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Home » Exact Sciences Corp.

Articles Tagged with ''Exact Sciences Corp.''

guardant bloodkit

Guardant wins nod from FDA for Shield test for colorectal cancer​

July 29, 2024
By Mark McCarty
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.
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Colon cancer illustration

FDA greenlights Geneoscopy’s Colosense colorectal cancer screening test

May 8, 2024
By Annette Boyle
This time a positive result for a cancer screening test brought good news, as Geneoscopy Inc. secured U.S. FDA approval for its RNA screening test for colorectal cancer. The agency based its decision on strong results from the phase III CRC-PREVENT trial in its approval of the noninvasive test for use in individuals aged 45 years and older with average risk for the disease.
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Health professional touching screen, digital/medical icons
AACR 2024

Seekin, Exact liquid biopsies advance early cancer detection

April 10, 2024
By Annette Boyle
Exact Sciences Corp., Seekin Inc. and Serum Detect Inc. presented encouraging results for the field of multicancer early detection at the American Association for Cancer Research annual meeting in San Diego April 6-10, but delays in coverage may slow further progress.
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Esophageal cancer

Cyted gets FDA approval for capsule sponge device

Feb. 6, 2024
By Shani Alexander
Cyted Ltd. received U.S. FDA 510(k) clearance for its Endosign capsule technology, a non-endoscopic capsule sponge device used to collect pan-esophageal samples to detect esophageal pre-cancer and other conditions. The company believes that the minimally invasive test will be able to help prevent deaths from esophageal cancer when offered as a screening test to people on long-term medication for heartburn.
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Genomic Health slapped with $32M hit over cancer testing practices

Oct. 3, 2023
By Mark McCarty
The U.S. Department of Justice (DOJ) reported on October 2 that Genomic Health Inc. (GHI), now a subsidiary of Exact Sciences Corp., has agreed to pay $32.5 million to settle allegations that the company violated the False Claims Act (FCA). The allegations include that GHI had manipulated the dates upon which a test was administered in order to boost revenues from public health programs, an activity that ended up costing the company double damages.
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Study shows Exact benefit of early cancer diagnosis

May 26, 2023
By Annette Boyle
Exact Sciences Corp.’s long-term analysis of results from the Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing (DETECT-A) study found that all patients diagnosed and treated for stage I or II cancers identified through its blood-based multi-cancer early detection (MCED) test remained cancer-free more than four years after diagnosis. Half of all the participants with cancer detected remained alive at four years, notable because most of the detected cancers had no recommended screening tests or standards. The results will be presented at the American Society of Clinical Oncology meeting June 2-6.
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Human colon cancer cells.
Digestive Disease Week 2023

Guardant, Exact Sciences demonstrate value of non-invasive CRC tests at DDW

May 10, 2023
By Annette Boyle
Presentations at the Digestive Disease Week 2023 conference highlighted the strong performance of non-invasive tests for early-stage colorectal cancer. Both Guardant Health Inc. and Exact Sciences Corp. aim to increase acceptance of their tests for CRC to drive higher screening rates, as the preparation and invasive nature of colonoscopy continue to depress participation, even as rates of CRC are rising sharply among younger adults.
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Box for Oncoextra kit

Exact Sciences’ tumor test drives personalized cancer treatment

Feb. 23, 2023
By Shani Alexander
A cancer therapy test unveiled by Exact Sciences Corp. will be able to provide a complete molecular picture of a patient’s tumor allowing for them to receive the most effective treatment as quickly as possible. Exact’s Oncoextra therapy selection test, recently launched in the U.S., enhances the ability of doctors to characterize and understand solid tumors.
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Acute myeloid leukemia

Investors not so hot on Burning Rock despite breakthrough designation for multi-cancer diagnostic

Jan. 3, 2023
By Annette Boyle
Burning Rock Biotech Ltd.’s share price flared up on Tuesday morning on news of U.S. FDA breakthrough device designation for its Overc multi-cancer detection blood test (MCDBT). The stock closed on Dec. 30, 2022, at $2.26 and rose sharply on the announcement to open at $2.89. By the end of the day, however, the stock had sunk to $2.15.
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Human colon cancer cells.

Exact Sciences and Grail show benefits of multi-cancer early detection screening at ESMO

Sep. 12, 2022
By Annette Boyle
Some of the most exciting news out of the European Society for Medical Oncology Congress 2022 in Paris surrounded the rapidly evolving field of multi-cancer early detection (MCED), which offers the dual benefits of identifying malignancies at a more easily treated local stage and enabling screening for the 70% of cancers that lack recommended screening tests.
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