Diagnostics
Examples of diagnostics projects previously funded by Technology Transfer. See other areas.
Strategic Translation Award
An automated blood based assay-system for monitoring tumour load in a routine diagnostic setting
Cancer is caused by the accumulation of genetic damage (mutations) in cells within a particular organ. These mutations are only found in the cancerous cells, and therefore could be used to monitor the tumour load during treatment, and rapidly evaluate treatment response.
This could potentially allow patients' treatment to be personalised, through making individual decisions on treatment duration and intensity. Ultimately, this could allow drugs to be targeted to only those patients who show meaningful response, reducing unnecessary side-effects and improving effectiveness. Advances in DNA sequencing allow the high-throughput identification of these mutations from any tumour tissue in a clinically relevant time-frame. As tumour cells die, they release their DNA into the bloodstream. The new generation of genetic sequencing technologies can identify a particular class of mutations caused by the abnormal rearrangement of chromosomes in patients with cancer. From these rearrangements, personalized tests can be developed for each patient to detect tumour DNA that has been released into the bloodstream. Such tests are highly specific and sensitive, being able to isolate and detect just one molecule of tumour DNA in many millilitres of blood. To implement such tests in a real-world healthcare system requires development of new instruments and technology. Dr Patrick van den Bogaard at Biocartis SA, in collaboration with researchers at the Wellcome Trust Sanger Institute and at Philips Research, are developing a novel diagnostic platform which will automate a blood-based assay for monitoring tumour load in the patient’s own hospital. The system will use disposable, microfluidic cartridges with digitally encoded micro particles for the rapid and sensitive detection of multiple DNA samples. The availability of this test is expected to have a major impact on personalising treatment of tumours, increasing the quality of clinical care and the quality of life for the patient.
This could potentially allow patients' treatment to be personalised, through making individual decisions on treatment duration and intensity. Ultimately, this could allow drugs to be targeted to only those patients who show meaningful response, reducing unnecessary side-effects and improving effectiveness. Advances in DNA sequencing allow the high-throughput identification of these mutations from any tumour tissue in a clinically relevant time-frame. As tumour cells die, they release their DNA into the bloodstream. The new generation of genetic sequencing technologies can identify a particular class of mutations caused by the abnormal rearrangement of chromosomes in patients with cancer. From these rearrangements, personalized tests can be developed for each patient to detect tumour DNA that has been released into the bloodstream. Such tests are highly specific and sensitive, being able to isolate and detect just one molecule of tumour DNA in many millilitres of blood. To implement such tests in a real-world healthcare system requires development of new instruments and technology. Dr Patrick van den Bogaard at Biocartis SA, in collaboration with researchers at the Wellcome Trust Sanger Institute and at Philips Research, are developing a novel diagnostic platform which will automate a blood-based assay for monitoring tumour load in the patient’s own hospital. The system will use disposable, microfluidic cartridges with digitally encoded micro particles for the rapid and sensitive detection of multiple DNA samples. The availability of this test is expected to have a major impact on personalising treatment of tumours, increasing the quality of clinical care and the quality of life for the patient.
Strategic Translation Award
Rapid diagnostics tests for resource-poor settings
Inexpensive, simple and high-performance tests for the simultaneous detection of hepatitis B virus (HBV), human immunodeficiency virus (HIV) and hepatitis C virus (HCV) for use in resource-limited settings.
From a product development partnership between Diagnostics for the Real World Limited and Dr Helen Lee, University of Cambridge Diagnostic Development Unit, these tests will be particularly applicable to clinical settings in which a rapid and immediate test result is crucial.
From a product development partnership between Diagnostics for the Real World Limited and Dr Helen Lee, University of Cambridge Diagnostic Development Unit, these tests will be particularly applicable to clinical settings in which a rapid and immediate test result is crucial.
Strategic Translation Award
Clinical trial of a Chlamydia trachomatis rapid test
Chlamydia trachomatis infections are one of the most common bacterial sexually transmitted diseases in the world. If detected early, the disease is very easy to treat with a one-off antibiotic pill.
