Optimizing Gene Therapy: The Importance Of Companion Diagnostics

As the US Food and Drug Administration now requires companion assays for certain gene therapy products, companies should be aware of the intricacies of developing an accurate test. 

Gene therapy

Gene therapy offers the possibility of new cures, particularly for rare diseases with a genetic basis. As such, it has sparked great interest among researchers, health care providers and patients alike. However, the ideal methods and solutions to unlock the full potential of gene therapies are still being developed.

In recent years, the US Food and Drug Administration has required gene therapy companies to develop tests to screen patients...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo 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

More from Innovation

Trojan Bio Eyes Perfect Rainbow Shot With Immune System Cancer Innovations

 
• By 

Trojan Bio’s proprietary platform, based on engineered antibodies that activate the immune system to fight cancer in the same way as common viral infections, won Biomed Israel's 2025 biopharma start-up award. CEO and cofounder Anat Burkovitz said the technology is attracting investors' attention.

Podcast: Oxolife’s Agnés Arbat, Winner Of The European Prize For Women Innovators

 
• By 

Agnès Arbat, CEO of Oxolife and winner of the EU Women Innovators Prize, joins In Vivo to discuss OXO-001, a novel non-hormonal treatment aimed at improving embryo implantation in IVF. She shares insights from her biotech journey and the future of fertility innovation.

AI In Biologics Discovery: The Expensive Bet On Unproven Promise

 
• By 

Despite limited evidence of commercial impact, pharmaceutical companies are making massive strategic investments in AI biologics platforms. The question isn't whether the technology shows promise; it's whether that promise can translate to measurable business results.

Podcast: Acuitas CSO On CRISPR Delivery Breakthrough And Next-Gen Lipid Nanoparticle Technology

 
• By 

In Vivo sits down with Ying Tam, CSO at Acuitas Therapeutics, to discuss the company's role in delivering the first personalized CRISPR treatment to an infant and the clinical implications of new lipid nanoparticle technologies.

More from In Vivo

Execs On The Move: June 2025

 
• By 

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

AI In Biologics Discovery: The Expensive Bet On Unproven Promise

 
• By 

Despite limited evidence of commercial impact, pharmaceutical companies are making massive strategic investments in AI biologics platforms. The question isn't whether the technology shows promise; it's whether that promise can translate to measurable business results.

Kris Joshi Named Norstella CEO, Prioritizes AI Innovation

 
• By 

Joshi joins the parent company of Citeline, which houses flagship publications In Vivo, Scrip and Pink Sheet, to focus on AI, business harmonization and long-term growth.