May 18, 2016
The VENTANA PD-L1 (SP142) Assay approved as a complementary diagnostic for TECENTRIQ™ (atezolizumab) immunotherapy
Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced approval of the VENTANA PD-L1 (SP142) Assay¹ by the US Food and Drug Administration (FDA) as a complementary diagnostic to provide PD-L1 status on patients with metastatic urothelial cancer (mUC) who are considering treatment with the FDA approved Roche immunotherapy TECENTRIQ™ (atezolizumab). This test is the first to evaluate patient PD-L1 status using immune cell staining and scoring within the tumour microenvironment, providing clinicians with information that may guide immunotherapy decisions.²
This personalised cancer immunotherapy and complementary diagnostic for mUC 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 cancer.4
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.
About the VENTANA PD-L1 (SP142) Assay
The PD-L1 (SP142) assay is available on the BenchMark ULTRA automated staining instrument and uses the OptiView DAB IHC Detection Kit with OptiView Amplification. The PD-L1 (SP142) assay performs specific staining of tumour cells and immune cells.
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