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COMPANY:
Exact Sciences Corp

i
Other names: Resolution Bioscience | Resolution Bioscience, Inc. | Resolution Bioscience Inc | Resolution Bioscience Inc. | Exact Sciences Corporation | Exact Sciences Corp. | Genomic Health, Inc. | Thrive Earlier Detection Corp. | Thrive Earlier Detection Corp | Thrive Earlier Detection Corporation | Thrive Earlier Detection | Ashion Analytics LLC | Ashion Analytics, LLC | Ashion
Related tests:
Evidence

News

6d
The New England Journal of Medicine Publishes Cologuard Plus Test Results from Pivotal BLUE-C Study (Businesswire)
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."
Observational data
19d
Exact Sciences launches Riskguard Hereditary Cancer Test in the United States (Exact Sciences Press Release)
"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."
Launch US
4ms
Exact Sciences presents multiple studies at San Antonio Breast Cancer Symposium supporting optimization and individualization of therapy for breast cancer patients (Exact Sciences Press Release)
"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)."
Clinical data
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Oncotype DX Breast Recurrence Score®Test
4ms
Exact Sciences files patent infringement lawsuit against Geneoscopy (Exact Sciences Press Release)
"Exact Sciences Corp...announced that it has filed a lawsuit against Geneoscopy, Inc. in the United States District Court for the District of Delaware."
Corporate lawsuit • Patent
5ms
Next-Generation Cologuard test demonstrates high sensitivity and specificity in pivotal BLUE-C study, significantly outperforming fecal immunochemical testing (FIT) for cancer and precancer detection (Exact Sciences Press Release)
"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."
Clinical data
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Cologuard®
5ms
Exact Sciences advances early cancer detection and precision oncology programs with data presentations at ESMO 2023 annual congress (Exact Sciences Press Release)
"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."
Clinical data
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Cancerguard™ • OncoExTra™ test
5ms
Exact Sciences to Present Late-Breaking Data from Pivotal BLUE-C Study on Next-Generation Cologuard at ACG 2023 (PRNewswire)
"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."
Late-breaking abstract • Observational data
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Cologuard®
6ms
Genomic Health to pay $32.5M to resolve cancer test false claims allegations by DOJ (Genomeweb)
"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."
Medicare • Corporate lawsuit • Reimbursement
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Oncotype DX Breast Recurrence Score®Test
6ms
Agilent Technologies and Exact Sciences agree to terms of sale for Resolution Bioscience (Agilent Technologies Press Release)
"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."
Licensing / partnership
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OncoExTra™ test
7ms
Exact Sciences lab and Oncoextra test selected by national cancer institute for Combomatch clinical trials (Exact Sciences Press Release)
"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."
Clinical data
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OncoExTra™ test
9ms
Exact Sciences advances innovative cancer technologies and approaches through visionary collaborations (Exact Sciences Press Release)
"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."
Licensing / partnership
9ms
Next-Generation Cologuard test demonstrates 94 percent sensitivity for colorectal cancer at 91 percent specificity, raising the bar in non-invasive screening (Exact Sciences Press Release)
"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."
Clinical
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Cologuard®
10ms
Exact Sciences Presents New Long-Term Patient Outcomes in Multi-Cancer Early Detection and Breast Cancer Recurrence Testing at ASCO 2023 (PRNewswire)
"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)."
Clinical data
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Cologuard® • Oncotype DX Breast Recurrence Score®Test
10ms
Exact Sciences awards grants to 18 organizations focused on increasing colorectal cancer screenings (Exact Sciences Press Release)
"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."
11ms
Exact Sciences Extends Leadership in Colorectal Cancer Screening with New Data Presented at Digestive Disease Week Annual Meeting (PRNewswire)
"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."
Clinical data • Clinical
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Cologuard®
11ms
Exact Sciences presents advancements in cancer detection at American association for cancer research 2023 annual meeting (Exact Sciences Press Release)
"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."
Clinical data
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OncoExTra™ test
1year
VieCure, Exact Sciences partner to ease genomic testing access, interpretation (Genomeweb)
"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."
Licensing / partnership
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Oncotype DX Breast Recurrence Score®Test
1year
Exact Sciences launches OncoExTra™ cancer therapy selection test in the U.S. (Exact Sciences Press Release)
"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."
Launch US
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OncoExTra™ test
1year
Medicare and Insurance policy updates in 2023 will improve cancer screening access by removing patient colonoscopy cost following a positive Cologuard test (Exact Sciences Press Release)
"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."
Medicare • Reimbursement
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Cologuard®
over1year
Exact Sciences presents first time data detailing ability to predict radiation therapy benefit in breast cancer patients (Exact Sciences Press Release)
