Clinical validation of a spectroscopic liquid biopsy for earlier detection of brain cancer

Author:

Cameron James M1ORCID,Brennan Paul M2,Antoniou Georgios1,Butler Holly J1,Christie Loren1,Conn Justin J A1,Curran Tom3,Gray Ewan4,Hegarty Mark G1,Jenkinson Michael D5,Orringer Daniel6,Palmer David S17,Sala Alexandra17,Smith Benjamin R1,Baker Matthew J1

Affiliation:

1. Dxcover Ltd. (formerly known as ClinSpec Diagnostics Ltd.), Glasgow, UK

2. Translational Neurosurgery, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK

3. Children’s Mercy Research Institute at the Children’s Mercy Hospital, Kansas City, Kansas, USA

4. Independent Health Economics Consultant, Edinburgh, UK

5. Institute of Translational Medicine, University of Liverpool & The Walton Centre NHS Foundation Trust, Liverpool, UK

6. Department of Neurosurgery, New York University Grossman School of Medicine, New York, New York, USA

7. Department of Pure and Applied Chemistry, University of Strathclyde, Glasgow, UK

Abstract

Abstract Background Diagnostic delays impact the quality of life and survival of patients with brain tumors. Earlier and expeditious diagnoses in these patients are crucial to reduce the morbidities and mortalities associated with brain tumors. A simple, rapid blood test that can be administered easily in a primary care setting to efficiently identify symptomatic patients who are most likely to have a brain tumor would enable quicker referral to brain imaging for those who need it most. Methods Blood serum samples from 603 patients were prospectively collected and analyzed. Patients either had non-specific symptoms that could be indicative of a brain tumor on presentation to the Emergency Department, or a new brain tumor diagnosis and referral to the neurosurgical unit, NHS Lothian, Scotland. Patient blood serum samples were analyzed using the Dxcover® Brain Cancer liquid biopsy. This technology utilizes infrared spectroscopy combined with a diagnostic algorithm to predict the presence of intracranial disease. Results Our liquid biopsy approach reported an area under the receiver operating characteristic curve of 0.8. The sensitivity-tuned model achieves a 96% sensitivity with 45% specificity (NPV 99.3%) and identified 100% of glioblastoma multiforme patients. When tuned for a higher specificity, the model yields a sensitivity of 47% with 90% specificity (PPV 28.4%). Conclusions This simple, non-invasive blood test facilitates the triage and radiographic diagnosis of brain tumor patients while providing reassurance to healthy patients. Minimizing time to diagnosis would facilitate the identification of brain tumor patients at an earlier stage, enabling more effective, less morbid surgical and adjuvant care.

Funder

Scottish Enterprise High Growth Spinout Program

Innovate UK Precision Medicine Accelerator Grant

Publisher

Oxford University Press (OUP)

Subject

Electrical and Electronic Engineering,Building and Construction

Reference46 articles.

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2. Cancer Statistics, 2021;Siegel;CA A Cancer J Clin.,2021

3. Clinical features of primary brain tumours: a case–control study using electronic primary care records;Hamilton;Br J Gen Pract.,2007

4. Symptoms in primary care with time to diagnosis of brain tumours;Ozawa;Fam Pract.,2018

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