The research team said its nanofluidic system increased the proportion of nucleic acid and protein disease biomarkers a billionfold prior to detection.
The clearance marks the first time that the tests have been indicated to follow a new paradigm in which two enzyme immunoassay tests can be conducted concurrently or sequentially, the FDA said.
The company's diagnostics segment's revenues were up 6 percent, while its discovery and analytical solutions segment's revenues grew less than 1 percent.
The firms said that Bio-Techne's Ella platform provides the sensitivity needed to provide analysis of the Nf-L biomarker for neurodegenerative diseases.
The company said it got CE marking for use of its Vitros NT-proBNP II immunodiagnostic assay to diagnose and assess heart failure and enable risk stratification.
Danaher's life sciences revenues grew 6 percent, while its diagnostics revenues rose nearly 5 percent, including an increase of more than 20 percent at Cepheid.
Chembio said it will receive funding subject to satisfying milestones to develop a test that leverages its immunoassay platform and hand-held optical analyzer.
The firm said that its molecular diagnostics sales growth in the quarter was negatively impacted by non-governmental organization purchasing patterns in Africa.
Treatment of Chagas disease can be lengthy and there is currently no available method to confirm whether a patient has been cured, according to the firm.
Rapid Biosensor Systems said its point-of-care pre-production breath system has achieved high performance during TB field testing in Ethiopia and India.
The Almeda, California immunodiagnostics developer had been developing immunoassay technologies for 16 years, with ties to many giants in the industry.
