Following NICE approval in December 2018 a companion diagnostic test is required to determine PD-L1 levels in the tumour tissue of cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer prescribed treatment with pembrolizumab (Keytruda) or atezolizumab (Tecentriq). PD-L1 testing is funded by NHS England as described in 2017/19 National Tariff High Cost Devices.
The Christie Pathology Partnership (CPP) is one of the first reference laboratories to offer the new companion test. The Ventana PD-L1 (SP142) Assay won FDA approval in July 2018 as a companion diagnostic test to select patients for treatment with atezolizumab. The SP142 assay determines PD L1 expression in immune cells, and the agency requires PD-L1 stained tumour-infiltrating immune cells covering greater ≥5% of the tumour area to be eligible for atezolizumab monotherapy.
“We are pleased to add this companion test to our diagnostic testing services which will enable clinical teams to treat patients with urothelial cancers with newer therapeutic options,” said Dr Pedro Oliveira, Consultant Pathologist at The Christie NHSFT.
Roche also announced last week that it had received FDA approval of the PD-L1 (SP142) assay in identifying triple negative breast cancer patient eligible for atezolizumab plus chemotherapy.
Sue Clark, CPP General Manager said “We are also hugely excited by the addition of the assay to our 2019 pipeline. PD-L1 (SP142) testing in triple negative breast cancer is planned as part of an Early Access to Medicines Scheme (EAMS) approved by MHRA and we plan to be one of the first UK reference laboratories to offer this test”.
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The Christie Pathology Partnership
The Christie Pathology Partnership (CPP) is unique joint venture between The Christie NHSFT, Europe’s largest single site cancer centre and SYNLAB, Europe’s largest laboratory provider. CPP is UKAS accredited to ISO15189 standards offering blood sciences including specialist oncology biochemistry and flow cytometry, cytogenetic analysis, fluorescence in-situ hybridization (FISH), immunohistochemistry and stem cell processing. CPP is fully accredited to ISO-15189.