Prolight Diagnostics started the development of PLD Micro Flex, based on Prolight’s Micro ELISA, in combination with The Technology Partnership's (TTP's) (link to Partnership) Flex membrane technology in January 2017. TTP has extensive experience of development work according to international standards, which is crucial to high quality. The company is an independent and leading technology development company based in Cambridge, UK, with approximately 236 technically highly-qualified employees. The collaboration thereby ensures the development of PLD Micro Flex in an international top class.
The development of our Point-Of-Care Testing (POCT) platform is divided into three different stages. Planning is underway for the third and final product development stage.
The company is developing a strategy for the third development stage for how further development of instruments and test cards at TTP will take place in order to meet market requests and requirements in the best way. The third development stage may include more biomarkers, in order to be able to test more markers at the same time, so-called multiplex. The focus will be on verifying and validating the results the POC system generates relative to current industry standards and criteria set by the market and regulatory framework.
The second product development stage of instruments and test cards was carried out with positive results. Prototype instruments and more than 200 test cards were evaluated by TTP (The Technology Partnership plc). All individual functional processes, "core functionality", which are necessary to be able to test highly sensitive Troponin on the company's Point-Of-Care platform worked well, for both instruments and test cards. The progress led to four new patent applications.
The first product development stage was completed in March 2018, and during the development there was a focus on functionality and test performance to measure a biomarker. The measurement of highly sensitive Troponin was prioritised in relation to parallel measurement of several markers in a first stage. During the first product development phase, the instrument showed the desired chemical and technical performance. The most important measurement parameter, sensitivity (i.e. the ability to measure very low levels of Troponin), developed well in line with the project's expectations, and exceeded the criteria set by the cardiac diagnostics market.