Clinical OMICS

MAY-JUN 2017

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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18 Clinical OMICs May/June 2017 Diagnostics Almac Study IDs Patients at Risk for Mestastatic Prostate Cancer Ventana PD-L1 Assay Attains CE Label Expansion to Inform Lung Cancer Treatment Decisions In early May, Roche launched the Ven- tana PD-L1 (SP263) Assay as an in vitro diagnostic test for anti-PD-1 drug Key- truda (pembrolizumab) to identify untreated and previously treated meta- static non-small cell lung cancer (NSCLC) patients eligible for the immunotherapy. The assay is available in countries accept- ing the CE mark. "Roche first launched the VENTANA PD-L1 (SP263) Assay in September 2016 as a diagnostic test for previously treated metastatic NSCLC patients in countries accepting the CE mark. "We are very pleased to expand its application to include patients being considered for Keytruda immunother- apy as the first line of treatment," said Ann Costello, head of Roche Tissue Diag- nostics. " The assay provides new insights into possible treatment options for this potentially deadly disease." Roche will continue to purs ue regu- latory approval for the Ventana PD-L1 (SP263) Assay in other cancer indications and in other geographies. Almac Diagnostics recently pub- lished the results of a validation study demonstrating the effectiveness of their "Prostate Metastatic Cancer Assay" for identifying prostate cancer patients at a higher risk of metastatic disease following surgical resection. While standard treatments for local- ized prostate cancer, including surgi- cal removal of the prostate gland and radical radiotherapy, cure the major- ity of patients, approximately 10% to 20% will develop metastatic disease that will eventually limit their lifes- pan. The ability to identify high-risk patients would make it possible for cli- nicians to offer additional, potentially life-saving, treatment options. "The problem we have is that current clin- ical factors are informative, but they don't tell us the whole story," Richard Kennedy, M.D., Ph.D., vice president and medical director of Almac Diag- nostics, commented on the motivation behind the assay's development. "We had the hypothesis that there may be a molecular subgroup of pros- tate cancers that have the ability to metastasize," Kennedy elaborated. To test this hypothesis, Almac Diagnos- tics analyzed large archives of forma- lin-fixed paraffin-embedded (FFPE) tissue from primary tumors that led to either metastatic or non-metastatic disease. These analyses revealed a gene expression signature of seventy genes that formed the basis of the Prostate Metastatic Cancer Assay. The study, published in the Journal of European Urology, details a collab- orative, multi-center effort to inde- pendently validate the assay using 322 radical prostatectomy samples. The study's authors used a measurement termed hazard ratio (HR) to assess the assay's ability to identify high-risk patients. The assay, independent of any additional clinical factors, had a HR of 3.2; thus, a patient who tested positive for the gene expression signa- ture identified by the assay would be approximately three times more likely to develop metastatic disease. When applied to the validation study data- set, the standard risk model used in the U.S., CAPRA-S, which combines multiple clinical factors, had a HR of 2.7. Combined the two prognostic tools achieved an overall HR of 7.5 — indicating a much greater ability to identify high-risk patients. Almac intends to publish addi- tional studies that will demonstrate the assay's effectiveness when used with biopsy samples collected prior to radical radiotherapy, and the ability to transfer the assay to different commer- cial platforms.—Meghaan Ferreira VENTANA PD-L1 (SP263) Assay staining in non-small cell lung cancer (NSCLC) with membranous and cytoplasmic staining of the tumor cells. MedicalArtInc / Getty Images

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