COMPANY:

Exact Sciences Corp

"Exact Sciences Corp...announced the company will present modeling data evaluating the simulated benefit and burden of established CRC screening strategies, including the Cologuard Plus test during the American College of Gastroenterology (ACG) Annual Meeting. ACG takes place October 25-30, 2024, in Philadelphia, Pennsylvania. Exact Sciences will also present new data on improving adherence to help close the gap in CRC screening. ACG abstracts are available on the meeting website....Researchers used a validated simulation model to assess the benefit to burden ratio of the Cologuard Plus test and other established and emerging CRC screening options. Benefit was defined as life-years gained and burden as the lifetime number of colonoscopies."

"Exact Sciences Corp...announced the U.S. Food and Drug Administration (FDA) approved the Cologuard Plus test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC). FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening."

"Exact Sciences Corp...today announced performance data for its blood-based colorectal cancer (CRC) screening test. Results show sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy...Results of this study show the potential of a novel, highly discriminate blood-based panel of methylated DNA markers and an impactful, new marker class to detect advanced precancerous lesions and cancers at an attractive cost profile. The company will implement the innovative marker class on a new testing platform and complete additional analytical studies to support an FDA submission."

"Exact Sciences...today announced that the first patient has joined its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence (RWE) study at Baylor Scott & White, the primary study site and largest not-for-profit health system in Texas."

"Exact Sciences Corp...today describing the projected impact of the Cologuard test on patients, health care professionals, and the U.S. health care system since its FDA approval 10 years ago."

"TwinStrand Biosciences today announced an agreement with Exact Sciences...to exclusively license its patent estate in the cell free nucleic acid sequencing space, including its patent portfolios licensed from the University of Washington and the University of Texas Southwestern. The license is related to TwinStrand Duplex Sequencing error-correction technology, which increases the accuracy of next-generation sequencing by as much as 10,000 times, allowing the detection of ultra-low frequency mutations that would otherwise be hidden by technical noise inherent to the sequencing process. This agreement provides Exact Sciences the ability to use, commercialize, and sublicense the intellectual property acquired under the license....'This agreement with TwinStrand represents a significant advancement in Exact Sciences' ability to pioneer new frontiers in early cancer detection and precision oncology'."

"Exact Sciences...awarded a total of $1.5 million to 28 organizations through its Funding Opportunities for CRC Screening Uptake Strategies (FOCUS) Program. Grant recipients are committed to improving colorectal cancer (CRC) screening rates and making health care more accessible, with a focus on medically underserved populations."

"Exact Sciences, announced today that it awarded a total of $1.5 million to 28 organizations through its Funding Opportunities for CRC Screening Uptake Strategies (FOCUS) Program. Grant recipients are committed to improving colorectal cancer (CRC) screening rates and making health care more accessible, with a focus on medically underserved populations....Exact Sciences’ FOCUS Program provides grant funding to community organizations, health foundations, public health organizations, and advocacy groups working to increase access to CRC screening and awareness." "

"Geneoscopy announced Monday that it has filed a lawsuit against Exact Sciences in federal court in Delaware in relation to a patent that is central to both companies' colorectal cancer screening tests."

"This study analyzed Recurrence Score gene axis scores and their associations with outcomes to understand the differences in underlying tumor biology among different racial and ethnic groups. Recurrence Score gene axis scores differed by race/ethnicity, with Non-Hispanic Black patients exhibiting higher proliferation axis scores than other groups. This could partially explain the poorer outcomes observed in this population in the RxPONDER trial....Real-world evidence from the SEER registries in over 145,000 patients with breast cancer confirms that the Oncotype DX Breast Recurrence Score test is prognostic of breast cancer-specific survival across all racial and ethnic groups and predictive of chemotherapy benefit across most groups."

"Exact Sciences Corp...will present 10 abstracts highlighting the breadth and depth of the company’s screening and diagnostic portfolio at the American Society of Clinical Oncology® (ASCO®) Annual Meeting, taking place May 31 – June 4, 2024, in Chicago, Ill. Presentations will include new data confirming both the predictive and prognostic value of the Oncotype DX Breast Recurrence Score® test in racially and ethnically diverse patients. Exact Sciences will also present data on its approach to multi-cancer early detection (MCED) across multiple tumor types, plus additional real-world evidence showing optimized screening adherence strategies for the Cologuard® test as well as high adherence rates for repeat screenings."

"Exact Sciences Corp...announced that a District Court judge denied in part Geneoscopy’s (defendant) motion to dismiss a patent infringement lawsuit filed by Exact Sciences (plaintiff) in the United States District Court for the District of Delaware. This ruling paves the way for Exact Sciences to seek relief for Geneoscopy’s future infringement and false advertising."

"The UK National Institute for Health and Care Excellence (NICE)...recommended three prognostic gene expression tests as tools for guiding adjuvant chemotherapy treatment decisions in an expanded population of early breast cancer patients...In a final guidance, NICE said Myriad Genetics' EndoPredict (which is being sold to Eurobio), Veracyte's Prosigna, and Exact Sciences' Oncotype DX can be used within the National Health Service (NHS) to guide adjuvant treatment for postmenopausal women or men with estrogen receptor-positive, HER2-negative early breast cancer and one to three positive lymph nodes."

