09 November 2020

Polpharma supported the development of first Polish genetic test detecting SARS-CoV-2

PAN scientists and Polish companies successfully developed a proprietary diagnostic test to make Poland independent from external SARS-CoV-2 test supplies. MediPAN-2G+ FAST COVID, the first Polish genetic test, is already available on the market in its final form. It is the fastest of all diagnostic tests currently in use, highly sensitive and developed entirely in Poland.

The initial period of the COVID-19 pandemic demonstrated the importance of becoming independent from foreign supplies of medical resources to the Polish population. Thanks to the great mobilization of scientists, working hand in hand with businesses and benefitting from government assistance, the final version of the first Polish genetic test has just hit the market and is likely to ensure the country’s supply independence. The test has been developed by a team of scientist volunteers of the Institute of Bioorganic Chemistry of the Polish Academy of Sciences (PAN) in Poznań. In development since March, the MediPAN-2G+ FAST COVID kit is currently the fastest and one of the most sensitive SARS-CoV-2 detection tests on the market. If introduced to labs, it would optimize their efficiency and thus reduce the time patients need to wait for the results. The kit received a positive review from the National Institute of Public Health – National Institute of Hygiene. The development of the first Polish test is a model example of collaboration between a research facility and Polish business. The companies involved in the development, manufacturing and marketing of the test were Polpharma, Medicofarma, Future Synthesis and A&A Biotechnology.

Project milestones

In response to the shortage of coronavirus detection tests, in the spring of 2020 a group of scientist volunteers from the Institute of Bioorganic Chemistry of the Polish Academy of Sciences in Poznań launched a concerted effort to develop their own proprietary genetic test. Its development was not only a scientific accomplishment but also a unique organizational feat at the time of the lockdown affecting many areas of the economy. Thanks to the cooperation with Polish companies, in a matter of months the project was scaled up from inception, through process evaluation and optimization, to mass production. The involvement of Polish companies and the use of locally available reagents made it possible to reduce the test unit price and secure the needs of the Polish population in the face of a possible next wave of the pandemic. The project received a grant of PLN 15 million from the Polish Ministry of Science and Higher Education and PLN 100,000 from the local government of the Wielkopolska Region.

“The launch of the test on the market is not only a scientific success but also the result of a seamless cooperation. It is also a spectacular example of how cooperation between scientists and business, as well as local and central government authorities, may create a synergy effect which would otherwise be unachievable. At that time, so difficult for everyone, it was natural for our Institute to initiate work on the test. We knew we had the knowledge, competences and technical facilities necessary to develop a product which would match or exceed the quality of other tests available on the market. However, already during preliminary work we realized that we needed a partner to help us market the product. Today, we can safely say that without the manufacturing facilities and business acumen of Polish businesses, including Medicofarma, Polpharma, Future Synthesis and A&A Biotechnology, the test verification stage would have taken much longer. As a result, the test could have never become available to diagnosticians,” summarizes Professor Marek Figlerowicz, Director of the Institute of Bioorganic Chemistry of the Polish Academy of Sciences.

The fastest test on the Polish market

The final version of the MediPAN-2G+ FAST COVID genetic test is used to detect two specific SARS-CoV-2 genes. Its efficacy has been confirmed by independent laboratories using various diagnostic tools.

What makes the test unique?

    • Speed – it is the fastest test currently available on the Polish market. The short RT-PCR reaction time (ca. 1 hour) may significantly improve the efficiency of laboratories’ work (it reduces detection time by half), thus making the results available to patients sooner.
    • High sensitivity of the reactions detecting the virus (>99%).
    • Specificity – the test detects both SARS-CoV-2-specific genes, which is an advantage over tests where one of the detected genes is a screening gene characteristic of the entire coronavirus family.

Making the Polish system independent

The development of the first Polish test is a model example of cooperation between a research entity, business and the government. The cooperation resulted in the development of a commercialized biotechnical product ready to be used in the healthcare setting.

We are therefore facing a chance to make Poland independent from the imports of foreign tests and components for their production and thus to ensure universal availability of COVID-19 diagnostic tests, which is especially important in the context of the rising worldwide numbers of infection cases and potential new closing of borders.

It is a huge success of young researchers who initially worked on the test as volunteers and also validates the need to build close relationships between science and business for the development of Polish innovation.

The prototype test was designed and produced at the Institute of Bioorganic Chemistry of the Polish Academy of Sciences in Poznan. The company in charge of taking the product from laboratory scale to production scale was Medicofarma, who also ensured comprehensive manufacturing. Meanwhile Polpharma supported the work required to transform the prototype into a commercially optimized product with the desired properties, which could be scaled up from the laboratory to mass production.

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