Latest news with #Cologuard
Business Wire
22-05-2025
- Health
- Business Wire
Exact Sciences Highlights Innovations in Early Cancer Detection and Precision Oncology at ASCO 2025
MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced it will present ten abstracts at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30–June 3, 2025, in Chicago, Ill. Presentations include new data on the Oncodetect™ molecular residual disease (MRD) test, multi-cancer early detection (MCED) testing, the Oncotype DX Breast Recurrence Score® test, and the Cologuard® test that underscore Exact Sciences' expanding portfolio and commitment to advancing care through scientific excellence. 'The data Exact Sciences will present at ASCO 2025 reflect the scientific rigor and clinical significance of our expanding portfolio and pipeline,' said Dr. Rick Baehner, MD, chief medical officer, Precision Oncology at Exact Sciences. 'From MRD to MCED to CRC screening, we are advancing evidence-based innovations that help empower providers and deliver crucial answers to patients. Every study, partnership, and data point move us closer to a future where cancer is detected earlier and treated with greater precision.' Real-world evidence supporting the Cologuard test continues to grow, with ongoing research into repeat screening. New data from prominent experts and research groups reinforce the Oncotype DX® test as a trusted, evidence-backed tool, further affirming its role as the standard of care for predicting chemotherapy benefit for breast cancer patients. Building on more than a decade of experience with Cologuard and 20 years of leadership with the Oncotype DX test, Exact Sciences continues to advance the future of precision oncology and multi-cancer screening. New Data and Continuous Evidence Generation Underscore the Oncodetect Test's Power to Detect Cancer Recurrence. Data from the Beta-CORRECT study further strengthens the clinical foundation of the Oncodetect test, confirming its role in helping guide treatment decisions and surveillance strategies for patients with stage II–IV colorectal cancer1. Expanding on this evidence to multiple solid tumor types, Exact Sciences and Flatiron Health continue enrollment in a multi-year, prospective study evaluating how MRD testing can improve cancer monitoring and treatment decisions in community care settings. New Data Support Promise of MCED as Exact Sciences Prepares for LDT Launch. A modeling study found annual MCED testing could reduce late-stage cancer incidence by more than 40% and mortality by up to 18% in high-risk groups2. Additionally, the Falcon registry, a large, prospective real-world study of Exact Sciences' MCED test, will track 25,000 participants against a 50,000-person standard-care cohort to assess adoption, outcomes, and patient experience. These findings come as Exact Sciences prepares to launch Cancerguard™ EX, its MCED lab-developed test (LDT), in the second half of the year, marking a significant step in expanding access to earlier cancer detection. Exact Sciences abstracts at ASCO include: Precision Oncology The Association of Circulating Tumor DNA (ctDNA) with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT Study Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 3590 Molecular Residual Disease (MRD) in Solid Tumors Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: TPS3186 Enhancing Recurrence Detection in Stage III Colorectal Cancer Patients Through Molecular Residual Disease Test-guided Surveillance: A Modeling Study Abstract number: e15600 Patient outcomes in WSG-ADAPT according to NATALEE and MonarchE risk criteria Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 601 Screening Adherence to repeat screening for colorectal cancer using the multi-target stool DNA test: Real-world analysis of patients from Federally Qualified Health Centers Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 3630 A decade of progress: Trends in 5-year survival across 17 cancer types Abstract number: e23262 The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT Abstract number: 10542 Falcon – Exact Sciences' multi-cancer early detection (MCED) real-world evidence (RWE) registry Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT Abstract number: TPS11189 Evaluation of plasma methylated DNA markers for detection HPV-positive oropharyngeal squamous cell carcinoma: a case control study Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 6057 Feasibility of vaginal tampons versus vaginal swabs in the collection of vaginal fluid for endometrial cancer testing Abstract number: e17617 References Hashimoto et al. The association of ctDNA with recurrence in patients with stage II-IV colorectal cancer: The β-CORRECT study. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. Chhatwal, J., Xiao, J., ElHabr, A., Tyson, C., Cao, X., Raoof, S., Fendrick, A. M., Ozbay, A. B., Limburg, P., Beer, T. M., Deshmukh, A., & Briggs, A. (2025). The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences helps give patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype DX® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. NOTE: Oncotype DX Breast Recurrence Score and Oncodetect are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences, Cologuard, and Cancerguard are trademarks of Exact Sciences. 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 performance characteristics and health care benefits of the Cologuard, Oncotype DX Breast Recurrence Score, Oncodetect, and Cancerguard EX tests 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
20-05-2025
- Business
- Yahoo
Exact Sciences Corporation (EXAS) Slid on Fear of Competition
