Ventana to help develop pathway for companion diagnostics

By Dr Matt Wilkinson

- Last updated on GMT

Related tags: Dna, Genetics

The Critical Path Institute (C-Path) and diagnostics expert Ventana
Medical Systems are collaborating to develop a standard submission
route for targeted therapies and companion diagnostics.

The collaboration, funded by the Science Foundation Arizona (SFAz) to the tune of $2.1m (€1.5m), will try to establish the performance standards that would serve as a model for co-submissions of both a targeted therapeutic and its related diagnostic test to the regulators. With the advent of highly targeted therapies, such as Roche/Genentech's Herceptin (trastuzumab) for HER-2 expressing cancers, the need for in vitro​ diagnostics (IVD) kits has become increasingly important. Indeed, such is Roche's belief in the benefit of companion diagnostics it has been trying to takeover Ventana with a $3bn hostile bid​ that was launched three months ago. However, there is currently no proven co-development pathway to gain US Food and Drug Administration (FDA) approval of these necessary diagnostic kits along with their associated therapies, with each having to be approved separately. A recent market research report, published by Espicom Business Intelligence, has estimated the global market for in vitro​ diagnostics was worth $34bn in 2007. The report also estimates that around 60 per cent of all clinical decisions are influenced by a diagnostic test making the lack of a clear pathway for companion diagnostics all the more surprising. To make matters worse, the biomarkers that indicate whether a patient will benefit from a drug or not are often not discovered until during the clinical trial process making the development of a diagnostic ahead of the drug impossible. This can lead to severe delays during the approval process as the diagnostic needs to be developed and approved so that patient stratification using the diagnostic can occur during later clinical trials. Founded by the FDA, C-Path's raison d'etre​ is to create collaborative projects to enable the safe acceleration both of medicinal products and the processes they go through to gain approval. As such they will work closely with both the US National Cancer Institute (NCI) and the FDA to develop a clear pathway that will reduce the time taken to get a drug and its diagnostic test through the regulatory process and so get them to market quicker. Once devised, the collaborators will apply these standards to Ventana's companion diagnostic for a lung cancer therapy that is currently going through the approval process. "Ventana's collaboration with C-Path furthers our commitment to personalised medicine and our view that companion diagnostics will increasingly become a key factor in the development and administration of many new cancer therapies,"​ said Christopher Gleeson, CEO of Ventana. The need for more personalised medicines has been emphasised by recent research using Applied Biosystems' new SOLiDgene sequencing instrument​ showing that there is as much as five times the genetic variation between two individuals than previously estimated. The research, published in the latest issue of PLoS Biology​, studied the sequences of the first diploid human genome. The majority of these genetic differences are represented by changes in single bases, known as single nucleotide polymorphisms (SNPs). The latest study identified more than 1.2m unknown SNPs and structural variants. "We recognise the paradigm shift created by the PLoS Biology study and believe that technical advancements made to the SOLiD platform uniquely position it to address the increased genetic variation in the human genome,"​ said Dr Kevin McKernan, on the inventors of Applied Biosystems' next generation SOLiD DNA sequencing platform. "We expect that the advancements to the throughput, accuracy, and scalability of the SOLiD System will enable researchers to make more meaningful associations between genetic variation and medical conditions. This is expected to be crucial in the emerging era of personalised medicine."

Related topics: Preclinical Research

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