The US Food and Drug Administration (FDA) has granted approval to Roche Group’s ventana PD-L1 (SP142) assay as a complementary diagnostic to provide PD-L1 status on patients who are considering treatment with tecentriq (atezolizumab) to treat metastatic urothelial cancer (mUC).

Tecentriq (atezolizumab) is an immunotherapy from Roche.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The ventana PD-L1 (SP142) assay product is expected to be used in vitro diagnostic (IVD).

"This assay, which supports patients with urothelial cancer, a disease with limited treatment options, has the potential to improve the standard of care."

The test intends to evaluate patient PD-L1 status using immune cell staining and scoring within the tumour microenvironment, providing clinicians with information that could help in making immunotherapy decisions.

Roche said that the personalised cancer immunotherapy and complementary diagnostic is the first major advancement in the treatment of urothelial cancer (UC).

UC is the fourth most common cancer diagnosed in men in the US and accounts for 5% of all new cancers reported.

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.

Nearly 77,000 new cases of UC are diagnosed in the US per year, with around 16,000 deaths occurring each year.

Men are three to four times more prone to suffer from this cancer.

Roche Diagnostics North America head Jack Phillips said: "Roche’s ability to deliver a predictive test for our pathology customers, who provide important clinical information to oncologists, ultimately benefits patients in search of answers and treatment options.

"This assay, which supports patients with urothelial cancer, a disease with limited treatment options, has the potential to improve the standard of care."

The company intends to continue to pursue regulatory approval for the PD-L1 (SP142) assay in combination with tecentriq in other cancer indications and in other countries.

PD-L1 testing is not required for the use of Tecentriq, but it could provide more information for physicians and inform patient dialogue.

The PD-L1 (SP142) assay is currently accessible for use with Roche’s benchmark ultra automated staining instrument.