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The study found that for some patients the standard practice of performing a second confirmatory blood test is not necessary, which could streamline care.
Kurin alleges Magnolia has made false claims about its technology’s false-positive rates and contamination rates, as well as misleading claims about FDA clearance.
Echo Lumena is Immucor's fifth-generation immunohematology instrument, and with the fully automated NEO platform, they offer a standardized workflow solution for laboratories.
The push-button device, which works by firing an array of microneedles into an individual's arm, was cleared by the FDA last year.
BD and the FDA said that a chemical called thiuram found in certain BD blood collection tubes may render results from Magellan's LeadCare blood lead tests inaccurate.
The firm aims to have its test on the European clinical market by early next year, followed by a launch in the US.
The firm offers a high-throughput, automated and a low-throughput, manual solution and now plans to address mid-range needs with two new instruments.
Despite the FDA approval, Oxford Immunotec could still exit the business of blood screening for babesia, one analyst said.
The test from Banyan Biomarkers called the Brain Trauma Indicator measures the levels of the proteins UCH-L1 and GFAP that are released into the blood.
McKesson will exclusively distribute Sysmex's XW-100 system, a CLIA-waived complete blood count diagnostic instrument starting in the spring.