Leveraging at-home molecular diagnostics opportunities requires dual focus on costs, regulations, and sustainability” says Sagentia Innovation

Medical device manufacturers looking to develop molecular diagnostic solutions for home use need to ensure that price points and regulatory matters are considered at the earliest possible stage.

This is the advice from R&D consultancy Sagentia Innovation as techniques such as next-generation sequencing unlock new opportunities in this growing market. Scientific progress, coupled with increased acceptance following COVID-19, mean the at-home diagnostics category is ripe for innovation. However, devices need to achieve low manufacturing costs while meeting stringent regulatory requirements.

Specialists at Sagentia Innovation anticipate an increase in over the counter (OTC) molecular devices to diagnose conditions ranging from respiratory illness to STIs and cancer. However, OTC products are price sensitive, and from a regulatory perspective, molecular testing is historically considered highly complex and unreliable in the hands of a layperson. While this opinion is beginning to shift, aligning regulatory strategy with product development is a critical factor in accelerating time to market.

Alongside matters related to costs and regulations, sustainability considerations are moving up the agenda. This has implications for materials selection and raises new questions surrounding the benefits of single- versus multi-use devices. 

To help medical device manufacturers navigate these opportunities and challenges, Sagentia Innovation published a free whitepaper, Making at-home molecular tests affordable, actionable and sustainable. It examines existing at-home diagnostic devices developed for COVID-19 then outlines a vision for cost reduction and sustainability. The regulatory landscape for these products is also explored.  

One of the paper’s authors, Sagentia Innovation’s CTO Nick Collier, says balancing the various requirements requires collaboration between different disciplines.

“At-home molecular diagnostic technologies have the potential to revolutionise healthcare, but a good concept is only the start, there are many factors involved in getting a new device into the hands of users such as cost, human-centred design, regulatory and many more” Collier explains. “Also, the closer we get to OTC the more important sustainability becomes and giving early consideration to materials, manufacture, reuse and disposal is essential.”

Nick Collier will be giving a talk at the forthcoming AACC Annual Scientific Meeting and Clinical Lab Expo on 26 July. The session will focus on improving sample collection for point of care and point of need testing. Find out more here. 

The whitepaper Making at-home molecular tests affordable, actionable and sustainable is available at: /insights/making-at-home-molecular-tests-affordable-actionable-and-sustainable/

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