MADISON - Exact Sciences Corp. (NASDAQ:EXAS), a prominent player in cancer screening and diagnostics, announced the commencement of its Falcon Registry study for Multi-Cancer Early Detection (MCED) at Baylor Scott & White Health in Texas. The study aims to enroll up to 25,000 participants to evaluate the clinical utility of MCED testing in real-world settings. Endeavor Health in Illinois will also join the study this fall, enrolling patients to further the research.
The study, authorized by the FDA under an investigational device exemption, will investigate the impact of MCED testing on patient care. It will track up to 25,000 patients aged 50-80 with no cancer history over five years, including three years of annual MCED testing and two additional years of follow-up data collection. A comparator cohort of up to 50,000 patients, receiving standard care without the MCED test, will also be evaluated.
The MCED test developed by Exact Sciences is designed to detect cancers early, utilizing biomarkers that indicate the presence of cancer with high sensitivity and specificity. This test is particularly significant for aggressive cancers that currently lack standard screening methods.
Dr. Ronan Kelly, the study's principal investigator at Baylor Scott & White Charles A. Sammons Cancer Center, expressed enthusiasm for the study's potential to contribute to national cancer mortality reduction goals. Dr. Peter Hulick of Endeavor Health highlighted the study's alignment with efforts to implement preventative genomics and improve early diagnosis and personalized treatment options.
Cancer remains a leading cause of death in the U.S., with over 2 million new cases and about 611,000 deaths expected in 2024. The Falcon Registry study is seen as a critical step in advancing early cancer detection and potentially transforming cancer care. The study will also include diverse populations from Baylor Scott & White and Endeavor Health, providing insights into the benefits of early detection across various communities.
The Exact Sciences MCED test, while not yet cleared or approved by the FDA for commercial use, is available to patients enrolled in the Falcon Registry study. The test is conducted at Exact Sciences Laboratories, which is CAP accredited and CLIA certified for high-complexity clinical laboratory testing.
This news is based on a press release statement and does not imply endorsement of the study's claims or potential outcomes. Exact Sciences continues to focus on its pipeline development, including the MCED test, to offer innovative solutions for cancer detection and diagnosis.
In other recent news, Exact Sciences Corporation has reported a robust performance in its second quarter earnings report. The company's revenues climbed to $699 million, a 12% year-over-year increase, driven by the screening of over 1 million people using its Cologuard test and record numbers of global patients tested with Oncotype DX. Furthermore, Exact Sciences is making significant strides in the development of new diagnostic tests, including the anticipated launch of Cologuard Plus and Oncodetect, and its blood-based colon cancer and multi-cancer screening tests.
In addition to these developments, the company has underlined its growth trajectory by reaffirming its full-year revenue guidance and raising its adjusted EBITDA outlook. The company also announced a new license agreement with TwinStrand, which will strengthen its patent portfolio. Lastly, the FDA has authorized a real-world evidence study for the multi-cancer screening test, which has detected 51% of cancers across 21 types. These are among the recent key developments for Exact Sciences Corporation.
InvestingPro Insights
As Exact Sciences Corp. (NASDAQ:EXAS) embarks on its groundbreaking Falcon Registry study for Multi-Cancer Early Detection, it's worth noting the company's recent performance and financial health. According to InvestingPro data, Exact Sciences has a market capitalization of $10.9 billion, indicating a significant presence in the biotechnology sector. Despite not being profitable over the last twelve months, the company shows a strong return over the past month of 25.98% and an impressive three-month return of 15.63%. This growth momentum could reflect investor confidence in the company's ongoing projects and future prospects.
One InvestingPro Tip highlights that Exact Sciences' liquid assets exceed its short-term obligations, which suggests a stable financial position that could support its ambitious research initiatives like the Falcon Registry study. The company's revenue growth also stands out, with a 13.54% increase over the last twelve months as of Q2 2024, demonstrating its ability to expand its operations amidst challenging market conditions. This growth is pivotal as the company invests in research and development to achieve breakthroughs in early cancer detection.
While analysts do not anticipate Exact Sciences will be profitable this year, the company's strategic investments in research, such as the MCED test, may pave the way for long-term success. For readers interested in a deeper dive into the company's financial metrics and future outlook, there are additional InvestingPro Tips available at https://www.investing.com/pro/EXAS.
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