$SRNE FDA grants emergency clearance to Danaher’s antibodies test 9:54 a.m. ET — Danaher received emergency clearance from the U.S. Food and Drug Administration for its antibody test, Reuters reported. The decision follows the tightening of FDA guidelines for antibodies tests, as high demand has led to the creation of fraudulent testing kits. Beckman Coulter, a unit of Danaher, has shipped the test to 400 U.S. hospitals and will make more than 30 million tests a month, Reuters reported. Danaher also said it has begun distributing tests in other countries that accept the FDA’s clearance. The test has a specificity rate of 99.6% and 100% sensitivity, meaning the chance of a false negative is low. There is no chance of getting a false positive based on the specificity rate. —Alex Harring
  • 7
  • 1
7 Likes