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Biodesix Blood-Based Diagnostic Testing Approach To PD-L1 Detection Shows Concordance with Immunohistochemistry

Biodesix presented preliminary data evaluating a blood-based PD-L1 assay to identify patients who may benefit from cancer immunotherapies. The data were presented last week at the AACR-NCI-EORTC conference. The study was conducted in collaboration with Dr. Michael Pritchett, from FirstHealth Moore Regional Hospital, Pinehurst Medical Clinic, and Dr. Jiaxin Niu, from Banner MD Anderson Cancer Center.

Blood-based Diagnostic Assay from Biodesix Measures Immunotherapy Biomarker PD-L1

New data from Biodesix® evaluating an assay in development demonstrated the potential to measure circulating PD-L1 through mRNA in blood through multiplexed droplet digital™ PCR (ddPCR, Bio-Rad, Inc.) detection. The assay uses proprietary RNA isolation methods consistent with Biodesix’s commercialized GeneStrat® ALK, ROS1, and RET variant tests. Existing immunohistochemistry (IHC) PD-L1 tissue tests are used to identify patients who may benefit from cancer immunotherapies. The data were presented last week at the ASCO-SITC Clinical Immuno-Oncology Program in Orlando, Florida.

Scientists Discover Why Some Cancers May Not Respond to Immunotherapy

UCLA scientists have discovered that people with cancers containing genetic mutations JAK1 or JAK2, which are known to prevent tumors from recognizing or receiving signals from T cells to stop growing, will have little or no benefit from the immunotherapy drug pembrolizumab. This early-stage research has allowed them to determine for the first time why some people with advanced melanoma or advanced colon cancer will not respond to pembrolizumab, an anti-PD-1 treatment.

LabCorp to Offer New PD-L1 Test for Bristol-Myers Squibb’s OPDIVO Following Collaboration in Clinical Trial

Laboratory Corporation of America [®] Holdings (LabCorp [®] ) (NYSE: LH) recently announced the nationwide availability of a new FDA-approved diagnostic test for PD-L1 associated with the expanded approval of Bristol-Myers Squibb Company’s (BMS) OPDIVO [®] (nivolumab) for the treatment of all appropriate patients with previously-treated non-small cell lung cancer (NSCLC). The PD-L1 IHC 28-8 pharmDx assay was developed by Dako, an Agilent Technologies company. The assay was used to assess PD-L1 expression in the Phase 3 CheckMate 057 trial, in which OPDIVO demonstrated superior overall survival compared to chemotherapy in patients with previously treated metastatic non-squamous NSCLC. This approval expands the indication for OPDIVO to include previously treated non-squamous NSCLC in addition to the squamous NSCLC indication. The test, although not required for OPDIVO, is a new tool that provides physicians with information on the potential survival benefit of treatment with OPDIVO.

Quest Diagnostics Introduces Dako’s PD-L1 Companion Diagnostic for KEYTRUDA, Merck’s Anti-PD-1 Therapy for Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 with Disease Progression On or After Platinum-Containing Chemotherapy

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced that it will provide clinical laboratory testing using the PD-L1 IHC 22C3 PharmDx™ immunohistochemistry companion diagnostic.