MADISON, Wis. - Exact Sciences Corp. (NASDAQ: NASDAQ:EXAS), a prominent cancer screening and diagnostics company, announced today that the U.S. Food and Drug Administration (FDA) has approved the Cologuard Plus test for colorectal cancer (CRC) screening in adults aged 45 and older at average risk. The approval is based on the results of the BLUE-C study, a large prospective trial comparing the Cologuard Plus test to an independent fecal immunochemical test (FIT).
The study demonstrated that the Cologuard Plus test has a 95% sensitivity for detecting colorectal cancer and a 43% sensitivity for advanced precancerous lesions, with a 94% specificity. These figures indicate a significant improvement over the current Cologuard test, with a more than 30% reduction in false positives. The Cologuard Plus test is expected to lessen unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive result.
Exact Sciences anticipates that the Cologuard Plus test will be commercially available in 2025 with Medicare coverage and inclusion in U.S. Preventive Services Taskforce (USPSTF) guidelines. The company aims to build upon the success of the original Cologuard test, which has been used over 17 million times and has contributed to improving national CRC screening rates.
The Cologuard Plus test, developed in collaboration with Mayo Clinic, incorporates novel biomarkers and improved laboratory processes to enhance its performance. As part of Exact Sciences' commitment to accessible and effective cancer screening, the test is designed to be non-invasive and can be completed at home without special preparation.
The BLUE-C study, which underpins the FDA approval, enrolled a diverse set of over 20,000 adults and directly compared the Cologuard Plus test to FIT using colonoscopy as a reference. The study's diverse enrollment aimed to ensure the relevance of its findings across different racial and ethnic groups.
Exact Sciences is preparing for the commercialization of the Cologuard Plus test, which will be supported by the company's commercial organization and the ExactNexus technology platform, streamlining the process for health systems.
This news is based on a press release statement from Exact Sciences Corp. and does not constitute an endorsement of the Cologuard Plus test or any claims regarding its performance. The information provided is intended for general news purposes only.
In other recent news, Exact Sciences Corporation has maintained its Buy rating from TD Cowen, despite a setback in product pricing for its Cologuard Plus test. The company plans to counter this challenge by using the Advanced Diagnostic Laboratory Test pathway to secure a price increase. Other recent developments include a reaffirmed Buy rating and steady price target from Canaccord Genuity following the presentation of new performance data for the company's blood-based colorectal cancer screening test. The test demonstrated a sensitivity of 88% for detecting colorectal cancer and 31.2% sensitivity for advanced adenomas.
Analyst firms BTIG, Citi, and Piper Sandler have updated their perspectives on Exact Sciences, raising their price targets to $82, $80, and $85 respectively. Exact Sciences has reported a year-over-year revenue increase of 12%, reaching $699 million in its second quarter earnings, primarily driven by the use of its Cologuard test by over a million people and record global patient testing with Oncotype DX.
The company has also initiated the Falcon Registry study for Multi-Cancer Early Detection at Baylor Scott & White Health in Texas, aiming to enroll up to 25,000 participants. The company is anticipating the results of the BLUE-C blood readout, now slated for the first half of 2025, and suggests that its test could potentially match the sensitivity of the fecal immunochemical test with these forthcoming results. These are the recent developments for Exact Sciences Corporation.
InvestingPro Insights
The FDA approval of Exact Sciences Corp.'s (NASDAQ: EXAS) Cologuard Plus test marks a significant milestone for the company, potentially bolstering its market position in cancer diagnostics. This development aligns with the company's recent financial performance and market trends.
According to InvestingPro data, Exact Sciences has shown strong revenue growth, with a 13.54% increase in the last twelve months as of Q2 2023, reaching $2.61 billion. This growth trajectory could be further accelerated by the introduction of Cologuard Plus in 2025.
Despite the positive news, investors should note that Exact Sciences is currently not profitable, with a negative operating income of $282.27 million in the last twelve months. An InvestingPro Tip highlights that analysts do not anticipate the company to be profitable this year. However, the improved specificity of Cologuard Plus could potentially lead to increased adoption and improved financial performance in the future.
The market has responded positively to recent developments, with Exact Sciences showing a strong return of 53.76% over the last three months. This performance suggests investor optimism about the company's prospects, including the potential impact of Cologuard Plus.
It's worth noting that Exact Sciences has a price-to-book ratio of 3.84, indicating that investors are willing to pay a premium for the company's assets, possibly due to its growth potential in the cancer diagnostics market.
For investors seeking a more comprehensive analysis, InvestingPro offers 6 additional tips for Exact Sciences, providing deeper insights into the company's financial health and market position.
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