An example of the new approach is seen in the way that several companies have been working to accurately and speedily diagnose zika virus.
In March, the US Food and Drug Administration gave authorisation to Roche for its Cobas Zika test which detects the infection using a newly-developed assay test in the company’s commercially available cobas 6800/8800 machinery. It is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual human blood donors.
Roland Digglemann, Chief Operating Officer of Roche Diagnostics, said: “These fully-automated high-volume systems provide solutions for blood services to detect the virus and ensure that potentially infected blood units are not made available for transfusion. “
The same platforms will process tests for a range of healthcare-acquired infections including Clostridium difficile and Methicillin-resistant Staphylococcus aureus. More efficient diagnosis of these conditions enables infection control protocols to be implemented quickly as well as allowing for better-targeted treatment. Other infectious diseases where similar tests have been developed include both viruses and bacteria. They range from cytomegalovirus and Human papillomavirus to Mycobacterium tuberculosis. Sexually transmitted infections such as herpes and gonorrhoea can also be diagnosed using this technique.
Markets are opening up for machinery which can process tests almost instantaneously, in close proximity to the patient and are as reliable as a major laboratory. Patients visiting a clinic or a hospital could, if the right machinery was installed, be tested, receive an accurate diagnosis and be prescribed the best treatment within a few hours.
In February, Bristol-based company Atlas Genetics announced EU approval for a Chlamydia trachomatis test on its ultra-rapid io platform and has plans to introduce similar tests for other sexually transmitted infections including Gonorrhoea and Trichomonas vaginalis.
The sample is placed in a disposable cartridge and an answer is produced in only 30 minutes, according to the company, all without compromising reliability. CEO John Clarkson said: “STIs are on the rise and the rise and the faster a diagnosis can be made, the faster treatment can be given, not only benefiting the patient but also saving time and money.” The medical imperative has led to systems which can process large volumes of tests in only two or three hours. Even when sample have to be sent to outside laboratories, results can come back in much shorter timescales than with previous testing systems.
The capacity of molecular diagnosis to achieve better outcomes for patients has been acknowledged by the World Health Organisation, particularly in relation to multidrug-resistant tuberculosis (MDR-TB). In May, the WHO announced that it was recommending the use of molecular diagnostic tests to identify patients who would benefit from a shorter, cheaper treatment regimen. The WHO said it would lead to better outcomes because patients would be more likely to see the treatment through to the end. Conversely, those patients resistant to some drugs would not be needlessly prescribed therapy to which they would not respond and which would only increase the likelihood of further drug-resistant strains of TB developing.
Dr Karin Weyer, co-ordinator of laboratories, diagnostics and drug resistance for the WHO global TB programme, said: “We hope that the faster diagnosis and shorter treatment will accelerate the much-needed global MDR-TB response. “Anticipated cost savings from the roll out of this regimen could be re-invested in MDR-TB services to enable more patients to be tested and retained on treatment.” In 2015, Arthritis Research UK announced that a consortium of scientists from around the world would be investigating the reasons some patients struggle to find a treatment for rheumatoid arthritis which works for them.
One stream of research is looking for biomarkers which predict which drug will be effective, reducing the time between diagnosis and treatment. The charity says that more accurate prescription could save the NHS £13 to £18 million a year on its drugs bill. Professor Costantino Pitzalis, of Queen Mary University, London, joint leader of the MARURA Consortium, said: “We can’t continue to use biological therapy on a trial and error basis. We need to find biological markers to identify patients who are likely to respond to the drugs they’re given.
“As well as improving diagnostics and finding better outcome measures, we can accelerate the discovery of new targets and develop new drugs.” Advances are also being made in the diagnosis and treatment of various cancers including oesophageal cancer, which has recently been found to come in three distinct types, as identified by the International Cancer Genome Consortium. Each type has identifiable DNA differences.
Professor Rebecca Fitzgerald, lead researcher on the project and based at the MRC Cancer Unit, University of Cambridge, said: “Our study suggests we could make changes to the way we treat oesophageal cancer. “Targeted treatments for the disease have so far not been successful and this is mostly down to the lack of ways to determine which patients might benefit from different treatments. These new findings give us a greater understanding of the DNA signatures that underpin different sub-types of the disease and means we could better tailor treatment. “The next step is to test the best approach in a clinical trial. The trial would use a DNA test to categorise patients into one of three groups to determine the best treatment for each group and move away from a one-size-fits-all approach.”
New disease-specific assays are being released all the time in this exciting and fast-paced branch of diagnostics. Competition is brisk as companies seek to tie assays into their analytical platform or produce a general assay for use across many different devices. In 2015, for example, Wirral-based Biofortuna appointed a new chairman, Ian Johnson, to oversee future growth in the company, which specialises in freeze-dried molecular diagnostic assays and offers a contract development service for in vitro diagnostics. It is not alone in taking an optimistic view of opportunities in the sector.
