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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.