Molecular Diagnostics Group and Swiss 4D Lifetec AG become strategic partners

December 21, 2022. Dresden-based Molecular Diagnostics Group (MDG) and Swiss-based 4D Lifetec AG become strategic partners. Both companies signed a non-exclusive cooperation agreement. The aim is to industrialize a blood test developed by 4D Lifetec for the early detection of cancer. This novel liquid biopsy procedure, the 4D Lifetest, has the potential to detect various types of cancer at an early stage. The plan is to set up industrial production of the assay kits and automate the 4D Lifetest workflow in order to facilitate its high-throughput application for laboratory diagnostics.

Both companies are highly specialized experts in the field of cancer diagnostics. 4D Lifetec is a pioneer in non-genomic liquid biopsy cancer diagnostics. Liquid biopsies make it possible to monitor a cancer patient’s disease progression at any time using a simple blood sample. The Swiss company has developed a special blood test for this purpose. It is based on a new transformational biomarker that is particularly suitable for the early detection of cancer. The 4D Lifetest Lung Dx is the company’s flagship product and the first CE IVD registered assay (medical device certification for in vitro diagnostics) that can non-invasively assess the development of lung cancer at the earliest stage. As such, the test represents a groundbreaking advance in addressing the catastrophic mortality rates of lung cancer patients. In addition, the 4D Lifetest helps clarify the diagnosis and protects patients who do not have cancer from the often unpleasant and invasive procedures used to find the exact cause of the disease. In the future, 4D Lifetec plans to further expand the high throughput capacity of its assay and apply it to detect other cancer types such as breast, prostate and colorectal cancer.

As part of the strategic partnership, MDG will make an important contribution to helping 4D Lifetec to succeed. As an experienced developer and producer of diagnostic tests, MDG has the necessary facilities to carry out the industrial production of the required test kits. The build-up of production will start in the spring of 2023, which is intended to meet the expected increase in demand from the current market launch of the 4D Lifetest. “With this partnership, we are laying an important foundation for the successful expansion of our 4D Lifetest business in Europe and the USA,” says Arne Faisst, CEO of 4D Lifetec.

In addition, MDG brings to the partnership its expertise in the development, manufacturing and distribution of molecular tests and related instruments. “We are a highly competent partner for the automation of assays developed by 4D Lifetec,” says Willi Zörgiebel, CEO of MDG.

“The same applies to our expertise in precision diagnostics,” says Zörgiebel. In the medium term, the two partners are looking into the joint development of oncological diagnostic solutions to combine the exceptionally high sensitivity of the 4D Lifetest in early detection with more advanced molecular precision tests for patient stratification. Molecular precision diagnostics can be used to determine precisely which type of cancer is at the center of the disease and which therapy approach is most promising.

Norman Gerstner, CEO of BIOTYPE GmbH (a company of MDG) adds: “The molecular data obtained in this way enable faster and more comprehensive cancer diagnostics. Therapies can then be better individualized, which significantly improves treatment success. This brings us a step closer to our shared vision in the MDG: to make clinically meaningful and affordable cancer diagnostics available for routine patient care.”

About Molecular Diagnostics Group

The Molecular Diagnostics Group (MDG) is a group of companies comprising BIOTYPE GmbH, qualitype GmbH and ROTOP Pharmaka GmbH. The group combines expertise in molecular diagnostics, nuclear medicine and theranostics, as well as bioinformatics. Its overarching goal is to develop and commercialize innovative methods for precision diagnostics in Personalized Medicine.

BIOTYPE develops, produces and distributes molecular and in vitro diagnostic kits, systems and services for the detection and quantification of RNA and DNA markers within the Group. The tests support diagnosis and therapy in oncology, hemato-oncology, and DNA analysis in forensics. As a specialized Contract Development and Manufacturing Organization (CDMO), Biotype helps other companies overcome their challenges in bringing new molecular diagnostic products to market. BIOTYPE distributes products throughout Europe through its own distribution network and is currently expanding internationally.

qualitype is a software system provider for digital laboratory and production processes. Since 2001, qualitype has been developing specialized software products and implementing individual software and consulting projects internationally. In the areas of laboratory management (LIMS), DNA analytics, laboratory equipment software and supply chain, qualitype offers a high level of professional and technical consulting expertise.

ROTOP Pharmaka GmbH is a Saxon pharmaceutical company that develops, manufactures and distributes radiopharmaceutical products for diagnostics and therapy worldwide, as well as providing CDMO services for theranostic radiopharmaceuticals. ROTOP is the only manufacturer in Germany of technetium-99m kits, which are used, for example, in cancer diagnostics and for diagnosing heart and kidney function. The company relies on close cooperation with the Helmholtz-Zentrum Dresden-Rossendorf (HZDR) as well as with research institutions in the region. With over 150 employees, ROTOP is one of the largest pharmaceutical companies in Saxony.

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About 4D Lifetec AG

4D Lifetec AG is one of the pioneering companies in non-genomic liquid biopsy cancer diagnostics. 4D Lifetest™ Lung Dx is the company’s flagship product, marketed with an initial focus on the diagnosis of early stage lung cancer. With its proprietary transformational DDS biomarker, 4D Lifetest™ has multiple opportunities to expand its market reach, become a key element in the diagnostic cascade for other major cancers, and support other genetic liquid biopsy methods with its high sensitivity for early detection. Additional applications (4D Lifetest™ Breast Dx, 4D Lifetest™ Prostate Dx, 4D Lifetest™ Colon Dx) are already CE IVD certified and ready to access additional markets worldwide.

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Press contact:
Dr. Wilhelm Zörgiebel,
CEO MDG Molecular Diagnostics Group GmbH,
Phone +49 (0)351 8838200,