"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."
Clinical data
over1year
Exact Sciences highlights the impact of precision oncology portfolio on breast cancer treatment with 10 new data presentations at SABCS 2022 (Exact Sciences Press Release)
"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."
Clinical data
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Oncomap™ ExTra test • Oncotype DX Breast Recurrence Score®Test
over1year
Genialis Presents New Clinical Biomarker Findings at SITC, BioTechX (Businesswire)
"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."
Clinical data
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Xerna TME™ Panel
over1year
Exact Sciences expands leadership in colorectal cancer screening with new data presented at the American College of Gastroenterology 2022 annual meeting (Exact Sciences Press Release)
"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."
Clinical data
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Cologuard®
over1year
Exact Sciences demonstrates power of multi-cancer early detection approach with data presentation at the 2022 European society for medical oncology congress (Exact Sciences Press Release)
"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."
Clinical data
over1year
Mdxhealth acquires Oncotype DX® GPS Prostate Cancer business from Exact Sciences and reports preliminary half year 2022 results (MDxHealth Press Release)
"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."
M&A
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Oncotype DX Genomic Prostate Score® Assay
over1year
Exact Sciences and West German Study Group Announce New Study to Validate Detection of Minimal Residual Disease in Early-Stage Breast Cancer Patients (Exact Sciences Press Release)
"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."
Licensing / partnership • New trial
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Oncotype DX Breast Recurrence Score®Test
over1year
Ultima Genomics and Exact Sciences enter long-term supply agreement aimed at improving patient access to genomic testing by driving down sequencing costs (Exact Sciences Press Release)
"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."
Licensing / partnership
almost2years
Exact Sciences showcases breadth of early detection and treatment guidance portfolio with multiple data presentations at ASCO 2022 (Exact Sciences Press Release)
"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."
Clinical data
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Oncomap™ ExTra test • Oncotype MAP™ Pan-Cancer Tissue Test
almost2years
Updated Guidelines from the American Urological Association Include Genomic Assays, such as the Oncotype DX GPS Test, for the First Time in Localized Prostate Cancer Patients (PRNewswire)
"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."
Clinical guideline
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Oncotype DX AR-V7 Nucleus Detect® test • Oncotype DX Genomic Prostate Score® Assay • Oncotype MAP™ Pan-Cancer Tissue Test
almost2years
Updated ASCO guidelines strongly recommend use of the Oncotype DX Breast Recurrence Score® Test in node-negative and the majority of node-positive early-stage breast cancer patients (PRNewswire)
"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."
Clinical guideline
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Oncotype DX Breast Recurrence Score®Test
2years
Exact Sciences presents data showing improved accuracy of second-generation Cologuard® test and progress toward an even better colorectal cancer screening solution for patients (Exact Sciences Press Release)
"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'."
Clinical data
|
Cologuard®
2years
Exact Sciences Acquires PreventionGenetics to Accelerate Availability of Hereditary Cancer Testing for More Patients (Exact Sciences Press Release)
"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."
M&A
2years
Exact Sciences and OncXerna Announce Licensing Agreement to Help Predict Immunotherapy Response for More Patients (Exact Sciences Press Release)
"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."
Licensing / partnership
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Oncomap™ ExTra test
over2years
New data presented at SABCS® 2021 strengthen value of Oncotype DX Breast Recurrence Score® Test to inform clinical decision-making (Exact Sciences Press Release)
"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."
Clinical data
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Oncotype DX Breast Recurrence Score®Test
over2years
Publication in the New England Journal Of Medicine confirms that tens of thousands of women with node-positive, early-stage breast cancer can avoid chemotherapy with the Oncotype DX® Test (Exact Sciences Press Release)
"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."
Clinical data
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Oncotype DX Breast Recurrence Score®Test
over2years
Exact Sciences, Pfizer end Cologuard copromotion agreement (Genomeweb)
"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."
Licensing / partnership
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Cologuard®
over2years
New 20-year data published in Urologic Oncology validates adverse pathology as predictor of prostate cancer outcomes in clinically low-risk patients (Exact Sciences Press Release)
"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."
Clinical data
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Oncotype DX Genomic Prostate Score® Assay
over2years
Exact Sciences and Jefferson Health Commence collaboration on multi-cancer earlier detection (Exact Sciences Press Release)
"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."
Licensing / partnership
over2years
New Cologuard® modeling data show patient navigation matters when reaching underserved populations for colorectal cancer (CRC) screening (Exact Sciences Press Release)
"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."
Clinical data
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Cologuard®