27 September 2019

Why is Companion Diagnostics Making Worldwide Personalised Healthcare a Reality?

By Ben Paice

Precision medicine is exciting everyone in healthcare. 

This proactive approach personalises treatment for patients based on their predicted response to certain diseases and treatments.

Companion diagnostics are supporting this space with collaborations between diagnostic and pharmaceutical companies, producing top-of-the-range drugs that are tailored per assay to offer truly personalised treatment.

There are countless benefits to companion diagnostics including better evidence of clinical utility & greater patient access, more efficient use of resources, better safety and economic advantages for drug companies.

Thanks to these advantages, the companion diagnostics market is growing rapidly. By 2022, it’s expected to be worth $6.5bn with a CAGR of 20.1%.

For now, North America remains the home of companion diagnostics and dominates the market share, providing some of the most influential collaborations in the space.

LabCorp, based in North Carolina, boasts one of the largest clinical laboratory networks in the world. Networks like LabCorp’s are crucial to advancing the companion diagnostics space, with their collaborations able to improve treatments for a greater number of patients.

LabCorp’s involvement in the Qiagen Day-One program is possibly one of the most significant partnerships right now in companion diagnostics, considering the many resources at the disposal of each company.

The program ensures that LabCorp’s therapies are accessible from day-one of approval. This is achieved through Qiagen’s rigorous pre-approval preparation of workflow implementation, training, assay verification, forecasting and medical communication.

The program includes tests based on next-generation sequencing (NGS) and quantitative polymerase chain reaction (qPCR). Assays for multiple indications, including novel companion diagnostics for several cancers, are currently in LabCorp’s lab readiness pipeline for the program.

Programs of this scale have a big impact, improving access to personalised treatments for many patients. However, they require an abundance of resources and are only a viable option for huge corporations like Qiagen, Labcorp and other global powerhouses.

Companies with more limited resources, contributing to companion diagnostics, tend to have more of a focus on innovation and technology.

Looking away from the US, Belgium molecular diagnostics company, Biocartis, offer one of the most exciting technologies contributing to companion diagnostics. Their Idylla platform enables clinical laboratories to perform a broad range of tests focusing on oncology.

This unique and affordable rapid molecular diagnostic platform combines short turnaround times with strong performance. Its ability to quickly provide more accurate and reliable results provides patients with speedier and more personalised treatments.

Although there’s diagnostics technology with similar advantages on the market, like Cepheid’s Gene Expert range, the Idylla platform specialises in oncology – the area where companion diagnostics is advancing most – making it vital to the space.

Thanks to the platform’s qualities, Biocartis has secured partnerships with top pharmaceutical organisations like Bristol-Myers SquibbMerck and LabCorp's Drug Development business, Covance. Such partnerships mean that patients around the world are benefiting from more accurate and personalised treatment. 

As well as Europe and the US, companion diagnostics is growing rapidly in the APAC region with a 17% CAGR. This rapid growth is thanks to public and private initiatives to increase adoption of companion diagnostics devices (CDx), notably within countries such as China and Australia.

With growth across the board and the market on the up, innovation has been rife.

Most notably, we’ve seen liquid biopsy CDxs become commercially available – like Invivoscribe’s Leukostrat CDx FLT3 Mutation Assay used as the CDx for Daiichi Sankyo’s Quizartinib Leukemia patients. Advantageous for spotting early stages of cancer and their non-invasive properties, liquid biopsies are likely to be the next ‘big thing’ to be offered globally as a companion diagnostic cancer treatment.

While this advancement in oncology is important, we are also seeing exciting steps being taken away from cancer treatments. Many companion diagnostic collaborations are now delving into the world of pathology and infectious disease. This is something that we’re likely to see increase in popularity as the market expands and personalised healthcare advances. 

This is all exciting, but let’s not get ahead of ourselves. There’s still a long way to go and much more to come from companion diagnostics. However, if worldwide personalised healthcare does become a reality, advancements in this space will be crucial.

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By Ben Paice

Ben Paice is a Business Manager, leading a team of diagnostic specialists with a global focus. He specialises specifically in molecular diagnostics and today is responsible for handling some of Charlton Morris’ most important accounts.

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