NEW YORK, Nov. 11, 2021 /PRNewswire/ -- New recommendations for colorectal cancer (CRC) screening by both the US Preventative Services Task Force (USPSTF) and from the US Food and Drug Administration are ensuring benefits realized by all—all by moving up the starting screening age of adults from 50 down to 45. In turn, market researchers are forecasting a CAGR growth of 8.5% and an overall expansion of the market by 2.2x through 2031 in the global colorectal cancer diagnostics market. According to Pew, more FDA approved in vitro diagnostic (IVD) tests and lab-developed tests (LDTs) are increasingly needed. Just in time for this surging new demand of diagnostic options, there has been plenty of innovation in the field of colorectal cancer screening, from developers such as Mainz BioMed B.V. /zigman2/quotes/230703458/composite MYNZ +26.95% , Exact Sciences Corporation /zigman2/quotes/206653925/composite EXAS +4.02% , Guardant Health /zigman2/quotes/201348336/composite GH -1.55% , Illumina /zigman2/quotes/203509482/composite ILMN +1.41% , Pacific Biosciences of California 'PacBio' /zigman2/quotes/203185043/composite PACB -5.83% .
Newly IPO'd Mainz BioMed B.V. /zigman2/quotes/230703458/composite MYNZ +26.95% is priming itself for a jump from Europe into the US market, with its flagship product ColoAlert—which is a non-invasive colorectal screening test that can be taken at home, with a rapid response and 92% specificity.
ColoAlert is already approved for commercial sale in the EU, and is currently developed out of its home country of Germany. The test is categorized as a non-invasive molecular genetic colorectal early detection stool test in combination with the fecal immunochemistry test (FIT) that's simple, fast, and accurate.
Mainz claims on its website that ColoAlert can deliver up to 60% fewer missed cases when compared to fecal immunochemical tests (FIT). According to internal data on the product, 98% of the patients who responded to an internal survey expressed satisfaction with the easy-to-use product.
In many ways, Mainz's ColoAlert product is expected to challenge its leading competitor, ColoGuard, manufactured and sold by Exact Sciences Corporation /zigman2/quotes/206653925/composite EXAS +4.02% .
There are many differences, however, including price points, and distribution, as ColoAlert is expected to use a decentralization business strategy by selling directly to a wide range of regional and national laboratory service providers, whereas all ColoGuard tests are currently analyzed through Exact Sciences' central laboratory.
ColoAlert has already received CE accreditation and is approved for sale in Europe, meaning Mainz BioMed will already have its established relationships with international distributors making for a smooth transition into other markets, should more approvals come down the line.
Mainz BioMed has stated that its FDA clinical study process for ColoAlert is set to be launched in H1 2022.
For Q3 2021, Exact Sciences Corporation /zigman2/quotes/206653925/composite EXAS +4.02% recently released its financial results, showing that the company generated revenue of $456.4 million—up 11.75% over the same period in 2020. Screening revenue alone for the company was $280.4 million, representing an increase of 31% year over year.
" Exact Sciences is entering an exciting period for its pipeline, generating evidence to support innovative tests that will help defeat cancer through earlier detection," said Kevin Conroy, chairman and CEO of Exact Sciences . "Our powerful commercial engine will help us achieve our mission by getting more people tested with Cologuard [®] , Oncotype DX [®] , and our future tests."
Recently genetic-screening company Illumina's /zigman2/quotes/203509482/composite ILMN +1.41% CEO Francis deSouza gave an interview with the Wall Street Journal about his company's breakthrough subsidiary start-up Grail, as a cancer diagnosing blood test.
"We know that cancer kills about 10 million people a year—about 600,000 in the U.S. And we know that even for some of the deadliest cancers, your odds of survival are much higher if you catch the cancer in stage 1 or stage 2," said Illumina CEO Francis deSouza. "So a blood test that can catch cancer early can truly be life-changing."
Grail doesn't pick up every cancer, but it can detect the 12 deadliest cancers with 60% accuracy, and has a false-positive rate of less than 1%.
"Today, there is nobody who is even starting the studies to develop a 50-cancer test like Grail, and once you start the study, it's still a few years before you actually get the test," adds deSouza. "We think there will also be blood tests for single cancers, for colorectal cancer and other cancers. Those won't compete with Grail. They will be complementary to Grail."
Data presented at the American College of Gastroenterology's Annual Scientific Meeting showed that the LUNAR-2 blooed test from Guardant Health /zigman2/quotes/201348336/composite GH -1.55% offered optimized sensitivity and specificity in identifying average-risk patients with early-stage CRC. The LUNAR-2 blood test aims to detect early-stage cancer in screen-eligible asymptomatic adults from a simple blood draw.
"CRC screening saves lives, but we know that only about two-thirds of individuals get screened for CRC because current options, like a colonoscopy, are invasive and the preparation can be challenging, and other modalities, like stool based testing, have their own challenges to screening adherence," said AmirAli Talasaz, Guardant Health Co-CEO. "The study results show that the LUNAR-2 test could provide both patients and physicians with an easy-to-use and highly accurate CRC screening alternative in the form of a blood test."
Pacific Biosciences of California 'PacBio' /zigman2/quotes/203185043/composite PACB -5.83% is set to provide its Sequl IIe sequencing platforms to leading global genomics and diagnostic testing company, Prenetics Groups Limited —as the first is adding more comprehensive genetic screening services in Hong Kong, Southeast Asia and the UK.
Prenetics is using PacBio technology to apply epigenomics to both end-consumer oriented products, including medically-oriented products such as colorectal cancer and liver cancer.
"The pairing of PacBio and Prenetics doesn't just offer opportunities in consumer genetic testing, but shows how Sequel IIe can be used to make advances in biomedical research, clinical diagnostics and pharmaceutical solutions," said Jonas Korlach, Chief Scientific Officer at PacBio . "We're very excited to see how our HiFi technology is being used by scientists all around the world to advance science."
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