Prolight Diagnostics has demonstrated Proof-of-Performance in whole blood for its digital test system Psyros. It is already known that the system performs as promised for measuring troponin in serum, as well as thyroid-stimulating hormone in blood plasma. The latest results show that the system has equivalent performance in whole blood. BioStock reached out to the company’s CEO Ulf Bladin to find out more.
Prolight Diagnostics is developing a digital analysis system, Psyros, that can detect single molecules of biomarkers in the blood. The company uses the technology to measure troponin, a protein released into the blood during myocardial infarction.
Traditionally, blood samples have been sent to a hospital laboratory for analysis in the event of a suspected heart attack. This is not necessary with Prolight Diagnostics’ point-of-care test system, which provides quick and reliable answers to whether the patient has a heart attack or not, even at very low levels of troponin.
Measuring in whole blood reduces complexity
Earlier this year, the company demonstrated proof-of-performance on its system for measuring troponin in human serum samples, which BioStock reported on in Börsronden. Serum makes up the upper part of a blood sample that remains after the blood has clotted and been centrifuged, and thus contains no blood cells or clotting proteins. Plasma has a similar composition, but with clotting factors.
Recently, Prolight Diagnostics announced that they have also obtained proof-of-performance in whole blood, i.e. blood that has not been separated by centrifugation. No need of cell separation eliminates another time-consuming step in the measurement of troponin, to detect or rule out myocardial infarction. This reduces the complexity and pave the way for more competitive pricing.
Verified with another system
The results show that the system gives equivalent performance in whole blood compared to plasma and that it can quantitatively measure the number of molecules in the single digit nanogram per litre range in whole blood. According to the company, there are no other single molecule counting platform that function with whole blood.
The system analysed troponin levels in fresh human blood samples, where plasma was added from patients with elevated troponin levels post myocardial infarction. The measured levels were verified using a commercially available high-sensitivity troponin assay.
ISO 13485 accreditation
Recently, Prolight Diagnostics made another positive announcement. The company’s subsidiary Psyros Diagnostics has been certified according to the international standard ISO 13485, which defines the requirements for quality management systems (QMS) for medical devices. The certification means that the company’s quality processes meet the global requirements, which is a prerequisite for market approval in Europe and the US.
Comments from the CEO
BioStock reached out to CEO Ulf Bladin to find out more about the importance of having received proof-of-performance in whole blood and ISO certification, as well as the benefits of the company’s test system.
First of all, what are the main advantages of being able to measure troponin in whole blood instead of in blood plasma/serum?
– The ability to measure in whole blood, without a cell separation step, reduces complexity and paves the way for an extremely competitive price level. In addition, the sampling volume can be reduced, which is an advantage when the blood sample is taken from the finger.
Could you tell us a little more in detail about how you conducted the tests to show proof-of-performance in whole blood?
– Fresh human blood samples were added to plasma from myocardial infarction patients with elevated troponin levels. The troponin concentrations in the blood samples were confirmed by measuring them in parallel on a commercially available system for highly sensitive troponin assays.
Finally, you have also recently received an ISO certification for your quality management system. Why is this important?
– The accreditation shows that our quality processes meet global quality requirements, which is a prerequisite for market approval in the US and Europe. We see the certification as proof of the high standard in our medtech development of a safe, high-quality point-of-care platform providing very accurate and fast diagnostic results.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.