ADVERTORIAL
Could an FDA Approval Send This Game-Changing Cancer Detection Stock To a New Dimension?
Editorial Feature | April 28, 2023 | Industry
Introducing a Breakthrough Test for Early Screening of Deadly Cancers
Remember the shocking news of Black Panther star Chadwick Boseman’s tragic death from colon cancer?1
It wasn’t the fact that Boseman hid his illness from the world until his final days that stunned fans. It was because he wasn’t even 40 years old when he received the stage 3 diagnosis.
Up until that point, most people thought colon cancer only affected people aged 55 and up, but the truth is colon cancer rates are rising dramatically among young and middle-aged adults.
The good news is that colon cancer is actually one of the most preventable with proper screening and we’ve discovered an under-the-radar small-cap stock that is dedicated to saving lives by transforming at-home cancer detection.
For a small-cap stock, getting approval from the Food and Drug Administration (FDA) for a drug or a diagnostic device can be the game changer that sends its value soaring.
That’s why there’s one stock investors should be watching closely right now.
At a market cap of only $80 million, it’s a small-sized biotech company with blue sky written all over it. The company has successfully completed its pre-submission process with the FDA for its PMA pivotal clinical trial for ColoAlert in 2023. That means that FDA approval could potentially be in the near future and if that happens, it could send this company into a new dimension.
To put it in perspective, despite generating over $2 billion in revenue, their closest rival’s product pales in comparison.
Plus, this company boasts a stacked roster of renowned scientists and oncology experts, many of whom have an impressive track record of experience at top companies like Roche, Abbott Laboratories, PharmGenomics, Deloitte, and Danaher, just to name a few.
The Silent Disease: Colon and Pancreatic Cancer
Two of the most dangerous forms of cancer are those that afflict the colon and pancreas. One of the main problems with both of these cancers is the lack of screening options. Many cases go undetected until it is too late.
According to the American Cancer Society, about 1 in 23 men and 1 in 26 women will develop colorectal cancer during their lifetime. 2 In Canada, it’s estimated that 1 in 16 men and 1 in 19 women will develop this type of cancer.3
Colon cancer is often considered a “silent” disease, meaning it usually has no symptoms. Symptoms that may occur include changes in bowel habits, abdominal pain, blood in the stool, and weight loss.
Meanwhile, pancreatic cancer is less common, as the 12th most common new cancer each year. Unfortunately, it is also the 4th leading cause of cancer deaths, after lung, colon, and breast cancers. This means that even though about 48,000 people are diagnosed each year, nearly the same number (40,000) will die from it. 4
One of the biggest factors of success comes from early detection. What we know today though is that nearly half of all cancer deaths worldwide are preventable5 as many cancers are caused by preventable risk factors.6
Recent studies show that screening colonoscopies can reduce the relative risk of getting colon cancer by 52% and the risk of dying from it by 62%.7
But colonoscopies are costing patients more and more, and many are looking towards more non-invasive screening methods, much like that of their proprietary technology, ColoAlert.
Differentiated Business Model
The company is currently selling ColoAlert in Europe by working with other labs instead of having their own lab.
The strategy involves giving ColoAlert to these labs, who can put their own name on it, and the labs buy the special kits when they need them. Then, the labs can help doctors and patients find colorectal cancer early by using ColoAlert.
DNA extraction for ColoAlert is now automated on the Thermo ScientificTM Apex, representing an essential partnership that enables labs around the world to increase their testing capacity and optimize their resource allocation—and allowing for analyzing up to 96 samples per run, in roughly two hours.
On top of that, the company is also advancing its technology, having reported positive results from its Feasibility Study evaluating its portfolio of novel mRNA biomarkers for early detection of advanced colorectal adenomas.8
The Pivotal FDA Study
The FDA now thinks that people should get checked by screening once every three years when they turn 45 years old.9 In order to get there, the American Cancer Society recommends two categories of tests: stool-based tests, and visual tests.10
Among the easiest screening methods is ColoAlert, which has to-date delivered a 98% patient satisfaction rate11 and delivers up to 60% fewer missed cases compared to fecal immunochemical tests (FIT).12
But ColoAlert won’t be sold in the US until it receives proper FDA approval, and sure enough, this company is on its way towards achieving that. Late in 2022, they received approval from an independent Institutional Review Board (IRB) for the US pivotal study to evaluate the clinical performance of ColoAlert. That brings the company closer to an FDA approval that would greatly open up the market potential for their flagship asset.13
ColoAlert is already approved in the EU, having achieved a new level of regulatory compliance in 2022.14 The product is CE-IVD marked (complying with EU safety, health, and environmental requirements) and is transitioning to compliance with In Vitro Diagnostic Devices Regulation (IVDR). It’s commercially available in a selection of countries in the European Union.
Now there’s an international clinical trial underway evaluating over 600 patients (women or men) in the age range of 40-85 at two participating centers in Norway and two in Germany.
What to do now…
With EU approval and sales already underway in that market This companyis poised for big things in the global cancer detection market, as we await the results of their FDA clinical study, due in 2025.
With these studies already underway, you can expect this company and ColoAlert news flow over the next few months to come very fast, with the potential for many of the same game-changing developments and milestones witnessed in the ColoGuard story.
To learn more about this innovative company, and stay up to date on their story, sign up with your best email address below.
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