Latest news with #CologuardPlus
Business Wire
31-07-2025
- Health
- Business Wire
Exact Sciences and Humana Expand Colorectal Cancer Screening Partnership with Cologuard Plus™ Test
MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced an expanded partnership with Humana Inc. to enhance access to colorectal cancer (CRC) screening. Through the partnership, the Cologuard Plus™ test will be available as an in-network service for eligible Humana Medicare Advantage members nationwide beginning in August 2025. Humana, the fourth largest private insurer in the United States, has approximately 5.8 million Medicare Advantage members. 'The Exact Sciences team is proud to expand access to Cologuard Plus through our collaboration with Humana, making it easier for more people to access this revolutionary, non-invasive colorectal cancer screening test from the comfort of home,' said Jake Orville, Executive Vice President and General Manager, Screening. 'This agreement reflects our shared commitment to removing barriers for patients and advancing earlier detection, when treatment is most effective.' Cologuard Plus, which launched in March 2025, has received FDA approval, Medicare coverage, and inclusion in the U.S. Preventive Services Task Force guidelines. About the Cologuard ® and Cologuard Plus ™ tests Developed in collaboration with Mayo Clinic, the Cologuard ® and Cologuard Plus ™ tests are first-line, noninvasive colorectal cancer (CRC) screening options for adults aged 45 or older who are at average risk for the disease. The Cologuard test revolutionized CRC screening by detecting specific DNA markers and blood in stool associated with cancer and precancer, allowing patients to complete the collection kit at home without special preparation or time off, and return the kit to the lab for results. It is included in national screening guidelines from the American Cancer Society (2018) and the U.S. Preventive Services Task Force (2021). Since its inception in 2014, Cologuard has been used to screen for more CRC 20 million times. Building on this success, the FDA-approved Cologuard Plus test raises the performance bar even further and features novel biomarkers, improved laboratory processes, and enhanced sample stability. The Cologuard Plus test is expected to reduce false positives by more than 40% compared to the original Cologuard test, helping minimize unnecessary follow-up colonoscopies. Both tests demonstrate Exact Sciences' commitment to improving CRC screening access and outcomes. About Exact Sciences A leading provider of cancer screening and diagnostic tests, Exact Sciences helps patients and health care providers make timely, informed decisions before, during, and after a cancer diagnosis. The company's growing portfolio includes well-established brands such as Cologuard® and Oncotype DX®, along with innovative solutions like Oncodetect™ for molecular residual disease and recurrence monitoring. Exact Sciences continues to invest in a robust pipeline of advanced cancer diagnostics aimed at improving outcomes. For more information, visit follow @ExactSciences on X, or connect on LinkedIn and Facebook. NOTE: Exact Sciences, Cologuard, and Cologuard Plus are trademarks of Exact Sciences Corporation. The Cologuard test and Cologuard Plus test are only available in the U.S. Forward-Looking Statement This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements regarding the development and commercialization of the Cologuard Plus test and the performance characteristics and health care benefits of the Cologuard Plus test in a commercial setting, as well as statements regarding the development and commercialization of Exact Sciences' pipeline tests. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Yahoo
15-07-2025
- Business
- Yahoo
Tempus AI Raises 2025 Financial Outlook: What's Backing It?