"Exact Sciences Corp...announced today the company will present six abstracts on strategies and advancements for improving colorectal cancer screening rates and outcomes during Digestive Disease Week (DDW) 2024, May 18-21 in Washington, D.C. This includes data on Cologuard, the best-in-class non-invasive screening test for colorectal cancer in patients 45 and older at average risk, and the next-generation Cologuard test in development, Cologuard Plus."

"Exact Sciences Corp...will present late-breaking data from the first analysis of the ASCEND-2 study demonstrating the compelling performance of its investigational multi-biomarker class, multi-cancer early detection (MCED) blood test...data will be presented at the American Association for Cancer Research® (AACR) Annual Meeting 2024, April 5-10 in San Diego, California."

"Exact Sciences...announced the launch of an initiative with Mayo Clinic to provide comprehensive genomic profiling and hereditary cancer tests to patients. The initiative expands the collection of data accessible to Mayo Clinic researchers and clinicians to advance cancer research and patient care."

"Exact Sciences Corp...in collaboration with Mayo Clinic Comprehensive Cancer Center, reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard® Esophagus test that is currently in development for the detection of esophageal adenocarcinoma (EAC) and its precursors, including Barrett’s esophagus (BE).1,2 Findings from the test’s algorithm training and testing were recently published in the Clinical Gastroenterology and Hepatology journal."

P=Obs | N=23,494 | BLUE-C (NCT04144751) | Sponsor: Exact Sciences Corporation | "Exact Sciences...announced online publication of the BLUE-C study results in The New England Journal of Medicine....Cologuard Plus met all BLUE-C study endpoints, demonstrating 94% sensitivity for CRC at 91% specificity including non-advanced findings, and 93% specificity including no findings. Specificity was even better in younger age groups, at 96% in 45-54 year olds. Cologuard Plus will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test. Results from BLUE-C also show Cologuard Plus significantly outperformed an independent FIT for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity."

"Exact Sciences Corp...announced the launch of the Riskguard™ hereditary cancer test in the United States. The Riskguard test provides an individualized patient report that includes gene specific and familial risks using a simple blood or saliva sample for 10 common cancers, including colorectal, breast, prostate, skin, ovarian, endometrial, pancreatic, gastric, kidney and endocrine."

"Exact Sciences Corp...present new data and study results across its Precision Oncology and hereditary cancer platforms at the 2023 annual San Antonio Breast Cancer Symposium (SABCS)."

"Exact Sciences Corp...announced that it has filed a lawsuit against Geneoscopy, Inc. in the United States District Court for the District of Delaware."

"Exact Sciences Corp...announced late-breaking data from the pivotal BLUE-C trial showing the next-generation Cologuard test met all study endpoints, demonstrating 94 percent sensitivity for colorectal cancer (CRC) at 91% specificity, during the American College of Gastroenterology (ACG) Annual Meeting 2023."

"Exact Sciences Corp...announced it will present new data supporting the company's research in early cancer detection, genomic testing, and treatment guidance at the 2023 European Society for Medical Oncology (ESMO) Congress, October 20-24, in Madrid, Spain."

"Exact Sciences Corp...announced the company will present late-breaking data on next-generation Cologuard^® from the BLUE-C pivotal trial during the American College of Gastroenterology (ACG) Annual Meeting, taking place October 20-25, 2023, in Vancouver, Canada."

"Cancer test maker Genomic Health, now a wholly owned subsidiary of Exact Sciences, has agreed to pay $32.5 million to resolve allegations that it violated the False Claims Act by engaging in a nationwide scheme to improperly bill Medicare for certain laboratory tests used to diagnose and treat cancer patients."

"Agilent Technologies...and Exact Sciences Corp...announced they have entered into a definitive agreement for the sale of Resolution Bioscience to Exact Sciences. Financial terms of the agreement were not disclosed and are not material to either party."

"Exact Sciences Corp...announced that the National Cancer Institute (NCI) has selected the company's testing laboratory in Phoenix, AZ to participate in the ComboMATCH clinical trials, one of the NCI-funded precision medicine initiatives. As a ComboMATCH-designated lab, Exact Sciences will use its new OncoExTra test to analyze tumor tissue and paired normal blood samples from patient participants and uncover the specific abnormalities in a patient's tumor that may be most effective to treat."

"Exact Sciences Corp...announced separate collaborations with two renowned healthcare organizations at the forefront of cancer research. The agreements aim to improve patient care by increasing access to genomic information. Combining cutting-edge technologies with expertise from thought leaders at Broad Institute of MIT and Harvard and Baylor Scott & White, Exact Sciences will provide smarter answers before diagnosis and throughout cancer treatment."

"Exact Sciences Corp...announced positive top-line results from the pivotal BLUE-C study. The results show that next-generation Cologuard met all study endpoints and improved every top-line metric, including a 30 percent lower false positive rate, when compared to DeeP-C, the FDA registrational trial for Cologuard."

