Prolight Diagnostics was founded in 1999 in Lund by Masoud Khayyami, PhD in Chemistry at Lund University. The goal was to develop a diagnostic test that could quickly determine if a patient had a heart attack, with a Point-Of-Care test. By measuring substances released from the heart into the blood during the acute myocardial infarction phase, rapid diagnosis can be established. Since then, the development of POCT has progressed. Prolight Diagnostics has focused on developing a system for the biomarker Troponin, a marker that measures whether a patient has suffered a heart attack. We have received indications from the market to develop our POC platform to include more biomarkers. Our flexible testing system can, therefore, be modified to be able to measure markers in, for example, cancer, inflammation, stroke, etc. in the future.
A patent application is submitted, which is based on an innovative solution to be able to use the sampling tube for blood collection from, for example, the crook of the arm, directly in the automated process. This avoids manually transferring blood in a speciifed amount via pipetting, for example, from the sampling tube to the test card before it is inserted into the instrument for analysis. This results in fewer handling stages and a simpler, quicker, and more robust handling.
Ulf Bladin takes over as the new CEO.
A private placement is carried out, adding approximately MSEK 55, before transaction costs, to the company.
Development stage 2 of Prolight Diagnostics' development of instruments and test cards has been completed with positive results. Two prototype instruments and more than 200 test cards have been 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 have worked well, for both instruments and test cards.
Two new patent applications related to method and application have been filed by technology partner TTP on behalf of Prolight to "The Intellectual Property Office" in the UK.
A further application is submitted, which is based on a highly innovative solution for separating plasma from whole blood. The separation is carried out with very high precision and in Point-Of-Care format – as such, the separation requires very little physical space and is done in a short time.
A private placement is carried out which adds approximately MSEK 21.2 to the company, before transaction costs.
The PLD Micro Flex platform, where the Micro ELISA technology from Prolight Diagnostics is combined with TTP's microflow technology, shows the expected performance, robustness and reliability. The goals for development stage 1 have been achieved. The Board of Directors issues positive confirmation to start development stage 2.
The instrument design begins to take shape, with focus on safety and ease of use for the user. Most of the components included in the instrument are now selected.
The company is listed on NGM Nordic MTF.
Prolight starts the development of a new test platform, "PLD Micro Flex" based on Prolight's Micro ELISA in combination with TTP's Flex membrane. The ambition is to create a platform with high test performance and flexibility.
Intensification of work and new opportunities - Development stage 1
In light of an increased interest and acceptance of POCT tests in most clinical areas, the company decided to intensify the work, and investigate opportunities for further development of the concept.
It turned out that TTP had meanwhile developed a technology for other applications, flex membrane, which means that it is possible to create reaction chambers between fused plastic layers where substances can be measured with high accuracy, due to fact the flow of reagents can be controlled with high precision. It is also possible to measure several substances in parallel, plus the instrument construction is simpler. The technology is patented.
Patents are registered in several European countries.
Patents are registered in the United States.
The technology, which is based on ELISA technology in miniature format, was patented in Sweden. Manufacturing costs and market acceptance were judged to be disadvantageous and further investments and development work were minimised.
A collaboration with The Technology Partnership, (TTP), based in Cambridge UK is established. The first prototype "lab-on-a card" was developed. A disposable chip the size of a credit card, where all chemical reactions were performed. To drive the reactions in the various reaction chambers and channels of the card, the liquids were mechanically pumped. It was shown that the method worked. The platform was suitable as intended for Point-Of-Care Testing (POCT).
Prolight Diagnostic is founded.