A-ADAM, a new EU-funded project developing test systems for Alzheimer’s disease

Age-related neurodegenerative disorders represent a considerable medical and economic challenge for the health care sector. However, drug development for neurodegenerative disorders is severely hampered by a lack of predictive test systems in the preclinical phase.

To address this need, the EUREKA-Eurostars initiative of the European Union approved a project grant to E-PHY-SCIENCE in Valbonne, France, CeGaT GmbH in Tübingen, Germany and the NMI at the University of Tübingen. The project aims at the development of novel drug test systems for Alzheimer’s disease. A new animal model, an in vitro test system and a new diagnostic test will be generated by combining an established genetic animal model for Alzheimer’s disease with another animal model for age-dependent mitochondrial impairment.

The partners expect a considerable improvement over current drug test systems for age-dependent neurodegeneration which will speed up the validation of novel treatments.



CeGaT Receives Illumina NovaSeq™ 6000 System

CeGaT GmbH announced today the delivery of the first of two Illumina NovaSeq 6000 systems to further support its production scale for both clinical and translational research.

Joining CeGaT’s fleet of HiSeq® 4000, HiSeq 2500, and MiSeq® instruments, the newest Illumina platform released in March 2017 – NovaSeq 6000 instrument with S2 flowcell configuration – can now sequence up to 130 human exomes in 29 hours. That is an increase in output by 30% and twice faster than the HiSeq 4000 platform. By the end of 2017 when the S4 flowcell will be launched, the capability of sequencing 50 human genomes in approximately 2 days will pave the way towards future advances in clinical genomics and precision medicine. With the implementation of NovaSeq, CeGaT can shorten the turnaround time from sample to data and offer its customers the state-of-the-art sequencing technology.

Since it was founded in 2009 CeGaT has pioneered the approach of combining genetic diagnostics with NGS by offering various large diagnostic panels. Trio exome diagnostics, whole genome, and whole transcriptome have been added to an already extensive NGS portfolio. Different flavors of RNA-Seq, ranging from normal- to low-input or at the single-cell level, long or small RNA, coding or non-coding RNA, can all be done at CeGaT. An integrative genomics approach by combining whole exome and whole transcriptome can further provide clinically actionable information that could impact treatment decisions. Each method has been adapted to challenging material, i.e. FFPE, cell-free DNA, CTC, LCM, or degraded samples.

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CeGaT Obtains CLIA Certification, Final Step Towards U.S. Market Entry

CeGaT GmbH, a leading global genetic testing provider focused on large panel and trio-exome diagnostics, has obtained its CLIA certification.

After receiving CAP accreditation in 2016, CeGaT has been granted Clinical Laboratory Improvement Amendments (CLIA) certification by The Centers for Medicare & Medicaid Services (CMS), ensuring compliance with all standards required to process Human DNA samples originating from the United States. Dr. Eva Oberhettinger, Senior Quality Manager at CeGaT, states: “Receiving CLIA certification underscores the high quality standards of our laboratory and confirms the high accuracy and reliability of CeGaT’s proprietary genetic tests.”

The CLIA certification marks an important milestone for the company. CeGaT’s subsidiary B. Bran CeGaT LLC, based in Pennsylvania, will be responsible for U.S. operations. The company’s management expects accelerated growth for the years ahead. Managing Director Dr. Dirk Biskup: “The CLIA accreditation is a recognition and confirmation of our industry-leading quality systems. The whole CeGaT team is aware that we are handling human samples and that a fast and correct diagnosis is of utmost importance for the patient. With CLIA we are now looking forward to expanding our business in the United States.”

Additional to CLIA and CAP, CeGaT is accredited according to DIN EN ISO 15189:2014 since 2011. The company’s portfolio now comprises all important accreditations and certifications necessary to distribute its human genetics services around the globe.

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CeGaT receives BMBF funding for research into new methods in cancer diagnostics (liquid biopsy, analysis of circulating tumor DNA in the blood)

CeGaT GmbH has received 500,000 euros in funding under the initiative KMU-Innovativ: Biotechnologie-BioChance of the German Federal Ministry of Education and Research. The goal is to establish methods for the analysis of blood-circulating tumor DNA (cell-free DNA, cfDNA) in the context of cancer diagnostics. This would make the existing molecular genetic mutation analysis at CeGaT available to further patients, who, for medical reasons, cannot undergo a tissue biopsy.

Dying cells often release fragments of their genome, cfDNA, into the blood stream. Recent scientific findings suggest that tumor-specific mutations in the cfDNA can be detected by using modern, highly sensitive, molecular-genetic methods. Consequently, it may be possible to identify these individual mutations by examining an easily obtained blood sample, also known as a liquid biopsy. This makes it possible to derive recommendations for specific treatments, tailored to the patient.

In addition to an initial diagnosis, the analysis of cfDNA also opens up the possibility of close monitoring of cancer. Pioneering investigations show that in many cases this method can detect the progress or the recurrence of a tumor at very early time points. This makes cfDNA-based diagnostics a promising addition to the currently available imaging methods and tumor marker studies.

CeGaT receives accreditation from the College of American Pathologists (CAP)

CeGaT is now accredited by the College of American Pathologists and meets the highest standards of clinical laboratory and diagnostic practice.

After the successful laboratory inspection by the College of American Pathologists (CAP) in March 2016, CeGaT has received CAP accreditation, and thus complements the existing accreditation according to DIN EN ISO 15189. Both the CAP accreditation and the accreditation according to DIN EN ISO 15189 cover the full diagnostic spectrum of CeGaT, including the next-generation sequencing (NGS)-based analysis methods. Therefore, CeGaT meets worldwide recognized standards in diagnostics which are only shared by a handful of German human genetic laboratories. Since CeGaT’s founding, the company has always been committed to highest quality of its diagnostic services.

Official press release CeGaT (pdf)

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