Inivata today announced it has launched its InVisionFirst Lung liquid biopsy in the U.S. through a commercial partnership with NeoGenomics. The device is a ctDNA next-generation sequencing liquid biopsy assay testing 37 genes that are relevant to the care of advanced non-small-cell lung cancer. The results are delivered within seven days and the test is […]
Lantheus, Progenics complete merger
Lantheus Medical Imaging (NSDQ:LNTH) parent company Lantheus Holdings announced the completion of its merger with Progenics Pharmaceuticals. Progenics, an oncology company developing medicines and artificial intelligence-based technologies for finding, fighting and following cancer, entered into a merger agreement with Lantheus that was first announced on Oct. 2, 2019. Get the full story at our sister site, MassDevice.
Clinical trials ramping up for potential coronavirus-fighting drugs
Bausch Health (NYSE:BHC) announced today that it initiated a clinical trial program in Canada to investigate the use of Virazole for treating COVID-19. With today’s announcement, Bausch joins Eli Lilly (NYSE:LLY) and Care Access Research, which both announced clinical testing of coronavirus therapies last week. Bausch’s Virazole is currently approved in the U.S. and Canada, among other […]
Qosina touts single-use bioprocessing components for coronavirus response
With the bioprocess industry mobilizing to support the development of tests, vaccines and treatments for COVID-19, medtech distributor Qosina said that its supply of single-use bioprocessing components can offer significantly reduced time to clinic and market over multi-use systems during situations like the coronavirus pandemic. Ronkokoma, N.Y.-based Qosina said it also provides 3D CAD models and […]
Bio-Rad launches COVID-19 assay
Bio-Rad Laboratories (NYSE:BIO) today said it is launching is blood-based immunoassay kit to identify COVID-19 antibodies. The assay is currently undergoing clinical evaluation in several hospitals, but 700 samples of data have shown specificity above 99%. After being infected with SARS-CoV-2, viral antigens stimulate the immune system to produce antibodies and fight the virus. Bio-Rad suggests […]
Owlstone Medical partners with Thermo Fisher Scientific for breath biopsies
Owlstone Medical last week announced that it has forged a partnership with Thermo Fisher Scientific‘s (NYSE:TMO) to advance non-invasive breath sampling in disease detection. Through the agreement, both companies will integrate the Thermo Scientific Q Exactive GC Hybrid Quadrupole-Orbitrap MassSpectrometer into Owlstone Medical’s Breath Biopsy platform. The collaboration will hopefully qualify the mass analyzer for […]
Abbott, Medtronic ink diabetes pacts with Sanofi, Novo Nordisk
Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) today announced separate data-sharing deals for digital diabetes management solutions. Abbott is partnering with Sanofi (NYSE:SNY) to integrate glucose sensing and insulin delivery to help people manage their diabetes. The two companies plan to develop tools to combine Abbott’s FreeStyle Libre technology with insulin dosing information for smart pens, insulin titration apps and […]
FDA doubles down on warfarin test strip recall
The FDA this week alerted patients and doctors about test strips used to monitor levels of the blood thinner warfarin, expanding and reiterating its warning that the products shouldn’t be used to adjust a person’s drug dosage. The agency’s latest notice is related to the Class I recall of Roche‘s CoaguChek meters and test strips, […]
FDA issues Class I recall for Roche Diagnostics’ warfarin test strips
The FDA today issued a Class I recall for certain lots of Roche Diagnostics‘ warfarin test strips used with the CoaguCheck test meter devices. Roche voluntarily recalled the strips in September, warning that for patients and doctors who use at-home devices to monitor levels of the blood thinner, the devices may yield inaccurate results. The […]
FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence
TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence. The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter […]
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