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MADISON, Wis. - Exact Sciences Corp. (NASDAQ:EXAS) announced Wednesday that its Oncodetect molecular residual disease test has secured Medicare coverage through the Centers for Medicare & Medicaid Services for patients with stage II, III, and resectable stage IV colorectal cancer.
The coverage, approved through the Molecular Diagnostic Services Program, allows for serial use of the test in adjuvant and recurrence monitoring settings over a five-year period, according to a company press release. According to InvestingPro data, Exact Sciences maintains a healthy current ratio of 2.73, indicating strong operational stability to support this expansion.
The Oncodetect test is designed to track up to 200 circulating tumor DNA variants and can potentially identify cancer recurrence up to two years earlier than imaging alone. The test provides quantitative assessment of circulating tumor DNA to help healthcare providers understand a patient’s molecular residual disease status.
"Gaining Medicare coverage for the Oncodetect test is a meaningful step forward in expanding access to earlier, more personalized insights for patients with colorectal cancer," said Brian Baranick, Executive Vice President and General Manager of Precision Oncology at Exact Sciences.
The company stated that more than three million Americans are eligible for molecular residual disease testing across multiple solid tumors. Exact Sciences is pursuing additional Medicare coverage for other solid tumor indications. With a robust gross profit margin of 69.8%, the company appears well-positioned to capitalize on this market opportunity. InvestingPro subscribers can access additional insights, including 6 more key tips about Exact Sciences’ growth potential.
The test’s clinical validation is supported by studies including Beta-CORRECT, which the company describes as its largest molecular residual disease clinical study to date, confirming the test’s prognostic capabilities across stages II-IV colorectal cancer.
Exact Sciences’ portfolio includes other cancer screening and diagnostic tests such as Cologuard and Oncotype DX. Three analysts have recently revised their earnings estimates upward, with expectations of profitability in 2025, suggesting growing confidence in the company’s strategic direction.
In other recent news, Exact Sciences Corporation reported notable developments in its first-quarter 2025 earnings. The company achieved a revenue of $707 million, surpassing Wall Street estimates of $688.78 million, marking an 11% increase year-over-year. However, the earnings per share (EPS) showed a loss of $0.54, which was deeper than the anticipated loss of $0.33. Despite this, Exact Sciences raised its full-year revenue guidance to a range of $3.070-$3.120 billion, reflecting the company’s confidence in its strategic initiatives and product launches like Cologuard Plus.
Additionally, during the 2025 Annual Meeting, shareholders approved the 2025 Omnibus Long-Term Incentive Plan and an amendment to the Employee Stock Purchase Plan. These plans are designed to attract and retain talent through stock-based compensation and cash incentives. Shareholders also ratified the appointment of PricewaterhouseCoopers LLP as the independent registered public accounting firm for the fiscal year 2025.
In the realm of governance, the election of seven board directors was confirmed, although a stockholder proposal concerning a director election resignation governance policy was not approved. These recent developments highlight Exact Sciences’ focus on growth and governance as it continues to expand its market presence and product offerings.
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