Information for participants, clinicians
and collaborators

Biosignatures' technology has the potential to replace biopsies for cancer diagnosis with blood tests. Thank you for helping us to make this happen!

Participants in clinical trials

If you are participating in one of the studies Biosignatures is carrying out, thank you!

Biosignatures has developed a patented software system which it is using to create new diagnostic tests from the analysis of patient blood samples.

We simply could not do this without the expertise and skill of our clinical collaborators and the selfless support of patients.

Study Status

Biosignatures are currently working with clinical partners on a range of research projects.

BiopSave Clinical Validation Trial, Freeman Hospital, Newcastle

This study is a blinded, prospective, non-randomised observational controlled study to validate the clinical performance of the BiopSave novel proteomic blood test for the diagnosis of prostate cancer. It compares the ability of the BiopSave assay to predict a biopsy-derived diagnosis of prostate cancer with that of current practice, which is based upon prostate specific antigen (PSA) level.

The results have come in from phase one, and it’s a success!
The product demonstrated it is 4X more effective than PSA and 56% better than the leading next generation competitor. We expect to have the results from Phase 2 in 2019.

Urology validation study, Sunderland Royal Hospital, Sunderland

This study is now complete. Samples have been collected and used internally to test the performance of the prostate, bladder and renal signatures. Currently there are no results to report externally.

Urology discovery study, Freeman Hospital, Newcastle

This study is successfully complete. Three products have been discovered during the study in prostate, bladder and renal cancer. The prostate product is being tested as described above.

If you would like to find out further information regarding the BiopSave assay or access to the patient information sheet, please contact us.

Current Collaborations

freeman-hospital-photograph-clinical-page

Urology Department, Freeman Hospital, Newcastle upon Tyne

The team at the Freeman, lead by Mr Naeem Soomro and Mr Rakesh Heer are the lead clinical partners on the urology projects.
Urology Department
Mr. Naeem Soomro
Mr Rakesh Heer

sunderland-royal-clinical-page

Sunderland Royal Hospital

The team at Sunderland have led cross-site validation, carried out as part of the urology project.
Sunderland Royal Hospital

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Newcastle University

Craig Robson, Professor of Molecular Urology at Newcastle University is responsible for the blinding of the BiopSave Clinical Validation Trial
Newcastle University
Professor Craig Robson

Future Collaborations

The company is currently involved in a major fundraising exercise and once this is complete will be looking to run multiple discovery projects and validation trials in sites in both the UK and the USA.
Biosignatures are therefore very interested in hearing from clinicians who have an interest in developing and validating new diagnostic and prognostic tools.

For example, in breast cancer a study is currently in the planning stage. Its objective is to discover novel biomarkers of breast cancer to enable invasive and time-consuming assays such as biopsies to be targeted towards women who are most likely to benefit from them.

Previous Collaborations

AstraZeneca

In collaboration with AstraZeneca, Biosignatures' then parent company, Nonlinear Dynamics published the first study showing that gel-based proteomics combined with advanced software could reliably analyse human blood samples: Jackson, D. et al.(2009), Prot. Clin. Appl., 3: 394–407.
www.astrazeneca.co.uk

Novartis Institutes for BioMedical Research (NIBR)

With NIBR, Biosignatures ran a double blind trial of the Tiger discovery technology. In this trial, the technology was able to identify the mode of action of antibiotics with 100% accuracy.
www.nibr.com

HUPO

Working with some of the best laboratories in the field of proteomics and alongside NIBR, Biosignatures' then parent company, Nonlinear Dynamics ran the HUPO reproducibility study which proved for the first time 2D gels could generate data that was reproducible cross-lab.
www.hupo.org

Bio-Rad

Working with Bio-Rad, Biosignatures' then parent company, Nonlinear Dynamics led a follow-on reproducibility study which demonstrated how to use standards to enable labs to reproduce each other's work.
www.bio-rad.com

ANY QUESTIONS

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