Panel Update: Tumor Diagnostics

In accordance with the latest scientific findings, we are updating our somatic tumor panel. The total number of genes on this panel is now 710, up from 649. The panel now includes mutational load analysis of the tumor and also supports the examination of leukemia and lymphoma.

The current update was designed to enable personalized therapy decisions, determined by an interdisciplinary tumor board, addressing solid tumors, leukemia and lymphoma. We’ve added additional genes that, according to the latest scientific findings, are linked to the development, growth, disease outlook, drug metabolism, and tumor therapy outcome. The examination of selected translocations is now performed in 29 genes.

In addition to the reporting of these treatment-relevant gene changes, we are also expanding our medical reports by reporting the mutation load of the tumor. Data increasingly suggests that tumors with very high mutation load have increased numbers of neo-antigens on the cell surface, and may therefore respond particularly well to immunotherapeutic approaches, such as checkpoint inhibitors.

In the context of genetic counseling, it is also possible to carry out tumor diagnostics by performing a liquid biopsy (blood test). If you would prefer this option, please arrange a personal appointment.

In parallel to these changes, we have also updated our panel for the diagnosis of hereditary tumor diseases by expanding the number of analyzed genes from 110 to a total of 124. Genes associated with increased tumor risk in gastric carcinoma, Cowden’s syndrome, as well as tumors of the central nervous system have been added. Furthermore, several indications already included in the panel have been extended by the addition of the new genes.

Somatic Tumor Panel

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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