Rising Cases of Early-Onset Colorectal Cancer Calls for Expanded Biotech Screening Methods

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NEW YORK, Dec. 1, 2021 /PRNewswire/ -- Early onset colorectal cancer is currently on the rise ^[1], according to a new study ^[2] from the University of Colorado School of Medicine in Denver. The findings come just as the US Multi-Society Task Force on Colorectal Cancer updated its screening recommendations to include individuals aged 45 to 49 years, adding close to 20 million ^[3] more Americans with the routine change. In order to tackle the seriousness of this rising risk, several biotech companies are answering the call, including Mainz BioMed B.V. (NASDAQ:MYNZ), Exact Sciences Corporation (NASDAQ:EXAS), Quest Diagnostics Incorporated (NYSE:DGX), Invitae Corporation (NYSE:NVTA), and Veracyte, Inc. (NASDAQ:VCYT).

Recently Mainz BioMed B.V. (NASDAQ:MYNZ) made a splash on its IPO day, gaining roughly . The company is currently working towards bringing its flagship non-invasive colorectal cancer screening product ColoAlert over from Europe to the USA. The test that can be taken at home, with a rapid response and 92% specificity, and most recently, Mainz exhibited at the world's largest medical trade fair, MEDICA 2021 ^[4].

Developed out of Mainz's home country of Germany, ColoAlert is already approved for commercial sale in the EU. It detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy ^[5]. Mainz claims on its website that ColoAlert can deliver up to 60% fewer missed cases when compared to fecal immunochemical tests (FIT) ^[6].

According to Mainz's internal data on ColoAlert, 98% of the patients who responded to an internal survey expressed satisfaction with the product. Mainz BioMed has stated that its FDA clinical study and submission process for ColoAlert is set to be launched in Q4 2021 ^[7].

Once approved in the U.S., Mainz's commercial strategy is to establish scalable distribution through a collaborative partner program selling directly to a wide range of regional and national laboratory service providers, unlike its closest competitor ColoGuard from Exact Sciences Corporation (NASDAQ:EXAS) whose tests are currently analyzed through Exact Sciences' central laboratory.

Based on a review of public disclosure, Mainz's ColoAlert product is well positioned to challenge Exact Sciences's leading competitor product, ColoGuard.

Despite its earnings and revenues ^[8] beating its Q3 2021 estimates, Exact Sciences Corporation (NASDAQ:EXAS) recently saw its shares drop after guiding lower screening revenue for fiscal year 2021, which analysts attributed to a surge in COVID-19 cases.