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Until March 2018, when the patent in question expires, Cenata will have its Harmony test performed by Medirex in Slovakia.
Roche's HbA1c test, along with an immunoassay system from Shenzhen New Industries Biomedical, and a celiac test from Immco also received 510(k) clearance last month.
Anticipating a potential cut into its portfolio from competitors' mass specs, Roche said last week at AACC that it will develop its own mass spec-based analyzer in response.
The firm said that immunoassays had 19 years in a row of double-digit growth, driven in part by an automated workflow approach to achieving lab efficiencies.
The Ventana assay is an immunohistochemistry-based companion diagnostic that identifies ALK-positive NSCLC patients eligible for the Novartis drug Zykadia.
The CE-marked test enables health professionals to distinguish between HIV-1 and HIV-2, and runs on the fully automated Cobas 6800/8800 systems.
Thermo Fisher Scientific's PCT assay for the diagnosis of sepsis was among a few tests that received 510(k) clearance last month.
The test, which simultaneously detects MRSA and Staphylococcus aureus, is designed to run on the company's Liat PCR point-of-care platform.
Enzo's patent relates to modified nucleotides for diagnostic and therapeutic applications, and is central to separate ongoing lawsuits with diagnostic developers.
The fourth-generation assay is for the in vitro qualitative assessment of HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2 in human serum and plasma.