1. Medtech Insight
  2. >>Business

First Test That Can Detect COVID-19 Virus Mutations Authorized By FDA

The US FDA on 10 June authorized use of Illumina’s COVIDSeq next generation sequencing diagnostic test to detect the SARS-CoV-2 virus and figure out if it’s mutating. The agency has high hopes this first-of-its-kind test will give researchers a better picture in the ongoing global fight against the COVID-19 pandemic.

Virus and mutations process 3d illustartion. New virus mutation of coronavirus, hantavirus, COVID-19, pandemic concept background for health, medical design. Coronavirus mutation 3d rendering.
The FDA is optimistic Illumina’s COVIDSeq NGS test can help researchers understand potential mutations of the SARS-COV-2 virus, as illustrated

Illumina Inc.'s COVIDSeq is the first next-generation sequencing (NGS) diagnostic test to be given emergency use authorization by the Food and Drug Administration. The head of the US agency says the test will allow physicians to diagnose whether a patient has the SARS-CoV-2 virus and let researchers track whether it’s mutating.

The FDA said on 10 June it had granted authorization for the COVIDSeq diagnostic test as the first of its...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Business

More from Medtech Insight

Execs On The Move: June 16–20, 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Dxcover Launches US Operations With New Headquarters In Tennessee

 
• By Natasha Barrow

Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.

EnsoData Boosts AI Sleep Tech With $20M Series B Funding, Targets Underdiagnosis Crisis

 
• By Shubham Singh

EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.