BOSTON ( TheStreet) -- Welcome to this week's Biotech Stock Mailbag.
Steven D. writes, "I have been long Exact Sciences (EXAS) for a number of years waiting for their pivotal study to read out. Any idea on the timing of the study and views from the short side of the trade?"
Top-line results from Exact Sciences' pivotal "Deep-C" study of Cologuard are expected before the end of April. Steven is right, the wait has been long, so let's go over the study design and talk about expectations.
The Deep-C study evaluates Cologuard as a new, non-invasive screening test for colon cancer and pre-cancerous lesions. Cologuard isolates and identifies cancerous and pre-cancerous DNA from a patient's stool sample. Exact Sciences designed Cologuard to more accurately detect early stage colon cancer and pre-cancerous lesions compared to the existing stool-based screens FOBT and FIT, which can pick up 40-60% of colon cancers and are even less accurate in detecting pre-cancerous lesions.Cologuard isn't necessarily designed to be more sensitive than a colonoscopy, but Exact Sciences argues that adoption of the non-invasive and easy-to-use Cologuard will lead to higher colon cancer screening rates. (Half of Americans recommended for colon exams choose not to be tested.) Used ahead of colonoscopy, Cologuard could also improve the detection of pre-cancer and early stage cancer when it is most treatable and curable. More than 10,000 patients at average risk for colon cancer were enrolled in the Deep-C study. Each patient in the study receives a colonoscopy while a sample of their stool is also tested with Cologuard and a FIT test. The study's primary endpoint compares the sensitivity and specificity of Cologuard to colonoscopy. Secondary endpoints will compare Cologuard to colonoscopy in the detection of pre-cancerous lesions, and non-inferiority between Cologuard and FIT. The target performance for Cologuard is 85% sensitivity and 90% specificity. Are these targets achievable? Yes, easily, given the available screening data already presented. Exact Sciences has conducted three validation studies of Cologuard overall. The last two studies conducted in 2011 and 2012 were the most relevant and yielded colon cancer sensitivity rates of 98% each time. Importantly, sensitivity rates for stage 1 and 2 colon cancers were just as high. For pre-cancerous lesions, the sensitivity rates were 59% and 57%, respectively.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV