News

 

Explore the latest CDx-related innovations from Roche.

Roche BMS Collaboration

MARCH 25, 2022

 

Roche announces collaboration with Bristol Myers Squibb
 

Roche announces collaboration with Bristol Myers Squibb to advance personalised healthcare through digital pathology solutions.

Ventana PDL-1 (SP263) Assay FDA approved

OCTOBER 22, 2021

 

VENTANA PD-L1 (SP263) Assay FDA approved for TECENTRIQ in NSCLC
 

Roche’s VENTANA PD-L1 (SP263) Assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq® (atezolizumab).

Ventana MMR RxDx Assay FDA approved

AUGUST 18, 2021

 
FDA approves VENTANA MMR RxDx Assay to identify patients eligible for JEMPERLI
 

Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumor patients eligible for anti-PD-1 immunotherapy.

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APRIL 22, 2021

 

Roche FDA approval for first CDx to identify endometrial cancer

Roche receives FDA approval for VENTANA MMR RxDx Assay as first companion diagnostic to identify endometrial cancer patients eligible for anti-PD1 therapy.

DISCOVERY Green HRP chromogen

MARCH 18, 2021

 
Roche launches DISCOVERY Green HRP chromogen detection kit

 

Roche launches DISCOVERY Green HRP chromogen detection kit to expand immunohistochemistry multiplexing in cancer research

Roche ALK (D5F3) approved to identify lung patients for LORBRENA

MARCH 09, 2021

 

Roche ALK (D5F3) approved to identify lung patients for LORBRENA

 

Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)

Roche launches two digital pathology image analysis algorithms

JANUARY 11, 2021

 
Roche launches two digital pathology image analysis algorithms

 

New digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis for breast cancer, help drive individual patient treatment strategies.

FDA approves Roche’s cobas EGFR Mutation Test v2

OCTOBER 29, 2020

 

FDA approves Roche’s cobas EGFR Mutation Test v2 as the first companion diagnostic test approved for broad group therapies in the treatment of non-small cell lung cancer (NSCLC)

 

This FDA approved class claim allows the test to be used as a companion diagnostic for all current and future approved EGFR TKI therapies targeting certain EGFR mutations in patients with NSCLC.

Roche launches VENTANA PD-L1 (SP142) Assay in CE markets

AUGUST 28, 2020

 
Roche launches VENTANA PD-L1 (SP142) Assay in CE markets as first companion diagnostic to identify triple-negative breast cancer patients for therapy

 

Helps identify triple-negative breast cancer (TNBC) patients most likely to benefit from treatment with Tecentriq plus chemotherapy.

Roche launches uPath PD-L1 (SP263) image analysis

JULY 06, 2020

 

Roche launches uPath PD-L1 (SP263) image analysis

 

Roche announces the CE-IVD launch of its automated digital pathology algorithm, the uPath PD-L1 (SP263) image analysis for non-small cell lung cancer (NSCLC).

FDA approves Roche’s new VENTANA HER2 Dual ISH test

JUNE 29, 2020

 
FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy

 

FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy.

Roche receives FDA approval for cobas EZH2 Mutation Test

JUNE 19, 2020

 

Roche receives FDA approval for cobas EZH2 Mutation Test as a companion diagnostic for patients with follicular lymphoma

 

Roche announces FDA approval of the cobas EZH2 Mutation Test as a companion diagnostic for TAZVERIKTM (tazemetostat), developed by Epizyme, Inc.