"Exact Sciences Corp...announced today that it will present 15 abstracts at the American Society of Clinical Oncology^® (ASCO^®) Annual Meeting 2023, June 2-6, in Chicago, Illinois. Presentations include new data confirming Exact Sciences' approach to multi-cancer early detection (MCED), real-world outcomes using the Oncotype DX Breast Recurrence Score^®, and modeling comparisons between Cologuard^® and potential blood-based screening tests for colorectal cancer....In addition, Exact Sciences will present a new, long-term Surveillance, Epidemiology, and End Results (SEER) analysis showing that the Oncotype DX Breast Recurrence Score® test is prognostic for breast cancer-specific mortality (BCSM) in patients with invasive ductal carcinoma (IDC) and invasive lobular breast cancer (ILC)."

"Exact Sciences...announced today that it awarded $1.1 million to 18 organizations through its Funding Opportunities for CRC Screening Uptake Strategies (FOCUS) Program. Grant recipients are committed to improving uptake of colorectal cancer (CRC) screening and supporting affordable pathways to follow-up care for people who are medically underserved."

"Exact Sciences Corp...presented new data supporting the company's research and innovation in colorectal cancer (CRC) during Digestive Disease Week^® (DDW) 2023, May 6-9 in Chicago, Illinois. Among nine abstracts presented at the meeting were results from three modeling studies estimating health outcomes of stool- and blood-based CRC screening strategies in people at average risk of CRC....Results showed that estimated LYG from average-risk screening were more strongly associated with adenoma detection than early-stage CRC detection."

"Exact Sciences Corp...announced that it will present new data highlighting the company's novel technology and approaches to early cancer detection at the American Association for Cancer Research (AACR) Annual Meeting 2023, April 14-19, in Orlando, Florida."

"Informatics and clinical decision support firm VieCure said Monday that it has entered a strategic collaboration with Exact Sciences aimed at improving access to precision oncology diagnostics for US patients and community oncologists...Under the agreement, Denver-based VieCure will integrate Exact Sciences’ portfolio of diagnostic tests —beginning with the Oncotype DX breast cancer recurrence test — for interpretation via its clinical oncology care management platform."

"Exact Sciences Corp...announced the launch of the OncoExTra™ therapy selection test in the United States. OncoExTra is a next-generation sequencing (NGS), comprehensive DNA and RNA based genomic test providing doctors and their patients a complete molecular picture of the patient's cancer. The test provides reliable and actionable results personalized to each patient."

"Exact Sciences Corp...supports recent policy changes that help increase access to recommended non-invasive colorectal cancer screening tests. These policy changes require Medicare and most commercial insurers to pay for colonoscopy after a positive Cologuard® test without cost to the patient. For most patients, these financial protections take effect starting January 1, 2023."

"Exact Sciences Corp...shared initial clinical validation data for its breast cancer radiation signature, Profile for the Omission of Local Adjuvant Radiotherapy (POLAR), at the 2022 San Antonio Breast Cancer Symposium (SABCS). The meta-analysis of three independent, randomized clinical trials identified which early-stage breast cancer patients benefited from radiotherapy after breast-conserving surgery."

"Exact Sciences Corp...announced that new data presentations supporting the clinical value of its Precision Oncology portfolio will be shared in ten abstracts and three presentations at the 2022 San Antonio Breast Cancer Symposium (SABCS). The data presented highlight the Oncotype DX Breast Recurrence Score test, Oncomap ExTra test, a new investigational test to predict radiation therapy benefit, and an initial look at Exact Sciences' tumor-naive minimal residual disease (MRD) approach."

"Genialis...is presenting new data and results this week from its biomarker discovery platform, ResponderIDTM. At the Society for Immunotherapy of Cancer (SITC) annual meeting, Genialis Chief Discovery Officer Luka Ausec, Ph.D. is co-presenting a poster with Exact Sciences and OncXerna Therapeutics titled, 'Xerna tumor microenvironment subtypes as a biomarker in lung cancer patients'....The poster explores the relationship between Xerna TME subtypes and DNA-based (e.g. gene variants) biomarkers in NSCLC."

"Exact Sciences Corp...today announced the company will present new data supporting the positive impact of Cologuard® as a colorectal cancer screening tool during the American College of Gastroenterology (ACG) Annual Meeting, being held October 21-26, 2022."

"Exact Sciences Corp...today announced data from a multi-cancer early detection (MCED) biomarker validation study was presented at the European Society for Medical Oncology (ESMO) Congress. The study rigorously assessed the performance of four distinct biomarker classes found in the blood and known to signal the presence of cancer regardless of its location in the body."

"MDxHealth...announced it has entered into an asset purchase agreement with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation ('Exact Sciences'), to acquire the Oncotype DX® GPS (Genomic Prostate Score®) test from Exact Sciences along with most of its team of urology sales and marketing professionals. This addition further solidifies the Company’s leadership in the precision diagnostics urology market."