About Biosignatures

Diagnostic discovery for non-invasive, patient friendly and accurate disease diagnosis

Disease diagnostics

Biosignatures was established in 2007 to address a global need for non-invasive, patient friendly and accurate disease diagnosis.

The company has developed a portfolio of products and has a growing body of evidence demonstrating their performance in blind tests. All the products under development are intended to bring significant improvements to current clinical best-practice. The goal is to enhance the experience of patients and reduce costs to healthcare providers through the replacement of complex, invasive and time-consuming biopsies with the analysis of small-volume blood samples.

Biosignatures uses proteomics (specifically the separation and analysis of proteins within blood samples) to identify patterns of proteins (or biosignatures) specific to a disease using statistical methods. It considers itself to be the first organisation in the world with the capability to reliably and cost effectively find new and highly valuable disease diagnostics using proteomics.

The company currently has one product in the clinic, BiopSave which has just passed it's first independently blinded clinical trial. The company also has three products in pre-clinical development, with a focus on prostate, bladder and renal cancers.

Unique Capability

Biosignatures’ unique capability to systematically and reliably discover new commercially viable diagnostics is driven by our deep understanding of the discovery process:

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Application of these principles allows Biosignatures to avoid the pitfalls which have made it surprisingly difficult to make advances in this area despite billions of dollars of investments.

How does Biosignatures do this?

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To find a new diagnostic, first we collect hundreds of blood samples from patients as they present at the clinic. We process the samples using our multiple protein monitoring system, then feed the data into the Tiger analytical software, which identifies those proteins that can be used to predict disease state. The whole process is controlled by the Work Packet System procedures and runs under our ISO 13485 Quality System.

Whilst the initial focus is on diagnostics for urological cancers, the technology platform will be applied across a wide range of diseases.

Building on its deep understanding of the underlying scientific issues in diagnostic discovery Biosignatures has created a technology platform with three main components.

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The Work Packet System - Industry leading standard operating procedures across clinical study design, patient recruitment, clinical sample tracking, data capture, sample biobanking, reporting and informatics.

Multiple Protein Monitoring -
A reliable proteomic processing system for the identification of diagnostic signatures by separating the proteins in blood samples and measuring them using an imager.

The patented Tiger statistical software - Developed over more than 10 years by the former research team of Nonlinear Dynamics. This software represents a breakthrough in the analysis of large proteomic datasets.

How Biosignatures Works

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Management Team

The team has worked together since 2003 and in addition to negotiating, executing and managing licensing agreements with global businesses such as GE Healthcare, Waters Inc. & AstraZeneca, the team members built and sold Nonlinear Dynamics (a company specialising in image analysis and statistics for application to proteomics) to Waters Inc. in 2013.

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Will Dracup, CEO - over 25 years’ experience in commercial life sciences and computing. He founded Nonlinear Dynamics in 1989, created the initial products and led the business through to its sale to Waters Inc. in 2013. He was also a non-Executive Director of IDS PLC, an AIM-listed diagnostics business, for 5 years.

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Dr David Bramwell, CTO - 20 years’ experience in commercial life sciences and IT. He has a 1st class M.Eng (hons) and a PhD in human visual perception. He joined Nonlinear Dynamics in 2000, led its software development from 2002 and has been responsible for the key insights behind Biosignatures’ technology.

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Keith Milton, CFO – over 25 years’ experience in finance, holding CFO positions across a variety of sectors including computer software. Keith also has experience taking two businesses through to multi-million pound exits. Keith has signed an employment contract with Biosignatures and will start in January 2017.

Commercialisation

Market overview for the BiopSave product

The global In-Vitro Diagnostics market is predicted to be worth c.$70 billion per annum by 2017. Within this market, Biosignatures operates at the intersection of two fast growing sub-sectors – molecular diagnostics and proteomics.

It is estimated that around 100,000 prostate biopsies are performed per annum in the UK, and in excess of 1 million per annum in the US. The number of prostate cancers actually diagnosed each year is, however, much smaller at around 40,000 per year in the UK and around 240,000 per year in the US.

A significant number of prostate biopsies could be safely avoided by using the BiopSave test, representing a significant cost benefit in addition to improved patient well being.

Revenue model

Biosignatures will work with leading players in the diagnostics market using an industry-recognised commercial licensing model which the team has experience of managing. Each biosignature will be licensed as IP to a large diagnostic partner, who will develop a diagnostic test which uses the partner's proprietary hardware platform. Targeted partners will typically have these systems installed in hospitals worldwide.

Company History

Biosignatures started life in 2007 when it spun out of Nonlinear Dynamics Ltd.

ANY QUESTIONS

Feel free to get in touch about any aspect of Biosignatures and our range of products.