Company Product Description Indication Status
Cytosorbents Corp., of Monmouth Junction, N.J. Cytosorb Blood purification technology Treats cytokine storm and deadly inflammation in critically ill and cardiac surgery patients U.S. FDA granted breakthrough designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery
Endospan Ltd., of Herzlia, Israel Nexus Aortic Arch Stent Graft system Branched stent graft Treatment of patients with a dilative lesion in or near the aortic arch U.S. FDA granted breakthrough designation
Shanghai Fosun Pharmaceutical (Group) Co. Ltd, of Shanghai COVID-19 RT-PCR Detection kit RT-PCR test; targets the ORF1ab, N and E genes; can complete the detection of 96 samples within 2 hours For the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar
lavage, and nasopharyngeal wash/aspirate or nasal aspirate)
Received emergency use authorization from the U.S. FDA
Foundation Medicine Inc., of Cambridge, Mass. Foundationone Cdx Comprehensive genomic profiling test for solid tumors Identifies patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion, who may benefit from Pemazyre Received U.S. FDA approval as a companion diagnostic for Pemazyre (pemigatinib, Incyte Corp.)
Genosensor Corp., of Tempe, Ariz. GS COVID-19 RT-PCR kit RT-PCR test runs on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument For the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs, nasal swabs and mid-turbinate swabs Received emergency use authorization from the U.S. FDA
Osang Healthcare Co. Ltd., of Anyang, South Korea Genefinder COVID-19 Plus Realamp kit Real-time PCR assay; targets the RdRp gene, E gene and N gene For the qualitative detection of SARS-CoV-2 nucleic acids in nasopharyngeal, oropharyngeal, nasal, and mid-turbinate nasal swab specimens, bronchoalveolar lavage fluid and sputum Received emergency use authorization from the U.S. FDA

Notes

For more information about individual companies and/or products, see Cortellis.

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