Tempus AI TEM expects full-year 2025 revenues of $1.25 billion (up from the previous $1.24 billion guidance), which represents approximately 80% annual growth. The company also expects adjusted EBITDA of $5 million for the full year of 2025, an improvement of approximately $110 million over 2024. Robust First-Quarter Performance: Total sales in the first quarter amounted to $255.7 million, which grew 75.4% year over year. Quarterly gross profit increased 99.8% year over year, reaching $155.2 million. The gains were fueled by lab efficiencies, increased adoption of AI tools like Tempus One and xM and a higher mix of data services. These improvements narrowed down adjusted EBITDA loss to $16.2 million, from $43.9 million a year ago. Strategic Collaborations With AstraZeneca & Pathos: Tempus signed a three-year, $200 million data and modeling license agreement with AstraZeneca (AZN) and Pathos to build a multimodal foundation model in oncology, leveraging more than 300 petabytes of rich multimodal healthcare data that Tempus has built over the past decade. Notably, the deal raised the total remaining contract value to greater than $1 billion as of April-end. Upside in Hereditary Testing: Hereditary testing revenues hit $63.5 million on 23% volume growth, outpacing the first-quarter guidance. This growth was driven by the acquisition of Ambry Genetics, a recognized leader in genetic testing. The company anticipates long-term potential in this business beyond oncology, extending to cardiovascular, Alzheimer's and other genetic predispositions. For full-year 2025, Exact Sciences EXAS anticipates total revenues in the range of $3.070-$3.120 billion (previously $3.025-$3.085 billion). The adjusted EBITDA forecast is updated to the $425-$455 million band (up from the earlier range of $410-$440 million). A major catalyst for the guidance hike was the successful launch of Cologuard Plus, the company's next-generation colorectal cancer screening test. The test has already seen rapid adoption, with over 30,000 completed tests. TEM reported first-quarter revenues of $706.8 million, marking a 10.9% year-over-year increase. Adjusted EBITDA surged 61%, while free cash flow reached breakeven, an improvement of $120 million from the prior year. These results gave management the confidence to raise its full-year outlook. Exelixis EXEL raised its full-year 2025 financial guidance following strong first-quarter results, driven by higher demand for CABOMETYX and the recent U.S. FDA approval for its use in treating advanced neuroendocrine tumors (NET). The company expects total revenues in the range of $2.25-$2.35 billion (up from the earlier guidance range of $2.15-$2.25 billion). A major factor behind this upward revision was the FDA approval in March 2025 of CABOMETYX for the treatment of advanced pancreatic and extra-pancreatic NET, making it the first and only systemic treatment approved for previously treated NET regardless of tumor site or grade. Additionally, TEM is optimistic about several upcoming clinical milestones in the second half of the year, including pivotal trial readouts for its next-generation therapy zanzalintinib in colorectal and non-clear cell renal cancers. These developments reinforce Exelixis' strategy to expand its oncology portfolio and transition into a multi-franchise cancer company. In the past year, Tempus AI shares have surged 58.6%, outperforming the industry's 16.8% growth and the S&P 500 composite's 11% improvement. Image Source: Zacks Investment Research TEM currently trades at a forward 12-month Price-to-Sales (P/S) of 7.09X compared to the industry average of 5.82X. Image Source: Zacks Investment Research Earnings estimates for Tempus AI in 2025 and 2026 are showing a mixed picture. Image Source: Zacks Investment Research TEM stock currently carries a Zacks Rank #4 (Sell). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Exelixis, Inc. (EXEL) : Free Stock Analysis Report Exact Sciences Corporation (EXAS) : Free Stock Analysis Report Tempus AI, Inc. (TEM) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
16-05-2025
- Business
- Yahoo
EXAS Q1 Earnings Call: Outperformance Driven by Commercial Execution, New Products, and Margin Expansion
Diagnostic company Exact Sciences Corporation (NASDAQ:EXAS) announced better-than-expected revenue in Q1 CY2025, with sales up 10.9% year on year to $706.8 million. The company's full-year revenue guidance of $3.1 billion at the midpoint came in 1.3% above analysts' estimates. Its non-GAAP loss of $0.21 per share was significantly below analysts' consensus estimates. Is now the time to buy EXAS? Find out in our full research report (it's free). Revenue: $706.8 million vs analyst estimates of $688.5 million (10.9% year-on-year growth, 2.7% beat) Adjusted EPS: -$0.21 vs analyst estimates of -$0.10 (significant miss) Adjusted EBITDA: $63.26 million vs analyst estimates of $59.87 million (8.9% margin, 5.7% beat) The company lifted its revenue guidance for the full year to $3.1 billion at the midpoint from $3.06 billion, a 1.3% increase EBITDA guidance for the full year is $440 million at the midpoint, above analyst estimates of $422.9 million Operating Margin: -13.6%, up from -16.7% in the same quarter last year Free Cash Flow was -$365,000 compared to -$120 million in the same quarter last year Constant