Marketplace Archives

December 2018—Beckman Coulter launched Kaluza C Flow Cytometry Analysis Software, which aims to streamline clinical QC reporting and address standardization issues in flow cytometry. Kaluza C improves the visualization and analysis of rare events. It makes it possible to process large, multicolor files with up to 20 million events and set the plot resolution according to the gate level. The software enables the operator to focus on a limited number of events to preserve the integrity of the scatterplot.

December 2018—GenomOncology announced that Emory Healthcare is using GenomOncology’s GO Pathology Workbench system as part of its clinical reporting process.

December 2018—Sakura Finetek USA launched the Tissue-Tek Prisma H&E Stain Kit #1, specifically designed for the Tissue-Tek Prisma line of stainers.

December 2018—Chembio Diagnostics announced FDA emergency use authorization for its DPP Ebola Antigen System for use with human capillary fingerstick whole blood, EDTA venous whole blood, and EDTA plasma. The test detects viral antigens and provides qualitative results in 15 to 20 minutes when used with the handheld, battery-operated DPP Micro Reader.

December 2018—Myriad Genetics announced FDA approval of its BRACAnalysis CDx to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are eligible for treatment with Pfizer’s PARP inhibitor, Talzena (talazoparib).

December 2018—BD announced the availability of the CE-marked BD Max MDR-TB panel in Europe. Clinicians can use the single PCR-based molecular diagnostic test to simultaneously detect bacteria that cause tuberculosis and determine if the bacteria contain mutations associated with resistance to two first-line drugs, isoniazid and rifampicin.

December 2018—Mawi DNA Technologies launched its iSwab-Cells cell stabilization product line. Designed to collect and stabilize intact cells for up to four weeks at room temperature, the sample collection system enables users to perform multiple omics analyses from the same sample.

December 2018—The FDA has granted 23andMe de novo authorization to offer direct-to-consumer reports on pharmacogenetics. The authorization allows 23andMe to report variants in multiple genes that are associated with how an individual may metabolize some medications.

December 2018—Sysmex Inostics announced publication of a study in the Journal of Molecular Oncology (Rowe SP, et al. 2018;12[10]:1661–1672) highlighting the clinical value of blood-based ctDNA mutation testing to complement standard-of-care management of patients with advanced melanoma.

December 2018—LGC Maine Standards has released its Validate Body Fluids kit, 205bf. The kit, in a simulated body fluid matrix, will assist in the documentation of linearity, calibration verification, and verification of the reportable range for albumin, amylase, cholesterol, creatinine, glucose, lactate, lactate dehydrogenase, total protein 2, triglycerides, and urea nitrogen.