HCV
Genedrive Expects CE-IVD Mark for POC SARS-CoV-2 Test by Fall; Advances Hearing Loss, HCV Assays
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The Manchester, UK-based company had previously planned to have a CE-IVD marked test out by June 30.
BioLytical Laboratories Obtains CE Mark for One-Minute HCV Antibody Test
The firm said that the test is 99 percent accurate and runs on its Insti platform, which performs antibody testing from fingerstick whole-blood samples.
OraSure Technologies Q4 Revenues Rise 27 Percent, Beat Analysts' Estimate
The firm attributed its quarterly and annual revenue gains primarily to sales of COVID-19 testing sample collection devices.
OraSure Technologies Q2 Revenues Drop 25 Percent, Miss Analysts Estimates
The firm said declines across most business areas were slightly offset by increases in sales of sample collection devices.
FDA Proposes Reclassification of HCV RNA, Antibody Tests
If the proposal is finalized, the tests will go through a less burdensome process to obtain marketing clearances.
Feb 19, 2020
OraSure Technologies Q4 Revenues Down 1 Percent
Oct 15, 2019
Enzo Biochem Fiscal Q4 Revenues Down 8 Percent
Aug 6, 2019
OraSure Technologies Q2 Revenues Down 11 Percent
Jun 25, 2019
NeuMoDx Gets CE Mark on Hepatitis B and C Assays
May 8, 2019
OraSure Technologies Q1 Revenues Down 28 Percent
Apr 25, 2019
Feb 6, 2019
OraSure Technologies Q4 Revenues Down 3 Percent
Dec 18, 2018
Systaaq HBV Assay Receives CE Mark
Nov 7, 2018