Currency Revenue rose 11% year on year (5.8% in the same quarter last year) Market Capitalization: $10.6 billion Exact Sciences began 2025 with notable momentum, attributing Q1 results to improved commercial execution and the launch of new products. Management emphasized that changes made to the sales organization, including territory realignment and expanded field engagement, led to a 30% increase in customer interactions. CEO Kevin Conroy cited early success with the launch of Cologuard Plus and continued growth in the company's rescreen and care gap programs as key drivers of revenue for the quarter. Looking ahead, management lifted full-year revenue guidance and highlighted the expected impact of new products and operational efficiency initiatives. CFO Aaron Bloomer said the company expects 'continued leverage across the P&L,' with gross margin improvements and cost optimization actions underway. Management believes the recent launches and increased provider engagement will support both top-line growth and improving profitability throughout the year. Management identified several drivers of Q1 performance, including new product launches, enhanced commercial strategy, and operational improvements. Early signs of adoption for Cologuard Plus and increased engagement with healthcare providers contributed meaningfully to results. Commercial execution enhancements: The expansion and realignment of the sales force, along with targeted provider outreach, led to a 30% increase in provider engagement and higher sales productivity. Management stated that rep productivity was up about 10% and that three out of four new ordering providers were engaged within two weeks. Cologuard Plus launch: The company launched Cologuard Plus, its next-generation colorectal cancer screening test, which achieved early Medicare coverage and quality measure inclusion. Over 30,000 tests have already been completed, with ongoing discussions to secure broader payer coverage. Management emphasized the improved accuracy and lower false positive rate compared to the original Cologuard. Growth in recurring revenue streams: The rescreen program now accounts for more than 25% of total revenue, providing a stable and growing source of recurring income. Management noted increasing adherence rates and a growing eligible patient pool. Operational efficiency gains: Cost optimization and productivity initiatives reduced general and administrative expenses as a percentage of revenue by more than 520 basis points. The company also achieved break-even free cash flow, a $120 million year-over-year improvement. Pipeline and product development progress: Beyond Cologuard Plus, the company launched Oncodetect (a molecular residual disease test), continued work on a blood-based colon cancer screening test (with results expected mid-year), and prepared for the late-2025 launch of Cancerguard for multi-cancer screening. Management's outlook for the remainder of 2025 centers on sustained commercial momentum, expanded adoption of new products, and further cost discipline. The company expects these factors to drive high-single-digit to low-double-digit revenue growth and continued margin improvement. Broader adoption of Cologuard Plus: Management anticipates that securing coverage from additional payers and increasing provider awareness will lead to higher test volumes and improved gross margins due to better pricing and lower test costs. Expansion of recurring programs: Growth in the rescreen and care gap programs is expected to provide predictable revenue and higher customer retention, supporting stability even as new products scale. Operational efficiency initiatives: Further cost optimization, particularly in G&A and manufacturing, is expected to enhance profitability. Management also highlighted the risk of near-term cash flow fluctuations as accounts receivable build with new product launches, but expects collection to normalize by year-end. Tycho Peterson (Jefferies): Asked for details on commercial changes driving new customer growth. Management explained that doctor engagement and rep productivity increased, with new providers being contacted within two weeks of first orders. Catherine Schulte (Baird): Inquired about the breakdown of revenue guidance upgrades. CFO Aaron Bloomer attributed improvements to commercial execution, particularly in rescreens and care gap programs, and increased provider engagement. Brandon Couillard (Wells Fargo): Sought clarity on increased sales and marketing spend. Management responded that investments supported new product launches and were leveraged by strong revenue growth, with a goal of maintaining consistent pacing throughout the year. Patrick Donnelly (Citi): Requested updates on the pipeline and timing for the blood-based colon cancer screening test. CEO Kevin Conroy confirmed the company remains on track for a mid-summer top-line data readout. Luke Sergott (Barclays): Asked about gross margin trends with new product launches. Management stated that Cologuard Plus should be accretive to gross margin, as lower test costs and improved pricing offset potential headwinds from simultaneous product lines. In the coming quarters, the StockStory team will be monitoring (1) the pace of payer adoption and provider uptake for Cologuard Plus, (2) the volume growth and adherence rates in recurring rescreen and care gap programs, and (3) the upcoming mid-year release of top-line data from the company's blood-based colon cancer screening trial. Progress in operational efficiency and continued improvement in free cash flow generation will also be important signposts for tracking execution. Exact Sciences currently trades at a forward P/E ratio of 85.4×. Should you load up, cash out, or stay put? The answer lies in our free research report. