Biotech | February 17, 2022
Center for Breakthrough Medicines launches analytical testing
More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline
More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline
Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation
Rapid testing produces air sample results in 30 minutes
Unlike “Fast PCR” platforms - which uses LAMP/Isothermal technology and not gold standard RT-PCR - CoviSwift has high accuracy and sensitivity and is suitable for airports and hospitals
Results from the BiologyWorks k(now) molecular test were 99.1% in overall percent agreement with the results of the RT-PCR lab tests
In-house wet testing with live Omicron virus demonstrated that the Antigen test detects the Omicron variant with comparable sensitivity to other variants
The QuickVue antigen tests are able to detect the live Omicron variant with similar performance as with other variants
Rapid antigen testing provides results in just 15 minutes and the information can help reduce the risk of Covid-19 exposure
The Covid-19 At-Home Test uses a simple nasal swab sample to enable individuals to self-test at home and receive accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron
Only antibody authorised in the US for pre-exposure prophylaxis of COVID-19
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