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

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.

Exact Sciences Corporation (NASDAQ:EXAS) recently expanded its arsenal of cancer screening by announcing an agreement with Jefferson Health to conduct research on a new blood-based, multi-cancer earlier detection (MCED) test.

"We share in Jefferson's deep commitment to building a patient and provider experience that addresses the needs of all populations, including the underserved and vulnerable, so that earlier cancer detection can have the greatest impact," said Kevin Conroy, chairman and CEO of Exact Sciences. "We're thrilled to work with a leading health system like Jefferson to determine how MCED testing can be most effectively implemented and to develop the services required to support patients and primary care physicians."

Quest Diagnostics Incorporated (NYSE:DGX) is another diagnostics provider that currently provides patients with an at-home fecal immunochemic test (FIT) called QuestDirect, that screens for colorectal cancer by looking for hidden blood in the stool.

While the diagnostics giant places an emphasis on early colorectal screening provided by employees, much of the focus for the company over the last two years has leaned towards Covid-19—which has caused Quest Diagnostics to recently raise its full year 2021 guidance ^[9].

"We had a strong third quarter, as COVID-19 molecular volumes increased throughout the summer while our base business continued to deliver solid volume growth versus the prior year and 2019," said Steve Rusckowski, Chairman, CEO and President of Quest Diagnostics. "We have raised our outlook for the remainder of the year based on higher than anticipated COVID-19 volumes as well as the continued progress we expect to see in our base business despite rising labor costs and inflationary pressures. The momentum of our base business positions us to deliver the 2022 outlook we shared at our March investor day."

Last year, sequencing lab Invitae Corporation (NYSE:NVTA) spent $2.3 billion for ArcherDx ^[10], the first genetic lab to offer both tissue and liquid biopsies. Now, the company has recently put out its Q3 2021 financials, reporting $114.4 million in revenue ^[11] driven by 296,000 in billable volume.

Year-over-year growth continued at a fast pace in the third quarter as volumes remained strong across the platform," said Sean George, Ph.D., co-founder and CEO of Invitae. "In particular, progress in the oncology group is reflected in current volumes and preparations for high-value, high-margin product introductions over the coming year, supported by multiple ongoing studies. We look forward to continued robust volume growth in the coming periods as we introduce new testing capabilities and increase access to our lifelong testing and data platform."

These increased measures aren't just restricted to North America. Veracyte, Inc. (NASDAQ:VCYT) recently announced its Immunoscore Colon Cancer test has been included in the Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with localized colon cancer ^[12]. 

Reached from the consensus of 14 experts representing the oncological societies of Japan, China, India, Korea, Malaysia, Singapore and Taiwan, the new Pan-Asian guidelines took into account ethnic differences associated with the treatment of localized colon cancer in Asian patients.

"We are pleased that Pan-Asian experts recognize the utility of the Immunoscore test in localized colon cancer," said Stephane Debono, general manager, Immunoscore and International Diagnostics Operations at Veracyte. "We consider this a significant milestone in our efforts to facilitate reimbursement for the test so that more patients may benefit from its ability to provide important information that may help guide treatment decisions."

To get more information Mainz BioMed (NASDAQ:MYNZ), please visit here.

SOURCES CITED:

[1] https://www.medpagetoday.com/gastroenterology/coloncancer/95551

[2] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2785879?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=110921

[3] https://www.statista.com/statistics/241488/population-of-the-us-by-sex-and-age/

[4] https://finance.yahoo.com/news/mynz-closes-first-day-trading-202300259.html

[5] https://finance.yahoo.com/news/mainz-biomed-exhibit-coloalert-medica-080100560.html

[6] https://pubmed.ncbi.nlm.nih.gov/30336540/

[7] https://mainzbiomed.com/coloalert/

[8] https://mainzbiomed.com/wp-content/uploads/2021/11/MainzBioMed-web-presentation-Nov_5_21.pdf

[9] https://finance.yahoo.com/news/exact-sciences-exas-q3-earnings-133701127.html

[10] https://finance.yahoo.com/news/quest-diagnostics-reports-third-quarter-104500282.html

[11] https://www.annualreports.com/HostedData/AnnualReports/PDF/NYSE_NVTA_2020.pdf

[12] https://finance.yahoo.com/news/invitae-reports-114-4-million-210500213.html

[13] https://finance.yahoo.com/news/veracyte-announces-immunoscore-colon-cancer-121500033.html

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