Siemens, Roche, Quidel, Becton Dickinson, and several other companies received US Food and Drug Administration (FDA) clearances for tests in February.
Roche, one of the world's leading research-based healthcare companies received clearance for its Elecsys tumor-associated antigen immunological assay. This assay is intended to help in the management of breast cancer patients through quantitative determination of CA 153 in human serum and Li-heparin plasma.
Siemens Healthineers received 510k clearance for point-of-care tests that measure blood urea nitrogen and total carbon dioxide. Intended for use in the diagnosis of kidney diseases and metabolic imbalances, these tests can be run on the firm's handheld Epoc blood analysis system, which was acquired from Abbott last year as part of its purchase of the Epocal division of Abbott subsidiary Alere.
Quidel got approval for two separate tests. The firm got clearance for its Sofia Lyme FIA qualitative test which can help in the diagnosis of Lyme disease, and may be used with the firm's Sofia and Sofia 2 instruments. Around mid-February, Quidel also received clearance for its test to detect and differentiate influenza types A and B. The firm said that the test met FDA criteria to be reclassified as a class II rapid influenza diagnostic test.
The FDA also approved BD Phoenix Automated Microbiology System from Becton Dickinson. The system provides rapid, accurate and reliable detection of known and emerging antimicrobial resistance. Becton Dickinson also received premarket approval for its BD Onclarity HPV assay, a molecular test to detect 14 high-risk types of human papilloma virus. This assay is designed for specimens collected in the BD SurePath liquid-based cytology vial for cervical cancer screening.
For the first time, the FDA also cleared a blood test to evaluate concussion from Banyan Biomarkers. Other tests that received FDA approval in February include Guardant Health's Guardant360 liquid biopsy assay, Mesa Biotech's Accula Flu A/Flu B test cassette, DiaSorin's Liaison BRAHMS PCT II Gen assay, Alfa Scientific Designs' immunoassay fecal occult blood test and Vela Diagnostics' Sentosa SA201 HSV-1/2 PCR test.