we’re bringing additional players on board and we’ve licensed those biomarkers as well,” Bechler said. “It’s a combination of Bay Area, Silicon Valley, ‘Let’s get it done tomorrow’ [mentality] combined with a more traditional, European approach.”

In fact, the story of ColoAlert has been a rather slow-moving European story for the past six months. The ColoAlert assay was initially developed by a company of the same name, based in Sandnes, Norway, which subsequently collaborated with Germany-based PharmGenomics, which specialized in multiplexing technology, to refine its detection assay. Participated.

“They optimized the extraction, optimized the PCR profile, and then marked it CE and started commercializing it and decided to go public,” Bechler said. “That was when I came in.”

PharmGenomics, a 13-year-old company with 22 employees, reformed as Mainz Biomed before its IPO last year. ColoAlert AS remains an independent entity, and Mainz Biomed has a perpetual and exclusive license with ColoAlert AS, Baechler said.

According to Bachelor, he was attracted to this opportunity because of the decentralized testing strategy around the kit. Mainz BioMed sells its kits to laboratories, which then use their own sales and marketing resources to reach primary care physicians. The approach was also in line with some of the work he did at Roche Diagnostics, which was based on a decentralized testing strategy, rather than running all assays in-house in a CLIA-compliant laboratory.

“Everybody has a centralized lab concept,” Bechler said. “I’ve built two CLIA labs before, so I understand the advantages and disadvantages of CLIA labs,” he said. “It’s very different, and that’s why I’m excited about this story.”

Why is decentralized testing better, at least in this case? Baechler said such an approach enables Mainz BioMed to collaborate with other large laboratories, improving sales efficiency and reducing its marketing costs.

This direction may also give Mainz BioMed an advantage against competitors, among which are exact scienceColoGuard, which offers a DNA-based colorectal cancer screening test. Samples are collected at home and shipped to Exact’s lab in Wisconsin, an approach that is, in Baechler’s words, “a time-consuming and costly process.” In contrast, Mainz BioMed’s model involves partnering with multiple third-party laboratories in different regions for test kit processing, making the solution more widely available, he said. Darik.News