Health Canada Lucira Health SARS-CoV-2 Self-Test Receives Health Canada Conditional Authorization The molecular test kit will be available for Canadians to order online by June and will cost around C$75. GenDx HLA Genotyping Products Receives Health Canada IVD Approval The products combine next-generation sequencing and analysis with the company's NGSengine software to provide high-resolution HLA genotyping information. OraSure Saliva Collection Device Gets Canada Authorization for COVID-19 Testing The device also has Emergency Use Authorization from the US Food and Drug Administration and has CE marking for in vitro diagnostic use. Quidel SARS-CoV-2 Test Receives Expanded FDA Emergency Use Authorization Now, the assay can also be used with the Applied Biosystems 7500 Standard from Thermo Fisher Scientific, Roche's LightCycler 480, and Qiagen's Rotor-Gene Q. SpeeDx Gets Health Canada Approval for Mycoplasma Genitalium ID, Drug Resistance Test The test could potentially enable labs to bring resistance testing in house, rather than send testing out to Canada's National Microbiology Laboratory. Nov 13, 2018 Health Canada Approves Two BCR-ABL Tests Jun 10, 2018 Whole-Genome Sequencing Gaining Traction in Public Health, Outbreak Surveillance Jan 4, 2018 Health Canada Approves DermTech's Pigmented Lesions Assay Jun 21, 2017 3M Listeria Assay Approved by Health Canada Mar 14, 2017 Roche EGFR Mutation Test Approved in Canada Feb 22, 2016 Luminex Receives Canadian Medical Device License for Aries System, Herpes Assay Mar 23, 2015 Illumina Gets Canadian License for MiSeqDx, CF Assays Mar 2, 2015 Seegene Receives Canadian Approval for Allplex Respiratory MDx Test Jan 28, 2015 Luminex Gets Canadian Approval for Drug Metabolism Genotyping Assay Dec 3, 2014 Health Canada Extends Approval of DuPont E. Coli Assay for Food Safety Nov 5, 2014 After Health Canada Approval, Spartan Plans to Launch Point-of-Care CYP2C19 Dx via Pharmacy Pilots Premium Oct 30, 2014 Health Canada Approves Spartan's Rapid CYP2C19 Test for 'Near Patient' Use Oct 10, 2014 GenDx Gets Canadian ISO Certification Aug 12, 2014 IMDx Assays for Abbott Platform Gain Licensure in Canada, Singapore Jun 11, 2014 Canada Approves Roche's HPV Test as a First-line Cervical Cancer Screen May 28, 2014 Canada Approves Meridian Bio's Molecular Assays for M. Pneumonia, B. Pertussis May 7, 2014 NanoString Gets Canadian OK for Prosigna Assay Mar 27, 2014 IMDx VanR Assay for Abbott MDx System Cleared in Canada, Singapore Feb 24, 2014 Canada Clears SQI Test for Celiac Disease Feb 4, 2014 Health Canada Approves Hologic's HPV Genotype Assay for Use on Panther Load More Breaking News Children With Autism May Have Underdeveloped Gut Microbiomes, Metagenomic Analysis Finds Kiromic BioPharma Acquires InSilico Solutions Bio-Rad Laboratories, 10x Genomics Settle IP Lawsuits, Sign Global Cross-Licensing Agreement Scope Fluidics Obtains CE Mark for PCR-Based SARS-CoV-2 Panel MeMed COVID-19 Prognostic Test Receives CE Mark ERS Genomics Licenses CRISPR IP to Japan SLC The Scan Dropped Charges The US Justice Department has dropped visa fraud charges against five Chinese researchers, according to the Wall Street Journal. More Kids The Associated Press says Moderna is expanding its SARS-CoV-2 vaccine study to included additional children and may include even younger children. PNAS Papers on Rat Clues to Human Migration, Thyroid Cancer, PolyG-DS In PNAS this week: ancient rat genome analysis gives hints to human migrations, WDR77 gene mutations in thyroid cancer, and more. Purnell Choppin Dies Purnell Choppin, a virologist who led the Howard Hughes Medical Institute, has died at 91, according to the Washington Post.