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Results For "Roche-Diagnostics"

37 News Found

Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer
Drug Approval | February 01, 2025

Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.


WHO endorses Roche’s dual-stain cytology testing in its cervical cancer prevention guidelines
Clinical Trials | September 23, 2024

WHO endorses Roche’s dual-stain cytology testing in its cervical cancer prevention guidelines

Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results


Roche responds to WHO’s declaration of health emergency due to mpox outbreak
Healthcare | August 23, 2024

Roche responds to WHO’s declaration of health emergency due to mpox outbreak

Roche confirms that its cobas MPXV test, as well as the LightMix research use only kits, detect the latest mpox virus variants


Roche closes acquisition of LumiraDx’s Point of Care technology
News | August 05, 2024

Roche closes acquisition of LumiraDx’s Point of Care technology

The acquisition of LumiraDx’s Point of Care technology received all required antitrust and regulatory clearances


Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution
News | July 10, 2024

Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution

The built-in AI-trained algorithms will empower users to proactively intervene when their glucose levels require attention and before a complication can even occur


Roche receives FDA clearance on its digital pathology solution for diagnostic use
News | June 20, 2024

Roche receives FDA clearance on its digital pathology solution for diagnostic use

This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis with its digital pathology solutions


Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer
Clinical Trials | April 11, 2024

Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer

Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2


Roche launches three new Factor Xa inhibitor coagulation tests
Clinical Trials | February 14, 2024

Roche launches three new Factor Xa inhibitor coagulation tests

The new tests can support clinical decision making when prescribing direct oral anticoagulants for stroke prevention


Roche to buy LumiraDx’s technology platform for US$ 295 million
News | December 31, 2023

Roche to buy LumiraDx’s technology platform for US$ 295 million

Roche will pay a purchase price of USD 295 million and an additional payment of up to USD 55 million


Abbott India MD Vivek Kamath resigns
People | December 22, 2023

Abbott India MD Vivek Kamath resigns

His resignation would be effective from March 18, 2024