Molzym announces FDA Breakthrough Device Designation for its Molecular Diagnostic Test System – Sepsis, Joint & Implant infections, Infective Endocarditis, Bacterial Meningitis

Breakthrough Device

10 May 2021

Molzym’ s unique technology for molecular microbial diagnostics was granted Breakthrough Device Designation (BDD) by the FDA in light of its capacity to aid the diagnosis of selected conditions as an adjunct to the current standard of care.

The FDA BDD Program aims at providing patients and health care providers with timely access to these breakthrough medical devices and enhances Molzym’s marketing strategy. Read more in our press release.



Molzym GmbH & Co. KG and Fraunhofer IZI-BB Joint Research and Development Project

02 December 2020

AutoSepTIn our latest press release we are delighted to present our new funding project: in collaboration with Fraunhofer IZI-BB, we develop an automated sepsis diagnostic for fast testing in clinical laboratories.

The new analytical platform, called AutoSepT, which will identify the most frequent sepsis-causing pathogens.

Read more about the project including a statement of the project leader, Dr. Michael Lustig, in our press release.





Webinar Recording „Management of Bacterial and Fungal Infections: Efficiency of Culture-Independent Molecular Testing”

25 November 2020

Dr. Michael Lustig, Molzym’s COO, shares in this webinar his vast experience in direct molecular testing beginning blog webinarwith the limitations of conventional cultures and the culture-independent approaches available.

Get an overview of available solutions, their advantages and disadvantages. Get to know the aspects that favour direct molecular testing and learn about the diagnostic value and clinical impact of broad-range 16S & 18S rRNA analyses.

Please find the product information for our diagnostic solutions here and do not hesitate to contact us if you have any questions.

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Webinar Recording “Direct Molecular Testing of Infectious Pathogens”

14 September 2020

blog webinar

How can molecular diagnostics be used for the identification of pathogens and resistance genes? What to consider with the different molecular diagnostic methods at hand and how to evaluate the results?

Request the recording of the live-webinar about “Direct molecular testing of infectious pathogens” by Prof. Dr. med. Sören Schubert from the Ludwig-Maximilian-University (LMU) Munich and learn about molecular diagnostics and his tips for clinical practice.

One of the methods presented is our Micro-Dx™ kit and we are very happy to answer any questions on the kit or technology.

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Molzym Announces New Board of Directors to Accelerate Growth of its Molecular Diagnostic Solutions

Molzym Bremen

09 July 2020

Molzym’s team is ready to expand its unique microbial molecular diagnostic solutions for tomorrows’ Healthcare systems, and glad to announce a new Board of Directors has joined to accelerate its growth. We are happy to share with you the latest press release with statements from our new Chairman, Jakob Glatz, and the CEO of Gradian and Molzym, Gabriel Tirouflet.

Open press release 



Early Identification of Microbial Co-Infections in Critically-Ill COVID-19 Patients

28 April 2020

Collecting dataTime is crucial for critically-ill COVID-19 infected patients.

We are glad to share that several European and Asian centres have started a collaborative study to use Micro-Dx™ and SepsiTest™-UMD to early identify co-infections in COVID-19 infected patients. The efficiency of our rapid molecular diagnostic solutions shall reveal life-threatening outcomes, especially in emergency situations.

With our culture-independent IVD-marked tests bacterial and fungal co-infections can be detected in respiratory aspirates (BAL and Sputum), blood, tissues and other primary sterile specimens within 7 hours compared to conventional culture methods which usually take several days.

An early and precise detection of co-infections in COVID-19 patients could help to administrate efficient targeted therapy.

Centres that have interest to collaborate or want to learn more about our solutions are welcome to contact us anytime.



Molzym Operational Status - Statement to COVID-19

23 March 2020

Covid 19 141427609 340x255 blauAs COVID-19 continues to impact the globe we want to address how Molzym is dealing with the current situation.

Operational Status
We are fully operational and have not experienced any impact on resources and logistics yet and process orders as usual. For the safety of our customers and employees, Molzym is taking any precautions to prevent the spread of COVID-19. Therefore, we have implemented strict travel restrictions and whenever possible our staff is working from home office.

Manufacturing & Shipping
We have implemented a shift-based system for production, assembly, processing and shipment of orders. Two teams plus backup staff are working without having direct contact to each other to ensure the supply of your products as you are used to. We are permanently monitoring our supply chain and are in close contact to our suppliers and freight forwarders to understand and identify any risks in supplies and shipments as early as possible. If there are any delays in production or delivery we will notify you immediately.

Customer Service & Technical Support
Our Customer service and technical support is available during regular business hours to help you with your needs and to answer your questions on the phone or via e-mail.

We will continue to monitor the COVID-19 situation and will update our operational status if needed. 

Please follow the link for the pdf version of this statement.



Molzym is Now Part of Gradian Diagnostics!

16 December 2019


We are very pleased to inform you that Molzym GmbH & Co. KG has joined Gradian Diagnostics. Being part of Gradian Diagnostics allows us to accelerate growth and develop new innovative solutions that help hospitals and labs with the challenges and opportunities they face today and in the future in routine microbial pathogen diagnostics and molecular microbiology research.

Our highly experienced team of researchers, technicians and diagnostic specialists in addition to our businesses and services will remain unchanged. Our customers, distributors and partners can continue to rely on our high quality solutions and our excellent support. The offices and production site will remain in Bremen, Germany.

Gradian Diagnostics is a holding company based in Miami, USA, working on expanding diagnostic solutions by acquiring assets and companies with validated products around the world. Please follow the link for the official press release.