FDA Approves Roche Assay to Support Cancer Immunotherapy Treatment Decisions 

Roche has received Food and Drug Administration approval for the Ventana PD-L1 (SP142) assay, which is a complementary diagnostic that identifies patients with previously treated metastatic non-small cell lung cancer (NSCLC) or urothelial cancer who might respond to the Roche immunotherapy drug Tecentriq (atezolizumab). The test determines the survival benefit that patients might gain from Tecentriq treatment by measuring their programmed death-ligand 1 (PD-L1) expression levels. 

As the first assay to evaluate PD-L1 expression with both tumor cell and immune cell staining, it uses rabbit monoclonal anti-PD-L1 clone SP142 to detect the protein in formalin-fixed, paraffin-embedded tissue stained with OptiView DAB IHC Detection kit and OptiView Amplification kit. Determination of PD-L1 status is indication-specific, and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity. PD-L1 expression in ≥ 50% TC or ≥ 10% IC as determined by the Ventana PD-L1 (SP142) assay in NSCLC tissue may be associated with enhanced overall survival from Tecentriq. In urothelial carcinoma tissue, PD-L1 expression in ≥ 5% IC as determined by the assay was associated with increased objective response rate in a non-randomized study of Tecentriq. The Ventana PD-L1 (SP142) assay is designed to be performed on the Ventana BenchMark Ultra automated tissue staining instrument. 

Bioneer Test for Zika, Dengue, Chikungunya Eligible for WHO Procuremen 

The World Health Organization (WHO) has assessed and listed Bioneer Corp.’s AccuPower ZIKV (DENV, CHIKV) multiplex real-time RT-PCR kit as the first multiplexing Zika test eligible for procurement to its agencies and member states. This assay detects Zika, dengue, and/or chikungunya virus infection in a single test and was designed to overcome the issues with serological cross-reactivity between these three pathogens that hampers Zika immunoassays. The test’s high sensitivity also enables detection of these pathogens even at low viral load during convalescent phases of infection. Bioneer designed the test to run on the ExiStation Universal Molecular diagnostic system, an integrated molecular diagnostic platform capable of sample-to-result automated processing for up to 96 samples.

WHO assessed the kit under the Emergency Use Assessment and Listing Procedure, a mechanism established by WHO and updated on February 5, 2016 to provide procurement agencies and member states performance assurance for Zika diagnostic products. As CLN reported in November, Bioneer, which is based in South Korea, also previously received Korea Ministry of Food and Drug Safety approval for the AccuPower ZIKV (DENV, CHIKV) kit. 

NYS Approves New York Genome Center’s Clinical Whole Genome Sequencing Test 

The New York Genome Center (NYGC) has received conditional approval from the New York State Department of Health to offer clinical constitutional whole-genome sequence (WGS) testing in its Clinical Laboratory Evaluation Program-certified laboratory. The new service will provide genomic testing for patients with undiagnosed diseases or who are seeking predispositional genetic testing. For the latter patient group, the test reports variants on the American College of Medical Genetics and Genomics’ recommended list of 56 actionable genes, along with autosomal-recessive carrier status for severe pediatric diseases and variants in pharmacogenomics-associated genes. NYGC’s clinical constitutional WGS test enables the use of a single diagnostic procedure to obtain comprehensive results that would normally come from multiple individual tests such as sequencing panels, whole-exome sequencing, chromosomal micro­arrays, and mitochondrial tests. The center also hopes the test will reduce the time required to reach a genetic diagnosis by providing increased diagnostic yield over conventional genetic testing. 

Inova Receives FDA Clearance for IBD, IBS Test

The Food and Drug Adminis­tration has granted Inova Diagnostics clearance for its Quanta Lite Calprotectin Extended Range, an assay that aids in the diagnosis of inflammatory bowel disease (IBD)—specifically Crohn’s disease and ulcerative colitis—and helps ­differentiate IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings. The test, a quantitative enzyme linked immunosorbent assay that detects fecal calprotectin levels, is designed to offer a broader quanti­tative range than other calprotectin assays on the market, according to Inova. The assay provides physicians with guidance prior to performing endoscopic evaluations to determine whether a patient has IBD or IBS. Calprotectin follow-up testing in IBD patients also aids with disease management by detecting indolent and often-missed inflammation. 

FDA OKs Ortho’s Automated Platform 

Ortho Clinical Diagnostics has obtained 510(k) clearance from the Food and Drug Adminis­tration for its Vitros Automation Solutions for use with Ortho’s Vitros Chemistry, Immunodiagnostics, and Integrated Systems. The Vitros Automation Solutions expandable and adaptive platform was designed to enable labs to handle both low and high peak capacity as needs change over time. It features open connectivity, which allows labs to connect to third-party analyzers that complement Vitros Automation Solutions in specialties such as coagulation and hematology, as well as to select immunoassay platforms that broaden menu coverage. The new platform also includes Ortho’s Instrument Manager for data management, as well as refrigerated storage for up to 14,000 samples. Additional features of Vitros Automation Solutions include Ortho’s proprietary Intellicheck Technology, which provides real-time process control, and e-Connectivity Remote Diagnostics Management, which continuously tracks instrument performance and helps to identify specific service needs up to 30 days in advance. 

FDA Approves First Molecular Test for Screening Blood Donors for Sickle Cell Trait 

The Food and Drug Adminis­tration (FDA) has approved Immucor’s PreciseType HEA test for screening blood donors for sickle cell trait (SCT), making this the first FDA-approved molecular assay for SCT screening. Manufactured by Immucor’s wholly owned subsidiary, BioArray Solutions, the PreciseType HEA detects genes that govern the expression of 35 antigens that can appear on the surface of red blood cells. The detailed genetic information the test provides helps clinicians and blood banks ensure that red blood cells from SCT donors are not transfused to sickle cell disease patients, neonates, and other patients who require SCT-negative blood. The test is also designed to overcome the throughput limitations and high false positive rate of solubility testing of sickle hemoglobin in buffer, which is the traditional method for SCT screening.