The AFCs neatly solve the problem of scalability and repeatability for EV isolation in research, product development and clinical use. The AFCs use a very precise method of measuring fraction volume. The size and number of fractions can be easily optimised and programmed by the user to maximise the purity and yield of isolated EVs. The user is then free to do more important work while the AFC performs its tasks.
The AFC - Beta
One of the key drivers for the AFCs has been the need for worldwide standardisation of EV isolation, measurement and analysis. Izon Science views it as a signal to noise problem, where the “noise” is the random variation caused by non-repeatable methods.
For instance, ultra-centrifugation has been commonly used in EV research but is not scalable or repeatable without introducing random variations in the sample collected. The use of the AFC + qEVs is expected to quickly make ultra-centrifugation obsolete in the EV world.
The AFC will use “smart” columns in a world first application of RFID technology. Izon has designed and developed an RFID reader/writer for the AFC. Each qEV column will have an RFID tag with addressable memory, which will store column parameters, production and QA data as well as usage data including the number of uses and cleaning cycles. The use of electronic data capture is particularly relevant for large scale biomarker analysis trials. Further development of this capability is expected to occur with detailed input from users and regulators.
The introduction of SEC columns, in particular the qEV range, was a significant advance for the EV field in 2014, offering the cleanest EV samples available at that time. They were first developed by the Academic Medical Centre in Amsterdam and subsequently developed for worldwide sale by Izon Science Ltd. The current introduction of higher precision and automation for the qEVs is an equally important advance, enabling the scale up potential that the field badly needs, with a significant improvement in quality at the same time.
A limited number of beta versions of the AFC are being offered to existing customers now, with a free upgrade and much wider availability of the full version 1 release due in early May.