FDA OKs Cartridge-Based Companion Diagnostic Test for Colorectal Cancer
The test provides fully automated, sample-to-result testing to identify patients eligible for immunotherapy treatment.
Category: Colorectal
Colorectal
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Colorectal
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Proscia and Owkin Partner on MSI Screening for Colorectal Cancer Using AI
Proscia and Owkin announced a partnership to integrate AI-driven MSI screening technology, expanding access to colorectal cancer diagnostics.
Colorectal
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Universal DX Initiates Clinical Trial for FDA Approval of Colorectal Cancer Test
Universal DX initiated a clinical trial for its colorectal cancer screening blood test with the goal of achieving FDA premarket approval.
FDA Advisory Committee Panel Recommends Approval of Colorectal Blood Test
The FDA’s Medical Devices Advisory Committee recommended approval of Guardant Health’s Shield blood test for colorectal cancer screening.
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Some Patients Repeat Fecal Tests to Delay Colonoscopy
A new study found that 7.4% of patients repeated fecal testing rather than proceeding directly to colonoscopy as guidelines recommend.
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Choice of Tests Doubled Colorectal Cancer Screening
Offering a choice between colonoscopy and a take-home screening kit more than doubled colorectal cancer screening rates.
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Mainz Biomed Colorectal Cancer Diagnostic Part of FDA Trial
Mainz Biomed N.V. announced results from a clinical study to evaluating integrating its portfolio into its colorectal cancer screening tool.
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Mainz Biomed to Present Results of Colorectal Cancer Screening Study
Mainz Biomed will present the findings of a study that evaluated its multimodal screening test for the detection of colorectal cancer.
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FDA Approves Geneoscopy’s Multi-Target Stool RNA Colorectal Cancer Test
Geneoscopy received U.S. FDA approval for ColoSense, a noninvasive colorectal cancer screening test that uses RNA biomarkers.
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Researchers Identify the Critical Gap in Colorectal Cancer Screening
A significant gap exists in ensuring timely follow-up with colonoscopy after a positive stool test, hindering the effectiveness of screening.
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How Effective are Blood Tests for Colorectal Cancer Screening?
New studies are cautioning against the use of blood tests to replace established colorectal cancer screening tests.
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Next-Gen Stool DNA Test for Colorectal Cancer Has High Detection Rate
Researchers say the test has the best performance for the detection of both colorectal cancer and advanced precancerous polyps.
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Blood Test Shows High Accuracy for Colorectal Cancer Detection
The blood test is intended for screening colorectal cancer in people who are of average risk and not experiencing symptoms.
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Preventive Blood Test for Colorectal Cancer Gets FDA Breakthrough Device Designation
The PreveCol test for cancer is aimed at the early detection of biomarkers in blood associated with colorectal neoplasia.
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Guardant Gives Tentative Date of FDA Advisory Panel Review for Shield Blood Test
Guardant Health announced the FDA is scheduled to review the premarket approval application for the company’s colorectal cancer blood test.
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How At-Home Colorectal Cancer Screenings Pose Challenges
Researchers found that about 10% of at-home screening tests for colorectal cancer tests could not be processed, mostly due to patient error.
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DiaCarta Launches OTC at Home Fecal Occult Blood Test
DiaCarta has received US FDA 510(k) clearance for its over the counter (OTC) at home iColon Fecal Occult Blood Test (FOBT).
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Universal DX Collaborates with Quest on Advanced Colorectal Cancer Blood Tests
Universal DX announced a strategic collaboration with Quest Diagnostics designed to improve colorectal cancer screening in the United States.
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