However, undetected and untreated infections can lead to infertility, ectopic pregnancy and pelvic inflammatory disease. Efforts to control chlamydia are hampered by the fact that the majority of infected individuals are asymptomatic. In addition, sensitive methods to detect the infection are technically complicated, time consuming and expensive. Dr Helen Lee and Diagnostics for the Real World (DRW) have developed a rapid diagnostic test, the Chlamydia Rapid Test, and FirstBurst Urine Collector. These developments together provide a 30-minute diagnostic test kit for chlamydia infection. The test procedure requires minimal instrumentation and can be carried out by individuals with basic training. The FirstBurst Urine Collector is a convenient, disposable device for collecting first-void urine that will be useful not only for improved sensitivity of detection of chlamydia but also with other STDs. The clinical trial will enable DRW to apply for regulatory approval of these products in the EU and US, allowing market entry in Europe and the US and enabling the availability of a high-quality product for developing countries.See our video: Developing the Chlamydia Rapid Test
However, undetected and untreated infections can lead to infertility, ectopic pregnancy and pelvic inflammatory disease. Efforts to control chlamydia are hampered by the fact that the majority of infected individuals are asymptomatic. In addition, sensitive methods to detect the infection are technically complicated, time consuming and expensive. Dr Helen Lee and Diagnostics for the Real World (DRW) have developed a rapid diagnostic test, the Chlamydia Rapid Test, and FirstBurst Urine Collector. These developments together provide a 30-minute diagnostic test kit for chlamydia infection. The test procedure requires minimal instrumentation and can be carried out by individuals with basic training. The FirstBurst Urine Collector is a convenient, disposable device for collecting first-void urine that will be useful not only for improved sensitivity of detection of chlamydia but also with other STDs. The clinical trial will enable DRW to apply for regulatory approval of these products in the EU and US, allowing market entry in Europe and the US and enabling the availability of a high-quality product for developing countries.See our video: Developing the Chlamydia Rapid Test
Strategic Translation Award
Rapid and selective detection of Mycobacterium tuberculosis
Dr Geraint Morgan and Professor Colin Pillinger and Dr Liz Corbett have been awarded funds to develop a technology originally developed for space exploration.
The research aims to show how using a mass spectrometer and a sample of sputum can produce a fast, sensitive and accurate diagnosis for pulmonary tuberculosis. Together with clinical partners, the objective is to develop a deployable, automatic device for use in developing countries where resources are poor. This will be done by building on the technological developments from the Beagle 2 and Rosetta space missions and an existing Wellcome Trust grant. Sampling methods will be developed and optimised for the analysis system focusing on the needs of the end-user. It is also proposed to trial this device in the field, in Zimbabwe, to provide statistical proof of its effectiveness and allow evaluation of its performance against existing diagnostic methods.
The research aims to show how using a mass spectrometer and a sample of sputum can produce a fast, sensitive and accurate diagnosis for pulmonary tuberculosis. Together with clinical partners, the objective is to develop a deployable, automatic device for use in developing countries where resources are poor. This will be done by building on the technological developments from the Beagle 2 and Rosetta space missions and an existing Wellcome Trust grant. Sampling methods will be developed and optimised for the analysis system focusing on the needs of the end-user. It is also proposed to trial this device in the field, in Zimbabwe, to provide statistical proof of its effectiveness and allow evaluation of its performance against existing diagnostic methods.
Translation Award
In-vivo testing of a novel rapid response intravascular fibre optic oxygen tension sensor to detect Cyclical Atelectasis and direct ventilator therapy in Acute Respiratory Distress Syndrome In the 'sick lung' which afflicts many critically ill patients on the Intensive Care Unit, air sacs (alveoli) can begin to collapse in expiration and snap open again in inspiration. This cycle repeats itself with every breath and is known as cyclical atelectasis.
Mechanical ventilation of the lungs exacerbates this process and can cause further mechanical lung damage, and this can induce an inflammatory reaction which affects and damages other body organs. The mortality from ARDS is 30-50%. It is well established that prevention of cyclical atelectasis, by manipulation of the way in which ventilation is delivered, is beneficial to patients. The problem is that clinicians have no reliable and direct means of knowing when the process is occurring or if it is responding to therapy.Researchers in Oxford lead by Dr Andrew Farmery and Professor Clive Hahn believe that the presence of 'oxygen oscillations' (breath by breath variations in the pressure of oxygen) in arterial blood can be used to detect the occurrence of cyclical atelactasis in the lung. Clinicians may therefore potentially use such a signal to adjust the ventilator settings guided by the amplitude of the oscillations thus minimising the atelactasis and mitigating the cascade of deleterious effects. The research team will develop a rapid-response oxygen sensor that will measure these oxygen oscillations in real time.
