The year of 2013 ended with a bang for the field of health technology. And in my haste to cover as many stories as I could before the year ended, there were some rather interesting news developments which I unfortunately overlooked. But with the New Year just beginning, there is still plenty of time to look back and acknowledge these developments, which will no doubt lead to more in 2014.
The first comes from the UK, where the ongoing fight against cancer has entered a new phase. For years, researchers have been developing various breathalyzer devices to help detect cancer in its early phases. And now, a team from the University of Huddersfield plans to introduce one such cancer-detecting breathalyser (known as the RTube) into pharmacies.
According to Dr Rachel Airley, the lead researcher of the Huddersfield team, these molecules – which consist of genes, proteins, fragments of cells, secretions and chemicals produced by the metabolism of living tissue with the disease – form a kind of chemical and biological signature. Using breath testing devices like the RTube, Dr Airley developed a project to define a lung cancer “biomarker signature” that is detectable in breath.
According to Dr Airley:
When you get certain chemicals in someone’s breath, that can be a sign that there is early malignancy. We are looking to be able to distinguish between patients with early lung cancer and patients who have maybe got bronchitis, emphysema or non-malignant smoking related disease… or who have maybe just got a cough.
The goal of the project is to validate the signature in a large number of patients to ensure it can reliably distinguish between lung cancer and non-cancerous lung disease. Dr. Airley told us that this will require tracking the progress of patients for up to five years to see if the disease develops and can be linked back to a signature picked up in the patient’s breath at the beginning of the project.
So far, the project has secured £105,000 (US$170,000) in funding from the SG Court Pharmacy Group with the University of Huddersfield providing matching funding. The SG also operates the chain of pharmacies in the South East of England where the initial trials of the breathalyzer technology will be carried out.
The researchers predict that people visiting their local pharmacy for medication or advice to help them quite smoking will be invited to take a quick test, with the goal of catching the disease before the patients start to experience symptoms. Once symptoms present themselves, the disease is usually at an advanced stage and it is often too late for effective treatment.
Dr Airley stresses that the trial is to test the feasibility of the pharmacy environment for such a test and to ensure the quality of the test samples obtained in this setting are good enough to pick up the signature:
There are 12,000 community pharmacies in Britain and there is a big move for them to get involved in primary diagnostics, because people visit their pharmacies not just when they are ill but when they are well. A pharmacy is a lot less scary than a doctor’s surgery.
Dr Airley also says her team is about to start collecting breath samples from healthy volunteers and patients with known disease as a reference point and hope to start the pharmacy trials within two years. If all goes well, she says it will be at least five years before the test is widely available.
The next comes from Germany, where researchers have created a test that may help doctors predict one of the most severe side effects of antidepressants: treatment-emergent suicidal ideation (TESI). The condition is estimated to affect between four and 14 percent of patients, who typically present symptoms of TESI in the first weeks of treatment or following dosage adjustments.
So far doctors haven’t been able to find the indicators that could predict which patients are more likely to develop TESI, and finding the right medication and testing for side-effects is often a matter of simple trial and error. But a new test based on research carried out by the Max Planck Institute of Psychiatry in Munich, Germany, could change all that.
The researchers carried out genome-wide association studies on 397 patients, aged 18 to 75, who were hospitalized for depression, but were not experiencing suicidal thoughts at the time they began treatment. During the study, a reported 8.1 percent of patients developed TESI, and 59 percent of those developed it within the first two weeks of treatment.
To arrive at a list of reliable predictors, the team genotyped the whole group and then compared patients who developed TESI with those who didn’t. Ultimately, they found a subset of 79 genetic variants associated with the risk group. They then conducted an independent analysis of a larger sample group of in-patients suffering from depression and found that 90 percent of the patients were shown to have these markers.
In short, this test has found that the most dangerous side-effect of antidepressant use is genetic in nature, and can therefore be predicted ahead of time. In addition, the research shed new light on the age of those affected by TESI. Prior to discovering that all age groups in the study were at risk, the assumption had been that under-25s were more at risk, leading to the FDA to begin issuing warnings by 2005.
According to some experts, this warning has had the effect of reducing the prescription of antidepressants when treating depression. In other words, patients who needed treatment were unable to get it, out of fear that it might make things worse. This situation could now be reversed that doctors can avail themselves of this new assessment tool based on the research.
The laboratory-developed test, featuring a DNA microarray (chip), is being launched immediately by US company Sundance Diagnostics, ahead of submission to the FDA for market clearance. As Sundance CEO Kim Bechthold said in a recent interview:
A DNA microarray is a small solid support, usually a membrane or glass slide, on which sequences of DNA are fixed in an orderly arrangement. It is used for rapid surveys of the presence of many genes simultaneously, as the sequences contained on a single microarray can number in the thousands.
Ultimately, according to Bechthold, the aim here is to assist physicians in significantly reducing the risk of suicide in antidepressant use, and also to provide patients and families with valuable personal information to use with their doctors in weighing the risks and benefits of the medications.
Wow! From detecting cancer to preventing suicides, the New Year is looking bright indeed! Stay tuned for good news from the field of future medicine!