CDx news
Explore the latest CDx-related innovations from Roche.
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.
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).
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.
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.
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
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)
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.
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.
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.
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).
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.
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.