The firm aims to stabilize and protect its existing molecular diagnostics business over the next 12 to 18 months, CEO Jack Kenny said.
The research team said its nanofluidic system increased the proportion of nucleic acid and protein disease biomarkers a billionfold prior to detection.
Within the company's diagnostics segment, revenues for molecular assays in particular declined 21 percent year over year.
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 first tests to be made available through the collaboration will be for Lyme disease and food sensitivity, leveraging PerkinElmer's expertise.
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.
The study compared a variety of serological tests for visceral leishmaniasis that are available in Brazil, a hotspot for the parasitic disease.
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.
The financing will go toward ongoing commercialization of the firm's autoimmune tests and therapeutics promotion business.
The test measures levels of seven autoantibodies to tumor-associated antigens and is designed to detect all forms of lung cancer at any stage.
The new list comprises 122 test categories — 46 general IVDs, 69 IVDs for specific diseases, and seven test categories for screening blood donations.
The deal, which is initially for five years, also covers the Eurasian Customs Union, with an option for other countries in the area.
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 test measures levels of seven auto-antibodies to tumor-associated antigens, and is designed to detect all forms of lung cancer at any stage.
The Almeda, California immunodiagnostics developer had been developing immunoassay technologies for 16 years, with ties to many giants in the industry.