COMPANY:

Exact Sciences Corp

"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."

"The PGA TOUR Champions, the Tucson Conquistadores, the First Tee Tucson, and Exact Sciences, the maker of Cologuard®, announced today that the Madison, Wisconsin-based company will now be the presenting sponsor of the Cologuard Classic. The announcement also extends Cologuard’s title sponsorship through the 2027 season. The 2023 Cologuard Classic by Exact Sciences will take place at the Omni Tucson National Resort from February 27th through March 5th and will have a $2.2 million purse, with $330,000 to the winner."

"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."

"Together, Exact Sciences and WSG plan to conduct a prospective, multicenter validation study in hormone receptor (HR)-positive, HER2-negative early breast cancer patients. The study is intended to demonstrate the ability of Exact Sciences' tumor-informed ctDNA liquid biopsy test to detect minimal residual disease (MRD) and to collect important long-term follow-up and outcome data. The combined analysis, called ADAPT Triad, is expected to include data from approximately 3,000 German patients enrolled in two ongoing WSG ADAPT trials and one WSG registry study."

"Ultima Genomics, Inc. and Exact Sciences Corporation...have entered a long-term supply agreement for Ultima's next-generation sequencing (NGS) technologies. Under the terms of the supply agreement, Ultima Genomics will provide access to its NGS products, which are based on a new architecture designed to enable sequencing at a fraction of the cost of other commercially available technologies. The companies also plan to develop one or more of Exact Sciences' advanced cancer diagnostic tests using Ultima's sequencing technology."

"Exact Sciences Corp...announced new data supporting its cancer tests and treatment guidance tools will be showcased in nine poster presentations and five e-abstracts at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 3-7 in Chicago, Illinois...The analyses support use of Oncomap™ and Oncomap™ ExTra, comprehensive genomic profiling tests formerly known as the Oncotype Map™ Pan-Cancer Tissue and GEM ExTra® tests, respectively, to inform targeted therapy selection and clinical trial options for patients with advanced solid tumors."

"Exact Sciences Corp...announced the American Urological Association (AUA) updated their guidelines to include genomic assays, such as the Oncotype DX Genomic Prostate Score® (GPS™) test, when treating men with localized prostate cancer. The 2022 guidelines now state that clinicians may selectively use tissue-based genomic biomarkers when added risk-stratification may alter clinical decision-making....This is the first in-person AUA meeting where Exact Sciences will feature its full Oncotype® portfolio of urologic genomic assays, including the Oncotype DX® GPS test for localized prostate cancer; the Oncotype MAP™ Pan-Cancer Tissue test for solid tumors, including advanced prostate cancer; and the Oncotype DX AR-V7 Nucleus Detect® test for metastatic castration-resistant prostate cancer."

"Exact Sciences Corp...announced that recommended use of its Oncotype DX Breast Recurrence Score® test in early-stage breast cancer patients has been expanded by the American Society of Clinical Oncology (ASCO) in its 2022 Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer guideline update...The test is now recommended for use in postmenopausal patients with up to three positive axillary lymph nodes and is the only test recommended for use in premenopausal patients with node-negative disease."

"Exact Sciences Corp...announced performance data for a second-generation Cologuard (multi-target stool DNA) test showing overall sensitivity of 95.2% for colorectal cancer (CRC) at specificity of 92.4% for negative samples confirmed by colonoscopy. Subgroup analyses showed 83.3% sensitivity for high-grade dysplasia, the most dangerous precancerous lesions, and 57.2% for all advanced precancerous lesions. These data will be presented January 22 at ASCO GI in a poster titled, 'Second-generation Multi-target Stool DNA Panel Reliably Detects Colorectal Cancer and Advanced Precancerous Lesions'."

"Exact Sciences...announced today it has acquired PreventionGenetics, a genetic testing laboratory, to complement its advanced cancer diagnostics portfolio and support its entrance into hereditary cancer testing (HCT). PreventionGenetics provides the clinical lab, expertise, and foundational technology necessary to accelerate the availability of HCT and help more patients know their germline risk of cancer and other diseases....Under the terms of the agreement, PreventionGenetics received total consideration of $190 million, comprised of 50% in Exact Sciences common stock and 50% in cash."

"Exact Sciences...and OncXerna Therapeutics...announced today they have entered an exclusive license agreement to bring OncXerna's Xerna TME Panel lab services to more U.S. patients. The Xerna TME (tumor microenvironment) Panel is an innovative gene expression score that helps identify patients likely to respond to anti-angiogenic and immunotherapies. The agreement allows Exact Sciences to provide more critical answers to cancer patients and physicians facing difficult therapy selection decisions supporting biopharma partners in patient selection for their therapeutic programs."

"Exact Sciences Corp...announced the presentation of new data at the 2021 San Antonio Breast Cancer Symposium® (SABCS®) supporting the clinical value of the Oncotype DX Breast Recurrence Score test."

