The FDA has granted emergency use authorization for Becton, Dickinson and Company’s (BDX +1.6%) rapid point-of-care test for the detection of the SARS-CoV-2 virus. The assay, performed on the BD Veritor Plus System, generates results in 15 minutes, enabling healthcare professionals to take action (if positive) while the patient is still onsite.
In clinical studies, the test showed 84% sensitivity (correctly identifying true positives) and 100% specificity (correctly identifying true negatives).
Market launch is underway. It expects to file for 510(k) clearance at a later date. It plans to ramp up production to 2M tests per week by the end of September.
Selected COVID-19 rapid test competitors: Abbott (ABT +1.5%), Roche (OTCQX:RHHBY +0.7%), Thermo Fisher Scientific (TMO +3.0%)
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.