EU-funded researchers have developed a compact portable lab that can deliver fast and accurate diagnosis of bacterial infection, in particular blood poisoning in infants. Huge markets in several application areas await the results of final clinical testing due next year.
Sepsis is a severe reaction to infection which, as it spreads through the bloodstream, develops into septicaemia. The germs causing this infection can be bacteria, viruses or fungi and can result in organ failure and, left unchecked, death.
Many patients, especially fragile newborns, can’t wait the two or three days that it can take to receive the results of a blood or serum test. Today, neonatal sepsis strikes hundreds of thousands of babies each year, with death rates ranging from 35-70 %.
The ASCMICROPLAT project developed portable lab-on-a-disc technology to speed up detection of both neonatal sepsis and sepsis-causing bacteria from serum samples. The mission: faster diagnosis leading to faster and more targeted treatment.
“Currently, a significant percentage of antimicrobial treatment is inappropriate, so a fast, accurate and integrated point-of-care diagnostic solution could help to significantly improve the prognosis for patients with suspected sepsis,” says Daniel Mark of the Institute for Micro- and Information Technology of the Hahn-Schickard Society at the Albert-Ludwigs University in Freiburg, ASCMICROPLAT’s coordinator.
The aim is to keep things simple, he says: “The doctor takes a sample from the patient and loads it into the device. Within about 180 minutes of pushing the button the doctor receives information about the pathogens present in the sample and decides on the appropriate treatment.”
The sepsis diagnosis works as a ‘sample in, result out’ process using a fine-tuned centrifugal micro-fluidic platform to separate the pathogen’s DNA from the serum/blood, and an innovative foil-technology (a so-called LabDisk) to form the disposable sample carriers. This technology can be scaled up for industrial production and the project coordinator is currently setting up a pilot line for manufacturing the LabDisks.
The first prototype has been successfully tested at the Competence Centre for Modern Food Analytics in Berlin. Clinical trials in Ireland have now validated the system, though further testing and funding are needed before wider commercial rollout of the technology can be considered, says the team.
Applications + markets = success
The global molecular diagnostics market that ASCMICROPLAT’s technology would aim to compete in is estimated to be growing at around 10 % annually (CAGR) and could reach nearly $8 billion (€7.2 billion) by 2018, according to a report from MarketWatch, a research firm.
The driving forces behind this growth, notes the report, include rising incidences of infectious diseases, genetic disorders, cancer, and technological developments like portable equipment.
In fact, medical diagnostics is just one of the possible market applications for the LabDisk, says the ASCMICROPLAT team. Such a simple and fast-working diagnostic system can also be used to detect infectious disease at airports and other major transport hubs. The ability to accurately identify and isolate infected travellers could help prevent wider pandemics.
“Point-of-care testing for infectious diseases is a very promising and rapidly growing market. Recent deals … in the range of $450 million for rapid diagnostics show how hot the topic is,” says Mark.
The ability to scan food for bacterial infection is another application being considered by the consortium, which includes research and biotech partners from Germany, Ireland, Switzerland and Finland.
But the healthcare sector and hospitals are likely to be the principal beneficiary of the ASCMICROPLAT portable lab, helping them save time, money and ultimately lives thanks to faster and more accurate diagnosis.
In 2016, the launch of first products for non-diagnostic applications is planned. Due to the strict regulations in medical diagnostics, products in this field could require another three years or so.