Exact Sciences Colon Cancer Screen FDA Approval a Total Game-Changer

By Jon C. Ogg Published Aug 12, 12:21PM EDT

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Accurate colon cancer screening has usually involved a colonoscopy, an invasive and unpleasant procedure many chose to avoid. But on Monday, the Food and Drug Administration approved the first and only non-invasive stool DNA colorectal cancer screening test from Exact Sciences Corp. (NASDAQ: EXAS).

The new test is called Cologuard, and it is the first time in history that a technology received both FDA approval and was proposed for national coverage by Centers for Medicare and Medicaid Services (CMS) on the same day. The results are game-changing as the Cologuard screening test detects a whopping 92% of colorectal cancer results.

Unlike other screening options, Cologuard does not require medication or dietary restrictions — and most importantly for those who have undergone a colonoscopy, it does not require bowel preparation prior to taking the test. Cologuard will be available to patients through their healthcare providers in the United States for $599.

The stool DNA colorectal cancer screening test analyzes both stool DNA and blood biomarkers. In a study, Cologuard detected 92% of cancers and 69% of the most advanced precancerous polyps in average risk patients.

Exact Sciences said,

“An estimated 23 million Americans between 50 and 75 are not getting screened as recommended and as a result, colorectal cancer remains the second-leading cancer killer in the U.S. For those whose cancer is detected at an earlier stage, the five-year survival rate can be greater than 90 percent.”

Cologuard is to be available through healthcare providers and aims to offer those patients who are 50 and older with average colorectal cancer risks an in-home screening test. A final national coverage determination is expected to be posted in October or November of 2014 after a public comment period.

The FDA approved Cologuard after reviewing trial results from 90 sites and 10,000 patients.

It is unsurprising that Exact Sciences shares are rallying on the news. The stock hit a 52-week high, also an all-time high, of $19.37 earlier on Tuesday. After almost two hours of trading, the stock pulled back somewhat to $18.20, but the 9.5 million shares that had changed hands was already about nine times the normal trading volume. This also marks the highest trading volume going back over a year, since the 21 million shares that traded on April 18, 2013, when the stock was briefly under $9.00.

ALSO READ: New Analyst Biotech Stock Picks That Could Double

One thing we would point out before the analysts get their revenue targets changed. Thomson Reuters shows that the consensus revenue estimate is expected to rise to only $74.3 million in 2015 from only about $2.1 million in 2014. The consensus price target was about $19.25, and the highest analyst target was $25.

About the Author Jon C. Ogg →

Jon Ogg has been a financial news analyst since 1997. Mr. Ogg set up one of the first audio squawk box services for traders called TTN, which he sold in 2003. He has previously worked as a licensed broker to some of the top U.S. and E.U. financial institutions, managed capital, and has raised private capital at the seed and venture stage. He has lived in Copenhagen, Denmark, as well as New York and Chicago, and he now lives in Houston, Texas. Jon received a Bachelor of Business Administration in finance at University of Houston in 1992. a673b.bigscoots-temp.com.