In-vivo testing of a novel rapid response intravascular fibre optic oxygen tension sensor to detect Cyclical Atelectasis and direct ventilator therapy in Acute Respiratory Distress Syndrome In the 'sick lung' which afflicts many critically ill patients on the Intensive Care Unit, air sacs (alveoli) can begin to collapse in expiration and snap open again in inspiration. This cycle repeats itself with every breath and is known as cyclical atelectasis.
Mechanical ventilation of the lungs exacerbates this process and can cause further mechanical lung damage, and this can induce an inflammatory reaction which affects and damages other body organs. The mortality from ARDS is 30-50%. It is well established that prevention of cyclical atelectasis, by manipulation of the way in which ventilation is delivered, is beneficial to patients. The problem is that clinicians have no reliable and direct means of knowing when the process is occurring or if it is responding to therapy.Researchers in Oxford lead by Dr Andrew Farmery and Professor Clive Hahn believe that the presence of 'oxygen oscillations' (breath by breath variations in the pressure of oxygen) in arterial blood can be used to detect the occurrence of cyclical atelactasis in the lung. Clinicians may therefore potentially use such a signal to adjust the ventilator settings guided by the amplitude of the oscillations thus minimising the atelactasis and mitigating the cascade of deleterious effects. The research team will develop a rapid-response oxygen sensor that will measure these oxygen oscillations in real time.
Translation Award
Diarrhoea diagnostic device: from bench to bedside
C. difficile infection is the most common infectious cause of health-care associated diarrhoea and classically, is a consequence of administering an antimicrobial to a patient in a healthcare setting (hospitals, nursing facilities, long term care and rehabilitation institutions).
The frequency, severity and refractoriness of C. difficile associated diarrhoea has increased dramatically in recent years and healthcare institutions actively tackle outbreaks. Following diagnosis of C. difficile, a set of infection control measures is rapidly implemented in order to reduce morbidity and mortality and reduce the spread of the infection. Delays in intervention have adverse clinical effects and therefore timely diagnosis is crucial. C. difficile infection can be diagnosed by analysis of gases from stool of an infected patient. In collaboration with Professor Norman Ratcliffe (the University of the West of England, Bristol), Dr Chris Probert (University of Bristol) has designed a programme to develop a point-of-care reagent-free device which can in as little as 15 minutes analyse a stool sample to determine the presence or absence of C. difficile with high degree of sensitivity and specificity. Application of this device in the healthcare setting will improve patient care by allowing earlier intervention in order to reduce morbidity and mortality and prevent outbreaks.
The frequency, severity and refractoriness of C. difficile associated diarrhoea has increased dramatically in recent years and healthcare institutions actively tackle outbreaks. Following diagnosis of C. difficile, a set of infection control measures is rapidly implemented in order to reduce morbidity and mortality and reduce the spread of the infection. Delays in intervention have adverse clinical effects and therefore timely diagnosis is crucial. C. difficile infection can be diagnosed by analysis of gases from stool of an infected patient. In collaboration with Professor Norman Ratcliffe (the University of the West of England, Bristol), Dr Chris Probert (University of Bristol) has designed a programme to develop a point-of-care reagent-free device which can in as little as 15 minutes analyse a stool sample to determine the presence or absence of C. difficile with high degree of sensitivity and specificity. Application of this device in the healthcare setting will improve patient care by allowing earlier intervention in order to reduce morbidity and mortality and prevent outbreaks.
Translation Award
Velox diagnostic test for equine strangles
Strangles, caused by infection with the bacterium Streptococcus equi, is the most feared and frequently diagnosed infectious disease of horses world-wide.
The disease is characterised by abscessation of the lymph nodes of the head and neck, the swelling of which can restrict the airway. During outbreaks, up to 100 percent of horses may be affected and the disease can be fatal in up to 10 per cent of cases. Key to reducing disease spread and suffering is the rapid identification and isolation of infected horses.The current laboratory-based PCR method of disease identification developed by the Animal Health Trust (AHT) suffers from a 72 hour turnaround, during which the bacterium may have spread to other animals, exacerbating the problem. Andrew Waller and colleagues at AHT have been awarded translational funding to combine this method with the Atlas Genetics platform technology to develop a rapid point-of-care test that will enable veterinarians to diagnose the disease within 30 minutes of taking a sample from a horse. Reducing the time to identification of infected horses will deliver maximum healthcare benefit and improved clinical outcome.
