FDA grants EUA for PathogenDx COVID-19 test

LabPulse.com staff writers
Apr 26, 2021
2021 04 27 22 24 2298 Nasal Swab Test 400

The U.S. Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) to PathogenDx for the company's microarray-based COVID-19 test, DetectX-Rv.

DetectX-Rv is a reverse transcription polymerase chain reaction (RT-PCR) and DNA microarray test that uses material from nasopharyngeal, oropharyngeal, midturbinate, and anterior nasal swabs, as well as nasal aspirates, nasopharyngeal wash/aspirates, and bronchoalveolar lavage specimens from patients with suspected COVID-19, according to the firm.

Latest in Gene silencing and gene editing
Sequencing Virus Social
Gene-based technique shows potential for rapid diagnostics
March 7, 2024
Licensed under Creative Commons
Reversible, multiplex CRISPR system enhances efficacy of CAR-T cell therapy
February 28, 2024
Visit our Molecular Diagnostics Community
Sponsored
Visit our Molecular Diagnostics Community
April 5, 2024
3 D Monkeypox Infecting Cell Social
CRISPR and nanopore technology enable sensitive and specific mpox detection
February 16, 2024
Related Stories
2019 02 13 19 24 5396 Fda Logo V2 400
Emergency Use Authorization
FDA authorizes 11th over-the-counter COVID-19 test
2020 05 01 20 07 6840 Warning Circular 400
COVID-19
FDA recalls 2 SARS-CoV-2 at-home tests
2020 04 30 22 13 6857 Coronavirus Swab Ppe 400
COVID-19
FDA cautions use of immunity tests after COVID vaccination
Visit our Molecular Diagnostics Community
Sponsor Content
Visit our Molecular Diagnostics Community
More in Gene silencing and gene editing
Gene-based technique shows potential for rapid diagnostics
By LabPulse.com staff writers
Biomedical engineers have developed a new gene-based approach which can be used on test strips for rapid, on-the-spot disease detection with accuracy comparable to that of lab-based polymerase chain reaction (PCR) tests.
March 7, 2024
Sequencing Virus Social
Reversible, multiplex CRISPR system enhances efficacy of CAR-T cell therapy
By Nick Paul Taylor
A CRISPR system that uses Cas13d to make reversible changes to the expression of multiple genes could overcome limitations that are holding back CAR-T cell therapies, a paper published in Cell suggests.
February 28, 2024
Licensed under Creative Commons
Intellia Therapeutics, ReCode Therapeutics to collaborate on genomic medicines for CF
By LabPulse.com staff writers
Gene-editing firm Intellia Therapeutics and biotech company ReCode Therapeutics have entered into a strategic collaboration aimed at developing genomic medicines for the treatment of cystic fibrosis (CF).
February 16, 2024
Science Genome Sequence Dna Map Social
CRISPR and nanopore technology enable sensitive and specific mpox detection
By Nick Paul Taylor
A test that combines CRISPR gene editing and nanopore sensing technology could accelerate the detection of mpox and other pathogens, according to a paper published in Biosensors and Bioelectronics.
February 16, 2024
3 D Monkeypox Infecting Cell Social
Sensorion receives clinical trial approval for congenital deafness gene therapy
By LabPulse.com staff writers
French biotech firm Sensorion has received approval to initiate a phase I and II clinical trial in France of SENS-501 (the OTOF-GT program), its gene therapy for gene-mediated hearing impairment.
January 22, 2024
Clinical Trial Data Network Social
First FDA-approved CRISPR-based gene therapy cleared for 2nd indication
By LabPulse.com staff writers
A month after the U.S. Food and Drug Administration (FDA) approved Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Casgevy for the treatment of sickle cell disease, the agency has given it a second U.S. regulatory approval ahead of schedule.
January 17, 2024
Cell Gene Therapy Dna Social
Genevant Sciences forges $114M deal with Tome Biosciences on liver disease gene therapy
By LabPulse.com staff writers
Biotech firm Genevant Sciences will collaborate with biotech startup Tome Biosciences on an in vivo gene editing treatment for a rare liver disorder.
January 16, 2024
Dna Genetic Engineering Single Nucleotide Social
IGI, Danaher launch CRISPR gene therapy research center
By LabPulse.com staff writers
Danaher and the Innovative Genomics Institute (IGI) have launched a collaborative research center aimed at developing CRISPR-based gene therapies for a wide array of diseases.
January 12, 2024
Crispr Cas9 Gene Editing Social
Gene therapy, companion diagnostic hit milestones for hemophilia A
By Liz Carey
Six months after the FDA approved a one-time gene therapy for severe hemophilia A reportedly priced around $2.5 million per patient, the Center for Inherited Blood Disorders, a 340B treatment center in California, has announced the drug's first infusion.
January 11, 2024
Blood Cells Vessel Social
Tome Biosciences acquires Replace Therapeutics in $65M deal
By LabPulse.com staff writers
Less than a month after Tome Biosciences emerged with $213 million in funding, the gene editing company will acquire Replace Therapeutics for $65 million in upfront and near-term milestones, with a total deal value of up to $185 million.
January 5, 2024
Dna Sequence Social
KSQ Therapeutics receives FDA clearance for trial of CRISPR-Cas9 engineered tumor therapy
By LabPulse.com staff writers
Biotech firm KSQ Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a phase I and II trial of KSQ-001EX, KSQ’s CRISPR-Cas9 engineered tumor-infiltrating lymphocyte program.
November 29, 2023
Crispr Cas9 Gene Editing Social
U.K. regulators approve 'world-first' sickle-cell gene therapy
By Matt Limb
U.K. medical regulators have approved a “world-first” gene therapy that aims to cure two blood disorders: sickle cell disease and transfusion-dependent β-thalassemia. They are the first regulatory body to approve the treatment.
November 20, 2023
Sickle Cell Anemia2 Social
Page 1 of 7
Next Page