Roche announces FDA approval of new VENTANA PD-L1 assay

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced approval of the VENTANA PD-L1 (SP142) Assay by the US Food and Drug Administration (FDA) as a complementary diagnostic to provide PD-L1 status on patients who are considering treatment with the FDA approved Roche immunotherapy TECENTRIQ™ (atezolizumab) for metastatic urothelial cancer (mUC). This test is the first to evaluate patient PD-L1 status using immune cell staining and scoring within the tumor microenvironment, providing clinicians with information that may guide immunotherapy decisions.

This personalized cancer immunotherapy and complementary diagnostic is the first major advancement in more than 30 years in the treatment of urothelial cancer (UC) 3. UC is the fourth most common cancer in men in the United States and accounts for 5% of all new cancers reported. About 77,000 new cases of UC are diagnosed in the US annually, with approximately 16,000 deaths occurring each year. Men are three to four times more likely to suffer from this cancer4.

"We are very pleased with the FDA approval of our PD-L1 assay as a complementary diagnostic with TECENTRIQ™," said Ann Costello, Head of Roche Tissue Diagnostics. "Through collaboration with our Roche Pharmaceuticals colleagues, we are committed to transforming science through innovative diagnostics and breakthrough medicines, providing patients a deeper understanding of their disease and immunotherapy options."

"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," said Jack Phillips, Head of Roche Diagnostics North America. "This assay, which supports patients with urothelial cancer - a disease with limited treatment options - has the potential to improve the standard of care."

Roche will 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 may provide additional information for physicians and inform patient dialogue. The PD-L1 (SP142) assay is widely accessible for use with the company's BenchMark ULTRA automated staining instrument.