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.