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FDA authorizes marketing of first SARS-CoV-2 diagnostic test using De Novo premarket review pathway


FDA authorizes marketing of first SARS-CoV-2 diagnostic test using De Novo premarket review pathway
Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections.
The diagnostic test, which had an Emergency Use Authorization (EUA), was granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The grant of this De Novo request marks an important step in FDA s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency. ....

Jeff Shuren , Janet Woodcock , Emily Henderson , Biofire Diagnostics , Radiological Health , Biofire Respiratory Panel , Drug Administration , Emergency Use Authorization , Sars Cov 2 , Public Health , Respiratory Tract Infections , ஜேனட் மரக்கட்டை , எமிலி ஹென்டர்சன் , கதிரியக்கவியல் ஆரோக்கியம் , அவசரம் பயன்பாடு அங்கீகாரம் , சர்வதேச பரவல் , பொது ஆரோக்கியம் , சுவாச பாதை நோய்த்தொற்றுகள் ,

Kaneka Probiotics launches L. plantarum DR7 for immune support


Kaneka Probiotics launches L. plantarum DR7 for immune support
Texas-based Kaneka Probiotics has launched Lactobacillus plantarum DR7 for immune support supplements, with the strain’s efficacy supported by clinical trials.
The DR7 strain was isolated originally from fresh bovine milk, and its potential benefits respiratory health were reported in a randomized-controlled clinical trial published in the
Journal of Dairy Science ​.
The study included 109 adults randomly assigned to receive either one billion CFUs of DR7 per day or placebo for 12 weeks. The data indicated that the probiotic was associated with decreased levels of pro-inflammatory cytokines such as TNF-alpha and IFN-gamma in the subjects, as well as reduced the duration of nasal symptoms. ....

Mike Kolifrath , Kaneka Probiotics Division , Upper Respiratory Tract , Gut Brain Axis , Vice President , Kaneka Probiotics , Dairy Science , Hx Chong , Beneficial Microbes , Immune Support , Respiratory Health , Probiotics Amp Prebiotics , Respiratory Tract Infections , கனேகா ப்ரோபிஒடிக்ஸ் பிரிவு , மேல் சுவாச பாதை , குடல் மூளை அச்சு , துணை ப்ரெஸிடெஂட் , கனேகா ப்ரோபிஒடிக்ஸ் , பால் அறிவியல் , ஹக்ஷ சோங் , நோய் எதிர்ப்பு சக்தி ஆதரவு , சுவாச ஆரோக்கியம் , சுவாச பாதை நோய்த்தொற்றுகள் ,