Should the impressive results from Exact Sciences Corporation's (EXAS) colon and colorectal cancer detection diagnostic test continue through ongoing studies, this company could be positioned to set the standard for the future prevention and early detection of colorectal cancers, of which there are nearly 150,000 new cases per year in the United States alone.
A quote from the Journal of the National Cancer Institute states that colon cancer is the "most preventable, yet least prevented cancer" out there, and it looks like Exact has the answer to that dilemma.
Its non-invasive diagnostic kit, Cologuard, uses molecular screening technology in stool samples to provide early detection for colorectar cancers and has been, thus far, deemed more reliable than the current non-invasive standards of care.
According to published statistics, the FOBT fails to identify "most polyps and some cancers" while also giving false positives that lead to a higher cost of treatment and prevention. The false positives may appear if a patient does not adhere to a specific diet before taking the FOBT, a variable that is not required for Exact's diagnostic.
For a taste of just how accurate the Exact diagnostic is, the company filed an 8k with the SEC this week highlighting some recent study results. According to the 8k, the company presented further validation data for its colorectal cancer screening product at a corporate workshop in Texas at the 2011 Association for Molecular Pathology Annual Meeting . The results presented demonstrated a 98% sensitivity for cancer and 59% sensitivity for advanced adenomas >1 cm, at a specificity cut-off of 91%, utilizing Exact's Cologuard diagnostic on stools from normal, cancer and pre-cancer subjects.
An earlier validation study from 2010 also demonstrated impressive results, with Cologuard demonstrating a rate of 85% sensitivity for cancer at an observed specificity of 88%, while also marking a strong showing for strong pre-cancer detection.
Also according to the 8k, in reference to the 2011 study, "the assay demonstrated a 100% sensitivity for Stage I and Stage II cancers and a 91% sensitivity for Stage III cancers. The test also demonstrated a 96% sensitivity for Stages I, II and III combined. In addition the assay also showed 100% sensitivity for Stage IV cancers. All were at a specificity cut off of 91%."
Exact has also used 2011 to initiate a milestone study that is expected to provide the final data needed for an FDA approval. Over 10,000 subjects are expected to be screened, with full enrollment expected to be met over a period of 12-15 months, which puts the company on track to file with the FDA in late 2012.
If all timelines are met, and thus far there is no reason to believe that they won't be met, that means Cologuard could be on the market shortly thereafter, as Exact is simultaneously building the infrastructure needed to move quickly into the colorectal screening market almost immediately following approval. The potential market for colorectal screening is upwards of a billion dollars annually, in just the US alone, but with prevention and early detection being the theme of today, that mark could grow substantially higher.
The early successes of Cologuard and the heights of its market potential has certainly drawn in increasing investor and analyst interest over the past twelve months.
EXAS has been on the rise throughout 2011, trading as high as over nine dollars after closing 2010 at under six. Numerous analysts have either initiated positive coverage or upgraded their benchmark reccomendations for Exact, which has also attracted the 'big money' needed for a stock to sustain its long term growth.
Exact has a strong portfolio of patents protecting its technology and is being positioned to become a leader in the early detection of colorectal cancer. Governments around the globe are heavily shifting towards the ideal of "prevention and early detection" as a way to combat increasing health care costs, and Exact looks primed to take advantage of that shift with its early detection product that could set the standard for non-invasive colorectal cancer detection.
Keep an eye on this developing story, as the Exact Sciences story is starting to make its rounds, with increasing company attendance at various investor conferences and study results that are grabbing analyst attention.
Disclosure: No position.