PCR
News on qPCR, digital PCR, amplification, point-of-care testing platforms in genetics, genomics, and molecular diagnostics.
Thermo Fisher Scientific, BioMérieux, Cepheid, Others Gain 510(k) Clearances in November
The US Food and Drug Administration granted clearances to tests for infectious diseases, drug resistances, and chronic diseases, among other clearances.
BioMérieux Gets Special 510(k) Clearance From FDA for Tropical Fever Panel
The panel detects pathogens that cause chikungunya, dengue, leptospirosis, and malaria using the firm's BioFire system.
Cepheid Tuberculosis Assay Receives WHO Prequalification
The WHO noted that Cepheid's test is the first test for tuberculosis and antibiotic susceptibility testing that meets the prequalification standards.
Devyser Fetal RHD Screening Test Receives IVDR Certification
The qPCR-based test can help determine the rhesus D antigen status of the fetus in a pregnant woman.
Becton Dickinson's HPV assay was FDA-approved for use with clinician-collected samples in 2018 and received approval for sample self-collection in May.