Baron Funds, an investment management company, released its 'Baron Discovery Fund' first quarter 2025 investor letter. A copy of the letter can be downloaded here. In the first quarter, the fund was down 6.17% (Institutional Shares), outperforming the -11.12% return for the Russell 2000 Growth Index. The market began strong in February but faded due to Trump's serious tariff enactment, which the market perceives as inflationary and slowing economic growth. The decline accelerated after April 2nd, causing fears of a trade war and global recession. In addition, please check the fund's top five holdings to know its best picks in 2025. In its first-quarter 2025 investor letter, Baron Discovery Fund highlighted stocks such as Exact Sciences Corporation (NASDAQ:EXAS). Exact Sciences Corporation (NASDAQ:EXAS) provides cancer screening and diagnostic test products. The one-month return of Exact Sciences Corporation (NASDAQ:EXAS) was 28.97%, and its shares gained 6.39% of their value over the last 52 weeks. On May 19, 2025, Exact Sciences Corporation (NASDAQ:EXAS) stock closed at $56.94 per share with a market capitalization of $10.741 billion. Baron Discovery Fund stated the following regarding Exact Sciences Corporation (NASDAQ:EXAS) in its Q1 2025 investor letter: "Exact Sciences Corporation (NASDAQ:EXAS) is a cancer diagnostics company. Its flagship product is Cologuard, a stool-based screening test for colorectal cancer (CRC). Shares detracted from performance in the quarter due to fears of competitive blood-based CRC tests which may launch in 2025. While these tests cost more than Cologuard, they are somewhat more convenient for patients. However, blood-based tests do not have the same level of pre-cancer sensitivity as Cologuard, and Cologuard is significantly better at detecting pre-cancerous growths called Advanced Adenoma. Moreover, Exact Sciences is developing its own blood-based tests that we anticipate will be as accurate as competitor tests but will cost significantly less than those tests as it uses a different type of analytics to get its results. So, either way, we believe Exact Sciences will win. It also has a huge channel presence in CRC which will enable it to be successful in both fecal and blood-based CRC testing. In addition, with 60 million Americans not receiving any CRC screening at all, there is ample opportunity for multiple players to win." A research team in a laboratory discussing the results of a lab screening test for biomarkers. Exact Sciences Corporation (NASDAQ:EXAS) is not on our list of 30 Most Popular Stocks Among Hedge Funds. As per our database, 49 hedge fund portfolios held Exact Sciences Corporation (NASDAQ:EXAS) at the end of the fourth quarter compared to 41 in the third quarter. Exact Sciences Corporation's (NASDAQ:EXAS) first quarter revenue experienced 11% rise on reported and core basis exceeding the mid pint of guidance over $19 million. While we acknowledge the potential of Exact Sciences Corporation (NASDAQ:EXAS) as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is as promising as NVIDIA but that trades at less than 5 times its earnings, check out our report about the undervalued AI stock set for massive gains. In another article, we covered Exact Sciences Corporation (NASDAQ:EXAS) and shared the list of high P/E stocks that Insiders are buying. In addition, please check out our hedge fund investor letters Q1 2025 page for more investor letters from hedge funds and other leading investors. READ NEXT: Michael Burry Is Selling These Stocks and A New Dawn Is Coming to US Stocks. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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.'
New York Post
09-05-2025
- Health
- New York Post
FDA approves Teal Wand — first at-home test to screen for cervical cancer
The Food and Drug Administration has approved the first at-home test for cervical cancer screening, its maker Teal Health said on Friday, offering an alternative to Pap smears that need to be undertaken at a doctor's office. Pap smear tests have significantly reduced cancer incidence from when they were first introduced 80 years ago. But they can be uncomfortable due to the requirement for an in-clinic exam. Teal Health said the FDA's decision was based on a study in more than 600 women that showed self-collected samples using its test had the same performance as clinician-collected samples. 3 Regulators approved the first at-home test for cervical cancer screening, its maker Teal Health said, offering an alternative to Pap smears that need to be undertaken at a doctor's office. Teal Health/AFP via Getty Images The approval is 'not just about an innovative new product, it's about finally giving women an option that makes sense for their lives — something that can be done quickly and comfortably at home,' said Teal's co-founder and CEO Kara Egan. Each year in the US, about 11,500 new cases of cervical cancer are diagnosed and about 4,000 women die of this, according to the Centers for Disease Control and Prevention. The startup's test, Teal Wand, detects human papillomavirus (HPV), which is responsible for nearly all cervical cancers, similar to Roche's cobas HPV test. But Teal Wand allows women to collect samples from home and send it to a certified lab for testing, while Roche's test is approved for use in the clinic. Teal Health did not disclose the test's price, but said it was working with major insurance providers for coverage and flexible payment options. 3 Teal Wand allows women to collect samples from home and send it to a certified lab for testing. Teal Health/AFP via Getty Images 3 Teal Health said the FDA's decision was based on a study in more than 600 women that showed self-collected samples using its test had the same performance as clinician-collected samples. AP Egan pointed to another at-home test called Cologuard, made by Exact Sciences, to detect colon cancer. 'So Cologuard (is) fully covered by most insurance, but also, if you have to pay out pocket, it's around $600. We plan to be less than that,' she told Reuters. Teal Health plans to begin rolling out the kits in June for patients aged 25 to 65 years.