"Exact Sciences Corp...announced that data from the Rx for Positive Node, Endocrine Responsive Breast Cancer, or RxPONDER, trial were published in The New England Journal of Medicine. The study, led by the independent SWOG Cancer Research Network and sponsored by the National Cancer Institute (NCI), successfully defined the benefit of chemotherapy in early-stage, node-positive breast cancer patients with Oncotype DX Breast Recurrence Score® results of 0 to 25...In the study, postmenopausal women with 1 to 3 positive nodes and Recurrence Score® results of 0 to 25 showed no benefit from chemotherapy after a median of five years of follow-up, meaning they can potentially avoid negative side effects of the treatment."

"In a Form 8-K filed on Monday with the US Securities and Exchange Commission, Exact Sciences said that Pfizer will no longer promote the company's Cologuard colorectal cancer screening test to healthcare providers. In an email, the company further noted that Pfizer will also no longer sell the test."

"Exact Sciences Corp...announced the publication of results underscoring the importance of adverse pathology as a reliable and critical endpoint for risk-assessment in clinically low-risk prostate cancer patients...The findings strongly support the clinical use of the Oncotype DX Genomic Prostate Score® (GPS™) test, the only commercial genomic test that was specifically developed to improve assessment of a patient's risk of adverse pathology, beyond clinical factors alone, and optimized to perform in biopsy samples."

"Exact Sciences Corp...announced an agreement with Jefferson Health (Jefferson) to conduct research on a new blood-based, multi-cancer earlier detection (MCED) test. This unique effort will engage primary care and specialty providers, care coordinators, and patients from diverse populations across the Jefferson enterprise in research that aims to evaluate MCED test safety and efficacy and help determine how to facilitate the implementation of effective MCED testing in the future."

"Exact Sciences Corp...today shared data from modeling analyses that demonstrate Cologuard (mt-sDNA), with its included patient navigation system, provides a greater reduction in incidence and mortality from colorectal cancer (CRC) compared to annual fecal immunochemical test (FIT), when it included outreach, with or without a mailed annual FIT, using real world adherence rates in a simulated Medicaid population. Cologuard remained cost-effective in all the real-world adherence scenarios modeled. The modeling analyses were consistent with the CISNET Colorectal Working Group models when using 100% adherence rates."

"Exact Sciences Corp...announced today that it has entered into a collaboration agreement with the National Surgical Adjuvant Breast and Bowel Project (NSABP), a cooperative group founded by the National Cancer Institute (NCI). Working together, Exact Sciences and the NSABP plan to conduct a prospective, multicenter validation study with stage II and III colorectal cancer (CRC) patients, demonstrating the ability of Exact Sciences’ ctDNA test to detect MRD. The study, called CORRECT-MRD II, is expected to enroll approximately 750 patients at 35 study sites in the U.S. and Canada and is part of Exact Sciences’ global initiative to generate clinical validation data for its tumor-informed MRD liquid biopsy test."

"Exact Sciences Corp...announced the company will present new data and exhibit its portfolio of prostate cancer genomic tests at its virtual booth, during the American Urological Association’s Annual (AUA 2021) Meeting, being held September 10-13. This is the first AUA meeting where Exact Sciences will feature its full Oncotype® portfolio of urology genomic assays, including the Oncotype DX Genomic Prostate Score® (GPS™) test for localized prostate cancer; the Oncotype MAP™ Pan-Cancer Tissue test for solid tumors, including advanced prostate cancer; and the Oncotype DX AR-V7 Nucleus Detect® test for metastatic castration-resistant prostate cancer."

"Exact Sciences Corp...announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved the Oncotype DX Breast Recurrence Score® Program. The test helps guide chemotherapy treatment recommendations and provides risk of distant recurrence in patients with hormone receptor-positive, HER2-negative early-stage breast cancer with up to three positive lymph nodes. MHLW approval is a critical step in making Oncotype DX® accessible to breast cancer patients in Japan."

"Exact Sciences Corp...announced today that the performance of its Oncoguard™ Liver liquid biopsy test is now published online in the peer-reviewed journal Clinical Gastroenterology and Hepatology (CGH). The test delivers 82% early-stage sensitivity, and an overall 88% sensitivity and 87% specificity for the detection of hepatocellular carcinoma (HCC), the leading form of liver cancer."

"Exact Sciences today announced results from a health economic analysis[i] of the Oncotype DX Breast Recurrence Score® test, accepted at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and published online in the ASCO meeting library. This analysis shows the positive impact of initial results from the RxPONDER trial on the test’s cost-effectiveness in postmenopausal women with one to three positive lymph nodes...The findings showed that chemotherapy can be spared for the majority of postmenopausal women, those with Recurrence Score® results 0-25, increasing expected cost-savings without compromising patient outcomes and resulting in 50% greater cost-savings compared to the pre-RxPONDER scenario. The impact on cost-effectiveness was examined based on the list price for the test in the UK."

