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MADISON, Wis. - Exact Sciences Corp. (NASDAQ:EXAS), a leader in cancer screening and diagnostic tests with a market capitalization of $10 billion, announced clinical validation data for its OncodetectTM MRD test, highlighting its strong association with recurrence in stage III colon cancer patients. The test is set to be launched in the second quarter of 2025 with Medicare coverage. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 2.12, though analysts don't expect profitability this year. The stock currently appears fairly valued based on InvestingPro's Fair Value analysis.
The data, presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, showed that the Oncodetect test achieved a sensitivity of 78% post-surgery and 91% during the surveillance period. Specificity rates were reported at 80% and 94%, respectively. These results primarily involved stage III colon cancer patients, with the complete study findings to be published in a peer-reviewed journal on January 25. The company has demonstrated solid revenue growth of 11.91% over the last twelve months, with an impressive gross profit margin of 72.96%.
In addition to the data presented at the symposium, the Oncodetect test reached its primary endpoint in the Beta-CORRECT study, demonstrating its prognostic value in stage II and IV colon cancer as well as rectal cancer. The findings from this study confirmed the significant link between MRD positivity and recurrence in patients with stage III colon cancer and will be presented at an upcoming scientific conference.
Dr. Takayuki Yoshino, deputy director at the National Cancer Center Hospital East in Japan, expressed optimism about the implications of the Oncodetect test for improving residual cancer monitoring after surgery.
Exact Sciences aims to provide the Oncodetect test across the U.S. through its Precision Oncology platform, leveraging its existing relationships and technologies to ensure widespread access to MRD testing.
The company has also entered strategic partnerships with the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Flatiron Health to generate additional clinical evidence across multiple solid tumor types. These collaborations include studies such as CORRECT-I and CORRECT-II, assessing the association between circulating tumor DNA (ctDNA) and recurrence in colorectal cancer, and EXActDNA-003, one of the largest prospective MRD studies in early-stage breast cancer.
Dr. Norman Wolmark of the NSABP Foundation highlighted the potential of ctDNA analysis to revolutionize recurrence detection through these studies.
Exact Sciences' MRD offerings utilize whole exome sequencing to detect and monitor residual cancer in patients with solid tumors, providing personalized insights that can guide therapy decisions.
This report is based on a press release statement. Exact Sciences has not provided any forward-looking statements regarding the commercial performance of Oncodetect in this announcement.
In other recent news, Exact Sciences has seen considerable developments, particularly with the approval of Cologuard Plus by the U.S. Food and Drug Administration. Analyst firms CFRA, BTIG, TD Cowen, Piper Sandler, Leerink Partners, Bernstein SocGen Group, Stifel, and Wolfe Research have responded positively to the news, upgrading their ratings or maintaining their positive outlooks. The Centers for Medicare & Medicaid Services have increased the Clinical Laboratory Fee Schedule rates for the Cologuard Plus test, marking a 16% increase over the original test's price. This is expected to boost the company's revenue and contribute to long-term margin expansion. Exact Sciences' Q3 2024 earnings revealed a 13% year-over-year revenue increase, reaching $709 million, and a substantial 75% increase in adjusted EBITDA to $99 million. The company has revised its full-year revenue guidance to between $2.73 billion and $2.75 billion, with adjusted EBITDA expected to be between $310 million and $320 million. These are among the recent developments from Exact Sciences Corporation, underlining its dedication to financial growth and advancements in cancer detection.
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