Epoch Times
03-05-2025
- Health
- Epoch Times
Screening Initiative Cuts Down Colorectal Cancer Rates, Deaths by 50 Percent
Offering patients options to test for colorectal cancer may be a good strategy, according to the results of a study by Kaiser Permanente researchers presented at Digestive Disease Week. Investigators in this 20-year population-based study sent at-home kits for fecal immunochemical testing (FIT) along with colonoscopy reminders to patients overdue for colonoscopies. 'If you offer people more than one option for screening—such as colonoscopy or FIT—they're more likely to get screened than if you offer either option by itself,' Dr. Douglas Corley, researcher and gastroenterologist, said in a Understanding FIT FIT tests in particular are a great way to reach patients who live in rural areas, as well as young adults, who are experiencing more incidents of colorectal cancer even as the overall incidence declines, Corley said in an American Medical Association (AMA) 'So there are a lot of positives about it. And that's one of the reasons why the U.S. Preventive Services Task Force kind of equally recommends colonoscopy and FIT for benefit in terms of decreasing the risk of death from colorectal cancer,' he said in the AMA interview. FIT tests are a noninvasive way to determine whether someone has blood in their stool. People with positive tests would then follow up with a colonoscopy. Some providers may also order Cologuard testing, which looks for DNA of cells shed in the stool, for abnormalities typical of cancer. Study Findings Screening rates—via colonoscopy, sigmoidoscopy, or FIT—grew from 37.4 percent in 2000 to 79.8 percent in 2019 across all racial and ethnic groups, according to the researchers. Giving patients more options in the type of colorectal cancer screening they receive—including a FIT test mailed to their home—reduced the number of those who got cancer by a third, reduced the deaths in half, and eliminated nearly all the racial differences in screenings, diagnoses, and death. There was a spike in colorectal cancer diagnoses during the first three years of the study—due to early detection—with overall incidence dropping across the cohort by 30 percent. Related Stories 3/22/2025 2/14/2023 Colorectal cancer deaths decreased by about 50 percent, with the largest reductions seen in black patients who have historically had worse outcomes from colorectal cancer. Deaths among black patients declined from 52.2 per 100,000 to 23.5 per 100,000. Corley said during an online media briefing that the changes were sustained through the duration of the study. 'It's really remarkable that some of these large differences by mortality in race and ethnicity that we saw two decades ago and which we see throughout the United States are now similar,' he said. These results demonstrate that offering more options to everyone levels the playing field for preventive care, he added. Study Strengths The size and scope of the study indicate that similar findings could be expected if it were reproduced, Corley said. The study also had diverse participants who reflected the population at large, and it followed them for two decades. 'This model could be applied to other preventable conditions with effective interventions such as hypertension and kidney disease,' said Corley. Offering people choices—including a test they could do without leaving their house— is one way to reach more people and simplify the screening process. He added that colonoscopies aren't always convenient, as they may need to take a day off of work, and drinking the bowel prep can cause uncomfortable bowel movements. Corley noted that not everyone wants the risks involved with colonoscopies, which include tears, bleeding, infection, and reaction to sedatives. One weakness of the study was that it didn't look at root cause issues like diet and environment that could be contributing to cause or death, he said, adding that exactly how these factors contribute is still uncertain. However, Corley noted that screenings help everyone regardless of root cause, and the study proved that screenings do give patients a better chance to prevent cancer—and survive if they do get it. 'I think that was one of the more remarkable things. When you take something that is the second largest cause of cancer deaths and in a short period of time you cut that in half.'
