Solis BioDyne and Steinbeis collaborate to commercialize diagnostic reagents
One thing quickly became clear in the current COVID-19 pandemic: the only way to understand and efficiently break the chain of infection would be to start widespread, reliable testing programs. This fueled a strong demand for safe and easy-to-use testing reagents developed and produced according to regulatory approval standards. Solis BioDyne, an Estonia-based leading supplier of life science reagents, rose to the challenge and quickly developed an easy-to-use 1-step RT-qPCR test and a corresponding protocol for the detection of SARS-CoV-2. Since last year, the company has been supported by experts at the Steinbeis Transfer Center for Medical Engineering & Life Sciences in country-specific market entry and marketing activities.
EXPERTISE IN REAGENTS FOR DIAGNOSTIC TESTS
The test for the COVID-19 inducing virus is based on the detection of viral RNA which is extracted from nasal or throat swabs of persons to be tested. After extraction, the viral genome is first transcribed into the more stable DNA molecule in a test tube by an enzyme (reverse transcriptase) using the so-called reverse transcription (RT) method. In the subsequent quantitative polymerase chain reaction (qPCR – quantitative polymerase chain reaction), the specific DNA is then multiplied by another enzyme (DNA polymerase) and subsequently detected. If the swab picks up viral genome sequences, they are amplified and detected in the qPCR resulting in a positive test result.
The test is based on specific components that work together in a coordinated manner. At the center is a set of unique proteins – the reverse transcriptase & DNA polymerase. Optimized buffer solutions are also of great importance for a successful test. Testing can be simplified and carried out in a single step by allowing the reverse transcription and the qPCR to take place after one another in the same test tube. Not only does this save time, it also reduces the likelihood of errors and increases test capacities. During the pandemic, such 1-step tests, measurement protocols and pre-formatted reagents quickly became the limiting factor in the rapid execution of reliable diagnostics. This is where the expertise of Solis BioDyne came in. The company has already been developing and marketing components for PCR-based applications for 25 years and gained approvals for producing reagents for use in diagnostic testing in 2007 (ISO standard 9001) and 2018 (ISO standard 13485).
Building on years of experience and a clear understanding of the relevant regulatory standards, Solis BioDyne quickly delivered diagnostic reagents to international markets at an early stage of the pandemic. “We already had a strong international customer base both in research and diagnostics. We are pleased that we can make a positive contribution in this crisis by supporting test laboratories” reports CEO Kadri Artma.
COUNTRY-SPECIFIC MARKET ANALYSIS WITH STEINBEIS
Since its foundation, Solis BioDyne has remained true to its core competence in the areas of PCR, qPCR and cDNA synthesis applications, focusing on quality and flexible service. Its patented technology makes it possible to develop unique temperature-stable enzymes that retain their specific activity at room temperature for several weeks. Today, the company is well positioned in research and diagnostics. This is partly the result of collaboration with the Steinbeis Transfer Center for Medical Engineering & Life Sciences. In the summer of 2019, the company decided to build on previous organic growth and work with the experts at Steinbeis on expanding operations in different geographies. A partnership with the Estonian economic development foundation Enterprise Estonia (EAS), which also works with Steinbeis, was extended by tapping into specific expertise in marketing in the life science industry.
Solis BioDyne is in the process of expanding its commercial activities in various European countries and was looking for country-specific information for the life science market. Here, Prof. Dr. Tobias Preckel, expert at the Steinbeis Transfer Center for Medical Technology & Life Sciences supported the project. To kick off the project, he worked with Solis BioDyne to analyze the company’s comprehensive product portfolio, with a particular focus on customer requirements in the different market segments. Particularly, the Steinbeis experts looked carefully at the perceived value of certain product attributes in specific applications. In addition, a competitor analysis was created and marketing strategies for each country were developed.
Furthermore, the impact of various traditional and digital marketing efforts on customer reach was compared and yielded significant differences depending on market segment. It soon became clear that the exceptional stability of the DNA polymerases, reverse transcriptase, and other critical proteins developed and manufactured by Solis BioDyne is a key feature that lends these products to diagnostic applications. It allows shipping these products at ambient temperature, unlike competitor reagents. This not only saves extensive shipment cost but also provides a safety margin of stability when the reagents are used in laboratories in diverse climates all over the world. “It becomes clear that Solis BioDyne’s enzymes are ideal for the use in non-cooled automated workstations because of their stability at ambient temperature. Both features, room-temperature shipments and use in non-cooled automated systems, provide clear benefits in diagnostic settings.” says Simon Robberts, business development manager at Solis BioDyne.
Follow-on project already in the starting blocks
Moving forward the company is well positioned to strengthen its foundation in research market segments and engage with a growing customer base of diagnostic reagent users. DNA-based testing is becoming more and more important, not just for research but also for diagnostic purposes. The medical indications to which it can be applied range from identifying pathogens to bacterial antibiotic resistance and tumor-typing. Following the successful partnership, the next collaboration agreements are now being lined up: “It’s a major challenge finding qualified specialists to fill the vacancies,” reports Robberts. “We are working with Steinbeis on this aspect as well.”
Prof. Dr. Tobias Preckel (author)
Steinbeis Transfer Center Medical Engineering & Life Sciences (Marxzell)