Colorectal Cancer

Jury awards Guardant nearly $293M in lawsuit against Natera

By LabPulse.com staff writers

A federal jury in the U.S. District Court for the Northern District of California ruled in favor of Guardant Health in a lawsuit the company filed against Natera in May 2021.

November 26, 2024

Mainz Biomed, Thermo Fisher collaborate on CRC screening test

By LabPulse.com staff writers

Mainz Biomed and Thermo Fisher Scientific will jointly develop and potentially commercialize Mainz Biomed's next-generation colorectal cancer (CRC) screening test.

November 12, 2024

CMS Medicare fee schedule includes blood tests for CRC screening

By LabPulse.com staff writers

In the 2025 Medicare Physician Fee Schedule final rule, the U.S. Centers for Medicare and Medicaid Services (CMS) updated coverage for a complete colorectal cancer (CRC) screening to include Medicare-covered blood-based biomarker CRC screening tests.

November 5, 2024

Exact Sciences gets FDA approval for next-gen Cologuard Plus test

By LabPulse.com staff writers

Exact Sciences has received U.S. Food and Drug Administration (FDA) approval for its next-generation Cologuard Plus colorectal cancer (CRC) screening test.

October 7, 2024

Geneoscopy adds N.Y. state lab permit for wider ColoSense testing

By LabPulse.com staff writers

Noninvasive colorectal cancer screening test developer Geneoscopy has received a laboratory permit from the New York State Department of Health.

October 1, 2024

New laboratory developed tests for colorectal cancer screening get boost from CMS

By Liz Carey

Clinical laboratory test manufacturers aim for estimated 60 million unscreened Americans as CMS meets them with a broad CRC screening test definition and proposed coverage changes in 2025.

July 31, 2024

Geneoscopy files countersuit against Exact Sciences in patent infringement dispute

By LabPulse.com staff writers

Geneoscopy filed a lawsuit on June 28 against Exact Sciences asserting multiple claims for damages in federal court in the District of Delaware, in the latest development in the ongoing patent dispute between the two companies.

July 1, 2024

Guardant's CRC screening test receives advisory committee recommendation

By LabPulse.com staff writers

Guardant's blood-based Shield screening test for colorectal cancer (CRC) has received the recommendation of the U.S. Food and Drug Administration's Medical Devices Advisory Committee, an important milestone on its path to approval.

May 28, 2024

Geneoscopy receives FDA approval for CRC screening test

By LabPulse.com staff writers

Geneoscopy announced that the U.S. Food and Drug Administration (FDA) has approved ColoSense, the firm's noninvasive multitarget stool RNA colorectal cancer (CRC) screening test.

May 7, 2024

Geneoscopy requests review of Exact Sciences patent, dismissal of lawsuit

By LabPulse.com staff writers

In the latest development in the patent infringement dispute between the two companies, Geneoscopy has petitioned the U.S. Patent and Trademark Office for inter partes review, challenging the patent in contention held by Exact Sciences.

January 12, 2024

Universal DX partners with Quest Diagnostics, closes $70M series B financing round

By LabPulse.com staff writers

Liquid biopsy firm Universal DX and Quest Diagnostics have formed a strategic collaboration under which Quest will exclusively offer services for Universal DX’s Signal-C colorectal cancer screening test in the U.S.

November 21, 2023

FDA grants approval to Takeda’s metastatic colorectal cancer therapy

By LabPulse.com staff writers

The U.S. Food and Drug Administration (FDA) has approved a chemotherapy-free oral target therapy for patients who have been previously treated for metastatic colorectal cancer (mCRC).

November 9, 2023

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