The disease is characterised by abscessation of the lymph nodes of the head and neck, the swelling of which can restrict the airway. During outbreaks, up to 100 percent of horses may be affected and the disease can be fatal in up to 10 per cent of cases. Key to reducing disease spread and suffering is the rapid identification and isolation of infected horses.The current laboratory-based PCR method of disease identification developed by the Animal Health Trust (AHT) suffers from a 72 hour turnaround, during which the bacterium may have spread to other animals, exacerbating the problem. Andrew Waller and colleagues at AHT have been awarded translational funding to combine this method with the Atlas Genetics platform technology to develop a rapid point-of-care test that will enable veterinarians to diagnose the disease within 30 minutes of taking a sample from a horse. Reducing the time to identification of infected horses will deliver maximum healthcare benefit and improved clinical outcome.
Translation Award
Metabolite biomarker-based screening test to predict pre-eclampsia
Pre-eclampsia is a serious disorder of pregnancy, which affects approximately 3 per cent of pregnant women and is associated with significant maternal and perinatal morbidity and mortality.
Currently, there is no clinically useful screening method to accurately predict which mothers will develop pre-eclampsia. Consequently limited healthcare resources are thinly spread and cannot be directed towards monitoring those women at greatest risk. Moreover, currently available and emerging disease prevention strategies cannot be targeted to high-risk women most likely to benefit. Dr Louise Kenny from University College Cork and Professor Phil Baker from the University of Manchester have received Translation Award support to identify biomarkers in the plasma of women who subsequently develop pre-eclampsia. They will then test the performance of these candidate biomarkers in a large cohort of pregnant women (n=3000) akin to the normal antenatal population and develop a diagnostic which can be used to test for pre-eclampsia in widespread screening.
Currently, there is no clinically useful screening method to accurately predict which mothers will develop pre-eclampsia. Consequently limited healthcare resources are thinly spread and cannot be directed towards monitoring those women at greatest risk. Moreover, currently available and emerging disease prevention strategies cannot be targeted to high-risk women most likely to benefit. Dr Louise Kenny from University College Cork and Professor Phil Baker from the University of Manchester have received Translation Award support to identify biomarkers in the plasma of women who subsequently develop pre-eclampsia. They will then test the performance of these candidate biomarkers in a large cohort of pregnant women (n=3000) akin to the normal antenatal population and develop a diagnostic which can be used to test for pre-eclampsia in widespread screening.
Translation Award
Preclinical development of a novel diagnostic for glaucoma
Glaucoma is the major cause (15 per cent) of irreversible blindness worldwide. A recent UK report suggested 10 per cent earlier detection of glaucoma would save £1billion/year in treatment costs alone.
Professor Francesca Cordeiro and colleagues from the Institute of Ophthalmology at University College London, have been given Translation Award support to fund the preclinical development of their Detection of Apoptosing Retinal Cells (DARC) Technology. DARC is a novel technique that utilises the unique optical properties of the eye to allow direct visualisation of dying nerve cells. If successful, early diagnosis and treatment would mean that DARC will increase patient benefit and decrease burden of care costs.
Professor Francesca Cordeiro and colleagues from the Institute of Ophthalmology at University College London, have been given Translation Award support to fund the preclinical development of their Detection of Apoptosing Retinal Cells (DARC) Technology. DARC is a novel technique that utilises the unique optical properties of the eye to allow direct visualisation of dying nerve cells. If successful, early diagnosis and treatment would mean that DARC will increase patient benefit and decrease burden of care costs.
Translation Award
Simple rapid test kit for early diagnosis of EPEC
Translation Award support has been given to Professor Peter Williams and Dr Uta Praekelt to develop a rapid enteropatogenic Escherichia coli (EPEC) diagnostic kit for use in health centres in developing countries where resources and personnel are limited.
By testing all children with diarrhoea, those with EPEC can be identified quickly and subsequently receive appropriate treatment, reducing the likelihood of long lasting clinical complications.
By testing all children with diarrhoea, those with EPEC can be identified quickly and subsequently receive appropriate treatment, reducing the likelihood of long lasting clinical complications.