"Exact Sciences Corp...today highlights data from one oral and one poster presentation being featured at the 2021 Digestive Disease Week® (DDW®) virtual annual meeting, taking place May 21-23...The data showed that Cologuard® (mt-sDNA) was cost effective and provided the greatest reduction in CRC incidence and mortality versus annual fecal immunochemical test (FIT) and annual fecal occult blood test (FOBT) in a representative Medicare population."

"Exact Sciences Corp...today announced new data on its cancer tests and treatment guidance tools will be showcased in seven presentations and one e-abstract at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually June 4-8."

"The United States Preventive Services Task Force (USPSTF) today released its final colorectal cancer screening recommendation that screening begin at age 45. Exact Sciences'...Cologuard®, referred to as sDNA-FIT, is included as a recommended screening option for all average-risk patients between the ages of 45 and 75...According to this updated recommendation, all average-risk adults age 45 and older should now be screened for colorectal cancer."

"Get Your Rear in Gear - Madison is presented by Promega and Exact Sciences with the support of the Colon Cancer Coalition. This inaugural event is one of nearly 40 held annually across the country planned by local volunteers. Money raised will go to UW Carbone Cancer Center programs aimed at increasing colon cancer screening and early detection."

"Exact Sciences...today announces study results published in Mayo Clinic Proceedings showing that Cologuard (mt-sDNA) is the most cost-effective colorectal cancer (CRC) screening option in the Alaska Native population, as compared to colonoscopy and the fecal immunochemical test (FIT), for a wide range of adherence scenarios. According to the model, Cologuard produced the highest number of quality adjusted life years (QALYs) gained and the largest reduction in CRC incidence."

"Exact Sciences Corp...today announced that it has completed its previously announced acquisition of Ashion Analytics, LLC...With Ashion, we've added a talented team, a CLIA-certified and CAP-accredited lab, deep sequencing capabilities, and one of the most comprehensive genomic cancer tests available on the market today with GEM ExTra®. Exact Sciences and The Translational Genomics Research Institute (TGen) are expanding their multi-year collaboration to further benefit from TGen and City of Hope's expertise in developing better advanced cancer diagnostics and establishing the clinical evidence necessary to support their adoption."

"Exact Sciences today announced that its Oncotype DX Breast Recurrence Score® test has been recognized as the only test that can be used for prediction of chemotherapy benefit in early-stage breast cancer patients with 1-3 positive axillary lymph nodes, including micro metastases, by the National Comprehensive Cancer Network (NCCN) in its updated guidelines for breast cancer. The Oncotype DX® test is now the only test classified as 'preferred' with the highest level of evidence for node-negative and postmenopausal node-positive patients."

"Exact Sciences Corp...today announced that it has entered into an agreement to acquire Ashion Analytics, LLC (Ashion) from The Translational Genomics Research Institute (TGen), an affiliate of City of Hope...This acquisition will build upon the recent license of the TARDIS technology from TGen and strengthen the relationship between the institutions through a planned 10-year research collaboration."

"Exact Sciences Corp…today announced that it has acquired a worldwide exclusive license to the proprietary TARDIS technology from The Translational Genomics Research Institute (TGen), an affiliate of City of Hope. This compelling and technically distinct approach will help expand Exact Sciences' leadership in precision oncology and offers a differentiated patient-specific solution in minimal residual disease testing."

"Exact Sciences Corp…announced that it has completed its previously announced acquisition of Thrive Earlier Detection Corp. (‘Thrive’)…‘Bringing Thrive into the Exact Sciences family marks a giant leap toward blood-based, multi-cancer screening becoming a reality and eventually the standard of care…’"

"Today Stand Up To Cancer^® (SU2C) unveiled a collaborative initiative aimed at improving colorectal cancer screening, early detection and prevention across the United States. The transformative $10 million grant from Exact Sciences, a provider of cancer screening and diagnostic tests, will fund a colorectal cancer 'Dream Team' of researchers, as well as a comprehensive public awareness campaign to increase screenings."

"Biocartis Group NV…today announces that the Company is currently in discussions with Exact Sciences regarding the potential termination of the agreements that the Company had previously entered into with Genomic Health, Inc. (now part of Exact Sciences) in relation to the development of an in vitro diagnostic version of the Oncotype DX Breast Recurrence Score® test."

"Exact Sciences Corp...and Thrive Earlier Detection Corp. ('Thrive'),...announced they have entered into a definitive agreement under which Exact Sciences will acquire Thrive for cash and stock consideration of up to $2.15 billion.The transaction was unanimously approved by both companies' Boards of Directors and is anticipated to close during the first quarter of 2021, subject to regulatory approval and the satisfaction of other conditions...We are proud to take our partnership to the next level by leveraging Exact Sciences' established R&D team and highly accurate testing platform to augment development of CancerSEEK and accelerate its commercialization."