HCV Genedrive Expects CE-IVD Mark for POC SARS-CoV-2 Test by Fall; Advances Hearing Loss, HCV Assays Premium The Manchester, UK-based company had previously planned to have a CE-IVD marked test out by June 30. 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. OraSure Technologies Q4 Revenues Down 1 Percent The firm saw strong increases in international HIV sales of its OraQuick HIV Self-Test product in the quarter. Dec 3, 2019 Co-Diagnostics Joint Venture Gets Clearance in India for Five MDx Tests Nov 6, 2019 OraSure Q3 Revenues Fall 22 Percent; Firm Announces $12M All-Cash Buy of Diversigen Oct 15, 2019 Enzo Biochem Fiscal Q4 Revenues Down 8 Percent Aug 23, 2019 Nucleic Acid Extraction System From Systaaq Diagnostic CE Marked Jun 25, 2019 NeuMoDx Gets CE Mark on Hepatitis B and C Assays Apr 25, 2019 Abbott Positions Alinity Molecular System for Labs Moving Testing to Single Platform Premium Feb 7, 2019 Altona Diagnostics Hepatitis C Virus Kit Gets CE-IVD Mark Dec 18, 2018 Systaaq HBV Assay Receives CE Mark Sep 19, 2018 Cepheid Fingerstick HCV Test Receives CE-IVD Clearance Aug 8, 2018 Genedrive, FIND Partner on HCV Assay Evaluation Study Jul 31, 2018 Hologic Q3 Revenues Grow 2 Percent, Boosted by Diagnostics Jul 25, 2018 Pricing Agreement Expected to Broaden Access to Hologic Infectious Disease Tests Jul 5, 2018 Johns Hopkins Developing POC HCV Test for Clinics to Combat Patient Dropouts Premium May 14, 2018 Genedrive Agrees to Sell Research, Pharmacogenomics Divisions for £1.9M May 2, 2018 Genedrive Validates Near-Patient HCV Assay With Eye to European, Sub-Saharan Africa Markets Premium Nov 21, 2017 Genedrive, Partners Win £600K Grant to Develop Plasma Separation Device Nov 14, 2017 Genedrive, Sysmex Sign Asia Pacific Distribution Agreement for HCV Test Oct 16, 2017 Genedrive, Sysmex Europe Sign EMEA Distribution Agreement for HCV Test, MDx Platform Sep 11, 2017 Genedrive HCV ID Kit Gets CE-IVD Marking Jun 30, 2017 Australian Researchers Employ POC RNA Testing to Address Growing Rate of HCV Infections Premium Load More Breaking News In Ongoing False Advertising Suit, Judge Allows Natera Counterclaims Against Guardant Health Centogene Strikes Rare Disease Target Discovery Deal With Insilico Medicine Dilated Cardiomyopathy Gene Mutations Point to Possible Therapeutic Strategy Ginkgo Bioworks Acquires Massachusetts COVID-19 Testing Firm Mainz Biomed Taps DCN Dx to Aid European Study of Enhanced ColoAlert Assay Parse Biosciences Partners With Research Instruments for Southeast Asia Distribution The Scan Transplant Tests Edited Pig Kidneys The Associated Press reports a University of Alabama-Birmingham team transplanted genetically modified pig kidneys into a brain-dead human patient. UK Changes Some Gene-Edited Crop Rules A new law may enable gene-edited crops to be sold in the UK within about five years, New Scientist says. Pill Works Against Omicron in Lab Pfizer's antiviral pill to treat SARS-CoV-2 appears to work against the Omicron variant, the Wall Street Journal reports. Nature Papers Find Genetic Risk Factor for Smell, Taste Loss in COVID-19; Analyze TB Granulomas In Nature this week: genome-wide association study find locus linked to the risk COVID-19 patients losing their sense of taste or smell, and more.