Molecular Diagnostics – Chances to Discover New Innovations

Interest in the molecular diagnostic field has been gaining momentum lately and while molecular diagnostic takes a relatively small portion of the entire diagnostic market, various market analysts have identified this segment to have the fastest growth in the next few years.

This growth is based on several factors, especially on rapid improvements in methodologies and technologies within the segment, resulting in fast result turnaround with low cost due to convenient workflow and high sensitivity. For this issue we have interviewed the people of Genetek Biopharma® GmbH, a company specializing in developing and producing molecular kits situated in the outskirt of Berlin, to understand their work and needs. This municipal is set to develop Germany's most modern science and technology park - Adlershof. It’s tagline “Science at Work” sets the direction for the Berlin Adlershof Science City in realizing its vision to be one of Berlin's future destinations as well as one of the most successful high-technology locations in Germany.
Genetek Biopharma was initiated by Professor Sirous Zeinali, and the company was registered in March 2017 with the help of Mr. Alambeigi. Armed with intensive R&D and experience in producing and using molecular kits, the founders decided to establish the company in the prospering science and technology park in Berlin. To date, Genetek Biopharma’s product portfolio covers the areas of human genetic diseases, human identification, and animal identification. When asked why was the company set up and what was being envisioned when the founders started the company, the spokesperson replied, “We thought that the market is in dire need of user friendly, higher quality and more affordable molecular diagnostic kits. The diagnostics market is growing rapidly and new advances in genetics require more diverse diagnostic kits and tools. So, part of Genetek Biopharma’s future activities will focus in producing molecular diagnostic kits and reagents. In the future, its activities will diverse to other areas related to human health.”

Figure 2: Genetek Biopharma’s post-PCR research laboratory: Very cleaned up laboratory set-up to reduce the risk of contamination

According to Genetek Biopharma, with the completion of Human Genome Project in 2003 and the advent of NGS technology, personalized medicine is becoming even more real. Existing medical molecular diagnostic practices also require new discoveries and technologies. The market is huge and competitions are stiff. A new product may become outdated very soon. Hence, in this highly challenging market, one company can’t relax in having one or few products in the market.

Apart from external pressure, molecular diagnostic kit production is not as simple as mixing a few components together and running some DNA-based experiments. Various considerations need to be taken in order to ensure end-product quality. For example, separation of pre- and post-PCR lab structure is extremely important to minimize contamination risks. 

The most challenging part is the complex research step ahead of production. Therefore, a major advantage of Genetek Biopharma is the competence in research work. The time-consuming part in developing a molecular kit is to identify the optimal pooling ratio of different PCR products. This allows them to ensure the high quality of their multiplex PCR system in amplifying several genetic markers in a single reaction. 

And indeed, a visit to their laboratories and production facilities showed that a lot of thought has been put into the design to safeguard the developing process of their molecular kits. Devices were well organized and we could see how they placed the Eppendorf centrifuges, Mastercycler® nexus, and Mastercycler® X50 accordingly in their workflow for smooth working. 

In the face of this challenging yet rapidly expanding field, Genetek Biopharma hopes to continuously expand and improve their kits’ portfolios. From our conversation, the members of the company were filled to the brim with enthusiasm and ideas. The spokesperson indicated that the successful commercialization of new kits is based on reliable and dedicated R&D processes. 

It sounds like it won’t be long before we will see new innovations in the market, which will certainly benefit this market as well as its users as a whole.

Disclaimer: Genetek Biopharma® is a registered trademark of Genetek Biopharma GmbH, Germany. Eppendorf®, the Eppendorf Brand Design and Mastercycler® are registered trademarks of Eppendorf AG, Germany. All rights reserved including graphics and images. Copyright © 2019 Eppendorf AG.