In Vitro Diagnostic Use Articles & Analysis
9 news found
Heska Corporation (NASDAQ: HSKA; “Heska” or the “Company”), a leading global provider of advanced veterinary diagnostic and specialty solutions, announced today that the Company has entered a definitive agreement to acquire 100% of the share capital of MBio Diagnostics, Inc. d/b/a LightDeck Diagnostics (“LightDeck”), a pioneer in innovative planar waveguide ...
Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced that its partner SkylineDx will present new data showing that its Merlin Test was able to prospectively reduce more than 37% of surgeries in a noninterventional study for newly diagnosed melanoma patients1 . The abstract publication ...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. today announced a collaboration with Eli Lilly and Company (Lilly) for the development of Foundation Medicine’s tissue- and blood-based assays as companion diagnostics for RETEVMO® and other therapies in Loxo Oncology at Lilly’s pipeline. The partnership will initially explore the use of FoundationOne®CDx for adult ...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. today announced that the company has signed agreements for in-network provider status with Humana Military and Health Net Federal Services, which administer the TRICARE health program for military members, retirees and their families (TRICARE).1,2 TRICARE is one of the largest health plans in the United States with 9.6 million ...
Thermo Fisher Scientific today announced the completion of the U.S. Food and Drug Administration (FDA) listing for the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System. The innovative product enables clinical laboratories and assay developers to meet testing demands and enhance their molecular diagnostics workflows. Clinical diagnostic and hospital laboratories across the United States ...
ImmunoCAP Specific IgE alpha-Gal Allergen Component test has been cleared by the U.S. Food & Drug Administration (FDA) for in vitro diagnostic use. Test results can aid specialists and other healthcare providers as they diagnose a patient's sensitization to the alpha-Gal carbohydrate found in mammalian (red) meat and assess his or her risk for an anaphylactic reaction. According to the ...
ImmunoCAP Specific IgE Stinging Insect Allergen Components have been cleared by the U.S. Food & Drug Administration (FDA) for in vitro diagnostic use. Results from these component tests can act as a diagnostic aid to help specialists and other healthcare providers discriminate between true sensitization and cross reactivity, identify culprit insect(s) in patients with inconclusive patient ...
Thermo Fisher Scientific has expanded its portfolio of analytical instruments for clinical diagnostic laboratories with the addition of three systems now listed as Class I medical devices with the United States Food and Drug Administration (U.S. FDA). The portfolio enables clinical diagnostic laboratories to leverage a comprehensive platform for developing sensitive and reliable laboratory ...
Waters Corporation (NYSE: WAT) today announced that the Waters® ACQUITY UPLC® I-Class IVD/Xevo® TQ-S micro IVD System is now manufactured as a U.S. FDA Class I medical device and is CE Marked to the European Directive 98/79/EC (IVDD). This development allows clinical laboratories to access leading innovations in liquid chromatography (LC) and mass spectrometry (MS) technology for the ...