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.
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PD-L1 monoclonal antibody
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.
Read More »Guardant Health introduces Lunar assay
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.
Read More »Roche’s Xofluza approved for influenza treatment
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.
Read More »Home test for CKD monitoring
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.
Read More »National Jewish Health launches assay for NTM drug resistance
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.
Read More »Insight Genetics offers TNBC test
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.
Read More »Thermo Fisher offers plazomicin immunoassay
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.
Read More »CellMax colon cancer screening study
February 2019—CellMax Life announced the kickoff of its Zenith study, a U.S. clinical study for the company’s circulating tumor cell blood test.
Read More »Quest buys lab services business of BBPL
February 2019—Quest Diagnostics has signed a definitive agreement to acquire the assets of the clinical laboratory services business of Boyce and Bynum Pathology Laboratories; BBPL’s anatomic pathology division, long-term care division, and Boyce and Bynum Pathology Professional Services are not part of the transaction.
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