CeGaT receives California CLIA State License and Accreditation – expanding diagnostic services in California.
CeGaT GmbH is a CLIA certified laboratory for high complexity testing (CLIA# 99D2130225) approved by US authorities (Centers of Medicare & Medicaid Services- Clinical Laboratory Improvement Amendment Survey and Certificate Group) qualifying CeGaT to operate in 49 states or districts in the USA. CeGaT’s subsidiary B. Braun CeGaT, LLC, based in Pennsylvania, is responsible for North American operations.
In addition to the 48 states included previously, CeGaT has now received the CLIA license for California (#CDS00800902). We are excited to provide world-class genetic testing and diagnostics to customers in California.
Beyond CLIA and CAP, CeGaT is accredited according to DIN EN ISO 15189:2014. The company’s portfolio now comprises all significant accreditations and certifications necessary to distribute its human genetics services around the globe.
CeGaT GmbH, Tübingen (Germany), was founded by Saskia Biskup, MD, PhD, and Dirk Biskup, PhD, in 2009. The basis of CeGaT’s success is an established high-throughput process for the use of next generation sequencing (NGS) in diagnostic testing and the up-to-date knowledge of hereditary genetic diseases. CeGaT is a diagnostics company which is renowned for identifying the pathogenic gene variations in patients. Single gene testing (which was state-of-the-art until 2010) would not detect the causative gene variation in 80-90% of all cases. Consequently, CeGaT has invented and established Diagnostic Panels. By simultaneously sequencing all genes associated with a certain disease using next generation sequencing platforms, the probability of finding the causative gene variation is extremely high. In addition, this approach is faster and considerably less expensive than classical gene-by-gene sequencing. CeGaT has more than 120 employees and a subsidiary company B. Braun CeGaT, LLC in the United States. CeGaT also is involved in the following companies: CeMeT GmbH (Center for Metagenomics), CAG GmbH (Center for Animal Genetics) and Cenata GmbH (prenatal diagnosis).
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A significant increase in sensitivity leads to almost perfect coverage of all genes. Also new scientific findings have been incorporated. The Panel for Neuromuscular Diseases is now available in version seven.
The sensitivity of the new version has been increased from > 98.4 % to > 99.997 % in non-homologous regions. This results in almost perfect coverage of the panel. Furthermore, the panel’s gene sets have been revised and updated according to the latest scientific research (oder findings). In particular the gene set for congenital myasthenic syndromes and arthrogryposis (formerly NMD06) has been divided into two dedicated gene sets:
- Congenital myasthenic syndromes (29 genes, NMD13) (AGRN, ALG14, ALG2, CHAT, CHRNA1, CHRNB1, CHRND, CHRNE, CHRNG, COL13A1, COLQ, DOK7, DPAGT1, GFPT1, GMPPB, LAMA5, LRP4, MUSK, MYO9A, PLEC, PREPL, RAPSN, SCN4A, SLC18A3, SLC25A1, SLC5A7, SNAP25, SYT2, VAMP1)
- Arthrogryposis (33 genes, NMD14) (ACTA1, ADCY6, ADGRG6, ALG3, BICD2, CHST14, CNTNAP1, DNM2, ECEL1, ERBB3, ERGIC1, FBN2, FKBP10, GLDN, GLE1, LGI4, MYBPC1, MYH3, MYH8, NALCN, NEK9, PIEZO2, PIP5K1C, PLOD2, SYNE1, TNNI2, TNNT3, TOR1A, TPM2, UNC50, VIPAS39, VPS33B, ZC4H2)
Our large panel approach is cost and time efficient: We always sequence all 344 genes of the neuromuscular disease panel and analyze the ordered gene set. As a result, we can quickly expand the analysis to all other gene sets. Furthermore we offer to check all 344 genes of the neuromuscular disease panel for ACMG class 4 and 5 variants. All our diagnostic panels include a panel-wide deletion/duplication analysis – free of charge. We validate pathogenic deletions or duplications by means of MLPA or qPCR before we report them. The highest quality possible is our standard for diagnostics.