February 2019—Qiagen launched the QIAcube Connect, the next generation of the QIAcube instrument. QIAcube Connect fully automates the lysis, bind, wash, and elute steps of the Qiagen spin columns (which can also be used manually) for DNA, RNA, and protein sample processing. It is compatible with a range of the company’s sample technologies and can be used to automate more than 80 Qiagen kits with more than 3,000 proven protocols.

February 2019—Siemens Healthineers and Healthy.io have announced a worldwide original equipment manufacturer alliance in which Siemens urinalysis reagents will integrate into Healthy.io’s smartphone-based urinalysis system to provide a home testing option to monitor kidney function.

February 2019—The Lunar assay, a new blood-based assay intended to detect early-stage cancer and recurrence of disease, is available from Guardant Health for research use by biopharmaceutical and academic researchers.

February 2019—Insight Genetics launched its proprietary Insight TNBCtype, a test for categorizing triple-negative breast cancer tumors into distinct molecular subtypes through its wholly owned CLIA- and CAP-accredited laboratory, Insight Molecular Labs.

February 2019—Roche announced that the FDA has approved Xofluza (baloxavir marboxil) for the treatment of acute, uncomplicated influenza in people 12 years of age and older. Xofluza is a single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease.

February 2019—Leica Biosystems launched a programmed death-ligand 1 antibody. The PD-L1 1 (73-10) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of endogenous PD-L1 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the company’s fully automated Bond system.

February 2019—National Jewish Health Advanced Diagnostic Laboratories has launched a line probe assay to detect nontuberculous mycobacteria infections and identify NTM species and drug-resistance markers at a molecular level within 48 hours after obtaining a sample from culture.

February 2019—Thermo Fisher Scientific received FDA clearance for its de novo submission of its QMS Plazomicin Immunoassay. This quantitative immunoassay measures the concentration of a novel therapeutic antibiotic, plazomicin, using the Beckman Coulter AU 680 automated clinical chemistry analyzer. Plazomicin (Zemdri, Achaogen) is a next-generation aminoglycoside being used to treat patients with complicated urinary tract infections.

February 2019—The Food and Drug Administration approved gilteritinib (Xospata, Astellas Pharma) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia with an FLT3 mutation as detected by an FDA-approved test.