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Diagnostics Are Essential, But How Can Companies Ensure A Fair Price?

 
• By Barnaby Pickering

Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?

Stethescope and balance sheet. Concept: Business of healthcare
(janews/Shutterstock)

It is no secret that taking an in vitro diagnostic to market is hard.

And while this year’s BIO-Europe Spring event, held in Milan in March, focused primarily on cutting edge biotech and big...

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More from Diagnostics

Philips Announces Major Investment In US Manufacturing And Expansion Of Pennsylvania Facility

 
• By Brian Bossetta

Philips says the expansion of its facility in Reedsville, PA, will not only boost its capacity to produce AI-enabled ultrasounds that are used in hospitals across the US but will also create 120 well-paying jobs.

NAD Alerts Agendia Over Endorsing Physician’s Ties To Firm

 
• By Elizabeth Orr

The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 
• By Brian Bossetta

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.

Exact Sciences Reveals Thinking On CRC Liquid Biopsy After Freenome Deal

 
• By Natasha Barrow

Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.

More from Market Access

NICE’s Rules-Based Pathway And Innovator Passports Get Go-Ahead In UK NHS 10-Year Plan

 
• By Ashley Yeo

The NHS 10-Year Plan officially released on July 3 will crystalize NICE’s Rules-Based Pathway – a new concept for medtech evaluation that will come with a guarantee of funding – but only for a select number of products. Government to also introduce “innovator passport” to speed innovation into NHS.

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 
• By Francesca Bruce

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

SS Innovations’ SSI Mantra 3 Poised To Challenge Da Vinci In Robotic Surgery Market

 
• By Marion Webb

SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.