MetaMedical™ Solutions Inc

Roche secures CE mark for companion diagnostic for cancer therapy Enhertu

Roche has received a European Union CE mark for the companion diagnostic for Daiichi Sankyo’s and AstraZeneca’s Enhertu (trastuzumab deruxtecan), Ventana HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx (Ventana HER2 test).

Ventana HER2 test can be used to identify patients with low human epidermal growth factor receptor 2 (HER2) expression. These low HER2 patient patients can best benefit from Enhertu, which has been approved in the EU for the treatment of HER2-positive advanced non-small cell lung cancer (NSCLC), breast cancer– either HER2-positive or HER2-low, as well as HER2-positive gastroesophageal junction adenocarcinoma.

The Ventana HER2 test was also approved by the US Food and Drug Administration (FDA) in 2022. It is marketed as the Pathway anti-HER-2 test in the US.

The Ventana HER2 test was used in the Phase III DESTINY-Breast04 trial (NCT03734029) for Enhertu to identify patients with low levels of HER2 protein. The test is powered to identify patients with tumours expressing low levels of HER2, which were historically classified as HER2-negative. 

There has been an increased interest in developing companion diagnostics in recent years, as it can help screen patients likely to benefit from a particular therapy. One of the areas where companion diagnostics are gaining increased traction is oncology. The market for oncology tests is expected to grow from being worth $1.9bn in 2022 to more than $3.1bn in 2030, according to GlobalData analysis.

Last month, Bayer and Thermo Fisher Scientific entered a collaboration to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx). The assays will be used to screen patients eligible for Bayer’s precision cancer therapies.

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In November, Pierre Fabre Laboratories partnered with Foundation Medicine to develop companion diagnostics for NSCLC. The diagnostic will be used to detect patients who will best benefit from Pierre Fabre and Pfizer’s combination regimen of Braftovi (encorafenib) and Mektovi (binimetinib).

Roche has invested in developing companion diagnostics in recent months. Last month, the company signed a partnership agreement with PathAI to leverage AI to develop algorithms for companion diagnostics.

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