Responding to the growing worldwide demand for molecular diagnostic tests and services, B Braun Medical US and CeGaT GmbH have recently announced the establishment of B Braun CeGaT LLC, a new firm for the US diagnostics market, to be based at the Bethlehem, Pa, headquarters of B Braun Medical.

CeGaT GmbH is a diagnostics testing laboratory based in Tuebingen, Germany, and known for its development of diagnostic panels for identifying the pathogenic gene variations of patients. The company was cofounded in 2009 by Saskia Biskup, MD, PhD, and Dirk Biskup, PhD.

B Braun Medical Inc develops, manufactures, and markets innovative medical products and services for the healthcare industry. The company is a leader in technologies for infusion therapy and pain management.

Biskup

Dirk Biskup, PhD

“Pennsylvania is a fantastic centralized location for a molecular diagnostics business,” says Dirk Biskup, PhD, CEO of CeGaT. “After many years of experience in the design, sequencing, and analysis of diagnostic panels in Germany, we can offer a real value and treatment decision support to the clinicians in the US.”

The basis of CeGaT’s success is the application of high-throughput next-generation sequencing (NGS) to diagnostic testing, together with its up-to-date knowledge of hereditary genetic diseases.

Sanger-based gene-by-gene sequencing was previously considered the state of the art for detecting gene variations. However, such single-gene testing is unable to detect the disease-causing gene variation in 80 to 90% of all cases.

CeGaT’s approach overcomes this limitation through the use of diagnostic panels, employing NGS technologies to sequence all of the genes associated with a given disease simultaneously. This approach is much faster and considerably less expensive than classic Sanger-based sequencing.

Since launching its first panels in 2010, CeGaT has gone on to develop a total of 159 diagnostic panels, covering more than 1,800 individual genes. The panels cover a wide range of diseases, including tumor diagnostics, neuromuscular diseases, and epilepsy.

According to the company, the probability of finding a pathogenic gene variation is significantly enhanced by the use of NGS-based diagnostic panels, which evaluate all genes associated with a patient’s phenotype. The process results in a highly accurate and reliable medical report based on the findings of the sequencing run, the medical history of the patient, and relevant family information. The report enables the referring clinician to select the best possible therapy for each individual case.

Paul O’Connell, president of B Braun CeGaT LLC, adds, “It is our goal to serve the US healthcare market with a dedicated team and the highest possible standard in molecular diagnostics.”