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. Put yourself in the driver's seat and build a durable portfolio by checking out our Top 6 Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-small-cap company Comfort Systems (+782% five-year return). Find your next big winner with StockStory today. Sign in to access your portfolio
Medscape
15-05-2025
- Health
- Medscape
Lower FIT Cutoffs Could Cut Costs of CRC Screening
Multitarget stool DNA tests — which are becoming more popular in the United States — have shown increased sensitivity over fecal immunochemical tests (FITs) for early colorectal cancer (CRC) screening, however FITs can be more cost-effective, according to the results of a new study. 'Although our study is not and does not claim to be a comprehensive cost-effectiveness analysis, our results indicate there would be much to gain if the current trends of decreasing FIT use rates and increasing [multitarget stool DNA test] use rates in the United States could be reversed,' wrote Hermann Brenner, MD, of Heidelberg University, Heidelberg, Germany, and colleagues. The main argument in favor of multitarget stool DNA test 'has been their higher sensitivity compared with FIT. However, as previously shown, essentially the same sensitivity and specificity could be achieved at no incremental cost by lowering the FIT positivity threshold,' the authors pointed out. In the study, recently published in the Annals of Internal Medicine , researchers compared screening test performance characteristics of a current multitarget stool DNA test (Cologuard, Exact Sciences) and a next-generation multitarget stool DNA test (Cologuard Plus, Exact Sciences) with a current FIT, using data from close to 170 patients. The sensitivity for CRC was 73.8% for FIT vs 92.3% for the current multitarget stool DNA test, and 67.3% vs 93.9% for FIT vs the next generation multitarget stool DNA test. The sensitivity for any advanced neoplasia was 27.7% vs 46.4% for FIT vs the current multitarget test, and 25.2% vs 45.6% for FIT vs the next generation multitarget test. However, specificities for no advanced neoplasia were higher for FIT at 94.9% and 94.8% compared with 86.6% for the current multitarget test and 90.6% for the next generation test. The researchers assumed a 60% uptake of colonoscopy after a positive result. Overall, the screening costs for each case of advanced neoplasia or early detected CRC were 7-9 times higher for the multitarget stool DNA tests than FIT-based screening tests, they reported. The costs per each additional early CRC case were more than $700,000 for both multitarget tests compared with FIT costs, they noted. The findings are limited by the observational design, but the results suggest value in the increased use of FIT if the positivity threshold was reduced, the researchers stated. 'The FIT cutoffs used in different countries vary widely, and the current practice in the United States that hinders use of quantitative information from FITs and flexibility in defining the positivity threshold should be reconsidered,' they concluded. Follow-up Is Essential to FIT Success The invasiveness of CRC screening tests remains a significant impediment to screening, said David A. Johnson, MD, professor of medicine and chief of Gastroenterology at Eastern Virginia School of Medicine, Norfolk, Virginia, in an interview. Stool-based testing can be done at home 'without the encumberments related to colonoscopy,' said Johnson, who was not involved in the study. However, stool-based testing, in particular FIT, is much less effective in detection of precancerous type polyps, and more of a colon cancer detection test. The goal of screening is cancer prevention rather than simply detection, but these tests are better than no screening, he added. The current study findings were not surprising, as the cost effectiveness of FIT in particular has been previously reported, albeit for the detection of CRC rather than precancerous polyps, Johnson told Medscape Medical News . As for the effectiveness, 'disparities for sensitivity trade off with specificity,' he said. This would mean earlier detection of lesions, as opposed to over-testing for lesions that are not really there. 'FIT testing has been extremely effective when done in well-directed programmatic and systematic testing,' Johnson told Medscape Medical News . 'Following up on noncompliance as well as colonoscopy for positive tests is critical to optimize outcomes for this approach or run the risks for adverse outcomes,' he said. The current study was limited by the potential impact of age and comorbidities on sensitivity testing, he noted. 'The assumptions for this present study would be subject to real world testing, which also might be subject to the demographic locations and insurance related factors for systematic testing and comprehensive follow-up.'
