FDA grants approval to Roche’s complementary test for urothelial carcinoma

2 May 2017 (Last Updated May 2nd, 2017 18:30)

The US Food and Drug Administration (FDA) has granted approval to Roche's new biomarker test VENTANA PD-L1 (SP263) as a complementary diagnostic to identify programmed death ligand (PD-L1) status in urothelial carcinoma patients.

FDA grants approval to Roche’s complementary test for urothelial carcinoma

The US Food and Drug Administration (FDA) has granted approval to Roche's new biomarker test VENTANA PD-L1 (SP263) as a complementary diagnostic to identify programmed death ligand (PD-L1) status in urothelial carcinoma patients.

The approval is valid for locally advanced or metastatic urothelial carcinoma (mUC) patients who are potential candidates to receive treatment with Imfinzi (durvalumab), AstraZeneca's anti-PD-L1 immunotherapy.

The test uses tumour and immune cell staining, as well as scoring in the tumour microenvironment to examine the status of PD-L1.

Roche tissue diagnostics head Ann Costello said: "Urothelial carcinoma is an area of significant unmet medical need.

"We are very pleased the VENTANA PD-L1 (SP263) has received FDA approval as it will serve as a powerful tool to help inform physicians about appropriate treatment options for their patients."

"It will serve as a powerful tool to help inform physicians about appropriate treatment options for their patients."

The diagnostics firm is working towards obtaining regulatory approval for its PD-L1 (SP263) assay in other cancer indications in the country, as well as international markets.

Roche Diagnostics' UK and Ireland division has introduced a new self-monitoring device called CoaguChek INRange metre for patients receiving warfarin anticoagulant therapy.

Through an app on their phone, patients can reduce the number of clinic visits by sending their results using a wireless connectivity. 

A survey carried out by Atrial Fibrillation Association (AFA) found that 86% of patients on warfarin prefer self-monitoring to avoid clinic visits.

CoaguChek INRange metre enables patients to set reminders and add comments to specific results.


Image: VENTANA PD-L1 (SP263) Assay staining in urothelial carcinoma. Photo: courtesy of PRNewswire/Roche.