about us


About us!


Our strength and motivation:

AmplexDiagnostics GmbH is a German privately owned and independent company for applied sciences, specializing in microbiological issues with fast and professional molecular solutions in the field of CE IVD diagnostics. The close cooperation with international scientists leads to a fruitful European network that inspires our research and development department and optimizes our portfolio. These brand new findings are an integral part of our CE IVD products and are passed on directly to all of our customers. The company was founded in 2002, with Munich as the development and production site. In 2010 the sales and marketing department first moved to Gießen and in 2019 to Buseck. The development and production departments have been located in Gars-Bahnhof since 2005 and are characterized by constant growth. Growing means finding new niches in order to optimize routine processes and work in a highly customer-oriented manner. Mainstream is not the way we think.

eazyplex®- System

Our products:

With the eazyplex® system, Amplex makes the latest advanced  technology available in a simple and user-friendly manner. The device, which can be operated intuitively, combines isothermal amplification (LAMP) with real-time detection. Part of our concept are the lyophilized and ready-to-use reagents, which guarantee user-friendliness, speed and reliability. These advantages of our system are appreciated by all of our customers, from small hospitals, large university institutes, laboratory doctors to outpatient health centers (MVZs). Our hyplex StaphyloResist® was the world's first MRSA multiplex PCR test evaluated with the CE IVD standard for testing directly from sample material. The first ESBL test was established on the same platform. And so it is only a logical consequence that Amplex is right now again one of the first providers of LAMP-based CE IVD-marked diagnostics.

our eazyplex tests

Our team:

Our team is made up of people with skills and experience. Our strength is to integrate our customers and to appreciate them as team members in order to develop needs-based solutions together. As a team of experts, we focus on short decision-making paths, clear communication and competent solutions for diagnostics.

Our mission:

We are a competent partner to all of our customers around the world and offer them excellent CE IVD diagnostics for various types of pathogens that cause health problems.

Our vision:

Excellent diagnostics from AmplexDiagnostics GmbH to prevent infections, help patients and save lives around the world.

Quality management:

AmplexDiagnostics GmbH is certified according to DIN EN ISO 13485. For Amplex it is a matter of course to guarantee the highest standards in the development, manufacture and sale of CE-IVD diagnostics. Of course, our QM system is certified according to IVDR!

„The eazyplex® Amplex system (provided by Arrow Diagnostics SRL) was established in our UOC Clinical Pathology lab activity in 2017. The aim was to find a system of simple execution and interpretation which could be used 24 hours in the diagnostic path for suspicion of "Invasive bacterial disease" and/or of bacterial meningitis.

The system immediately proved to be easy to execute, robust and immediately interpretable and contributed to providing an indispensable diagnostic service in short times.

Thanks to the reporting times, it allowed us to keep under control extremely infectious pathology and above all to avoid “PROPHYLAXES” when not necessary.

Over time, the UOC has implemented the use of the system, equipping itself with tests for the control of healthcare-related infections and for the detection of resistant bacteria from positive blood cultures

This last test has helped us to develop an algorithm that allows us to give a PRELIMINARY indication of genus, in certain cases of genus and species and of the most frequent and fearful resistance genes, of the bacteria responsible for bacteremia and/or sepsis. This allowed us to reduce the preliminary response times compared to those of classical microbiology (1 hour with algorithm using eazyplex®, compared to 24/48 hours of classical microbiology).

The versatility of the system allowed us to build also additional "home-made" algorithms capable of helping wards to control infections at various levels (surgical site, prosthesis, other ...)

We also recently evaluated the new test eazyplex® SARS-CoV-2 for the detection of SARS-CoV-2 virus. We believe such a test to be very useful and certainly reliable due to the presence of "sample, inhibition and lysis controls" as this provides the clinical pathologist with the certainty of sample congruity. The choice of adopting the amplification of the ORF8 gene is also appreciable, an unusual choice for rapid molecular tests but which, once again, allows the clinical pathologist to be CERTAIN about virus detection.“

Dr. Vittoria Fabbrizi

UOC Clinical Pathology

Teramo Hospital

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