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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Subsidiary of CeGaT obtains a new investor

Gut bacteria and microbiome: important fields for precision medicine in the future

The founder and sole shareholder of the private Asklepios clinics, Dr. Bernard große Broermann, has assumed a 40% shareholding of Center for Metagenomics, CeMeT GmbH. With the Tübiom project (www.tuebiom.de), CeMeT is building one of the world’s largest microbiome reference database. The aim is to better understand the influence of the gut bacteria in diseases such as cancer, Alzheimer’s disease and diabetes, as well as vitamin deficiencies. Just a few weeks ago, during an event organized by the German Newspaper DIE ZEIT, Dr. Broermann officially announced that Asklepios will intensify its engagement in the field of precision medicine.

The causes of many diseases are unknown and medication is currently only prescribed on a statistical basis. With precision medicine on the rise, a different approach is developing including evaluating genetic variants, the environment and other factors such as the bacteria populating the gut.

As part of this new involvement, the capital of CeMeT has been increased by several million Euros. The founding shareholders of CeMeT, the professors Ingo Autenrieth, Daniel Huson and Detlef Weigel from Tübingen, and CeGaT GmbH, remain part of the company and together hold 55.6% of the shares.

In 2016, more than 600 million dollars were invested into microbiome research. This research field is rapidly increasing and more and more research groups and companies have the need for microbiome analysis and interpretation. The importance of microbiome research is demonstrated by the launch of the “National Microbiome Initiative” by the American government earlier this year. In addition to the Tübiom project, CeMeT has been a service partner of universities and clinics in the field of microbiome analysis since it was founded in 2014. Analysis is performed using state of the art techniques.

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)

CeGaT adds HiSeq 4000 to its sequencing capacities

As of today, the HiSeq 4000 has been added to the routine diagnostics pipeline of CeGaT. The HiSeq 4000 belongs to the latest generation of Illumina sequencers. This expansion of our sequencing capacities enables us to better fulfill your project and diagnostics requests. The HiSeq 4000 is being used for research purposes (like exome and genome sequencing) as well as for our diagnostic panels.

In addition to the HiSeq 4000, CeGaT operates two HiSeq 2500, a MiSeq and multiple 96-well Sanger sequencers.

Non-invasive prenatal tests available by Cenata

Since the beginning of May 2015 the non-invasive prenatal test HarmonyTM is being performed in Germany by Cenata GmbH. Cenata GmbH was founded jointly by Labor Enders, CeGaT GmbH and Prof. Dr. Hinrichsen. The HarmonyTM test reliably detects the most common chromosomal disorders in unborn children.

Maternal blood already contains not only genetic information of the mother but also genetic information of the child from an early phase of pregnancy. This so-called “cell-free fetal DNA” (cffDNA) can be investigated for the presence of chromosomal disorders in the unborn child (e.g. trisomy 21 – “Down syndrome”) using the HarmonyTM test. All that is needed is a blood sample from the mother.

The advantages of the HarmonyTM prenatal test at a glance:

  • excellent detection rate of 99.7% for trisomy 21
  • very low false positive rate of 0.06% for trisomy 21
  • excellent clinical validation, e.g. the to date biggest clinical NIPT study with 18,955 patients
  • attractive price: 399 euros for trisomy 21, 18, 13
  • short throughput time of 4-6 working days
  • no restrictions on account of a heparin treatment

Further information about the HarmonyTM test and the test procedure can be found on the website of Cenata GmbH .

AriosaTM, HarmonyTM, and Harmony Prenatal TestTM are trademarks of Ariosa Diagnostics, Inc. ©2013 Ariosa Diagnostics, Inc. All rights reserved.