Logo

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

Breaking News
The Scan

Should've Been Spotted Sooner

Scientists tell the Guardian that SARS-CoV-2 testing issues at a UK lab should have been noticed earlier.

For Martian Fuel

Researchers have outlined a plan to produce rocket fuel on Mars that uses a combination of sunlight, carbon dioxide, frozen water, cyanobacteria, and engineered E. coli, according to Gizmodo.

To Boost Rapid Testing

The Washington Post writes that new US programs aim to boost the availability of rapid at-home SARS-CoV-2 tests.

PNAS Papers on Strawberry Evolution, Cell Cycle Regulators, False-Positive Triplex Gene Editing

In PNAS this week: strawberry pan-genome, cell cycle-related roles for MDM2 and MDMX, and more.