Pharma Focus Europe

Roche launches two new antibodies to identify key clinical mutations in patients with brain cancer

Friday, February 24, 2023

Roche announced today the launch of the IDH1 R132H (MRQ-67) Rabbit Monoclonal Primary Antibody and the ATRX Rabbit Polyclonal Antibody to identify mutation status in patients diagnosed with brain cancer.

A brain tumour is formed when there is an abnormal growth of cells in the brain. There are two main types of cells in the brain: neurons, the communicators of the nervous system and glial cells, which support and protect neurons and maintain the body’s natural state of balance. Gliomas, brain tumours that develop from glial cells, are the most prevalent type of malignant brain tumours in adults.1

Gliomas that have mutations in the IDH1 and ATRX genes are biologically distinct from tumours that do not carry these mutations. Knowing a patient’s IDH1 and ATRX mutation status enables clinicians to provide personalised care to patients based on their specific tumour classification, including a more informed prognosis, the selection of targeted therapies and inclusion in clinical trials.2

“A patient's IDH1 status helps determine eligibility for clinical trials, which offers more treatment options, and may one day lead to potential targeted therapies for people fighting brain cancer,” said Matt Sause, CEO of Roche Diagnostics.

Time is critical for patients fighting brain cancer. Patients diagnosed with glioblastoma, the most common brain cancer in adults, have an average survival rate of less than one year. Having an understanding of a glioma patient's mutation status will enable clinicians to quickly determine the optimum treatment path for that patient and help predict therapeutic outcomes.

Immunohistochemistry is recommended by all major glioma practice guidelines for determining IDH1 R132H and ATRX mutation status.3-5 When compared to sequencing, identification of IDH1 R132H mutations via immunohistochemistry has been shown to be more accurate, rapid, accessible and cost effective.6 The IDH1 assay can also detect the IDH1 R132H mutation in acute myeloid leukaemia (AML).

Roche’s IDH1 and ATRX assays are optimised and fully-automated on the BenchMark series of instruments. The two tests are now available in the US. They will likely be available in other non-CE markets later this year and in countries that accept the CE mark in 2024.

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