Guardant Health, Roche’s Foundation Medicine Receive FDA Companion Diagnostic Nods

Roche’s Foundation Medicine still leads Guardant Health in terms of total companion-diagnostic US FDA approvals as both companies announced new PMA supplements.

Liquid biopsy

Two rivals in the liquid biopsy space, Guardant Health and Roche's Foundation Medicine unit, received companion-diagnostic PMA supplements from the US Food and Drug Administration.

Guardant Health announced on 28 May that the FDA approved its Guardant360 CDx test as the first and only...

Welcome to Medtech Insight

Create an account to read this article

More from In Vitro Diagnostics

Waters’ Purchase Of BD Biosciences & Dx Brings Growth Potential Alongside Trade-Offs

 
• By 

Waters Corp. will acquire Becton Dickinson’s Biosciences and Diagnostics business for $17.5bn, doubling its TAM to $40B. Analysts praise the flow cytometry addition but see weaker growth in diagnostics.

Thena Capital’s New Fund Up And Running With £1M Investment In Plexāā’s Breast Cancer Device

 

Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.

Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

Dxcover Launches US Operations With New Headquarters In Tennessee

 

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

More from Diagnostics

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By 

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring

 

“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.

No Strings Attached: Big Players Chase Insulet In Fast-Growing Tubeless Insulin Pump Market

 
• By 

Medtronic, Tandem and Beta Bionics are gearing up to bring tubeless patch pumps to market, chasing Insulet’s Omnipod 5, the only FDA-cleared patch pump for type 1 and type 2 diabetes. Analysts expect tubeless models to eventually displace durable pumps.