Podcast: Thermo Fisher Talks Regulatory Experience With Oncomine

US FDA recently approved Oncomine Dx Target Test, the first multi-drug next-generation sequencing test made by Thermo Fisher Scientific. The test is a companion diagnostic for lung-cancer drugs made by Novartis and Pfizer, and the diagnostic company is looking to expand its partnership to other pharma companies.

Laboratory
Thermo Fisher's Oncomine Dx Target Test is the first multi-drug next-generation sequencing test approved by US FDA • Source: Thermo Fisher Scientific

Thermo Fisher Scientific Inc. announced last month it received US FDA approval of its Oncomine Dx Target Test, the first next-generation sequencing test approved for multiple drugs. Because of the uniqueness of the test and regulatory path it took, Medtech Insight spoke to Joydeep Goswami, president of the Clinical Sequencing Division in the firm's Life Sciences Group, to learn more.

Oncomine was developed by Thermo Fisher and used by the National Institutes of Health to study various forms of non-small...

Medtech Insight Podcast

Keep up with the top medtech business and regulatory news.

Medtech Insight brings you interviews and analysis, on the go.

More from Regulation

Digital Health Roundup: Digital Therapeutics Navigate GLP-1, Immersive Gaming; DHCoE AI Framework; Hello Heart

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

MI-PolicyAndRegulation (Free-1): Biliary Atresia Linked to Autism and Neurodevelopment Delays

 
• By 

Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

Global Medtech Guidance Tracker: September 2024

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

More from Policy & Regulation

News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

MI-PolicyAndRegulation (Free-1): Biliary Atresia Linked to Autism and Neurodevelopment Delays

 
• By 

Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

Sponsored By

Nancy Tests SPARC-931 Part 7

This is a description