Courtagen Introduces Genomic Profiling Services in their Newly Licensed CLIA Lab
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Courtagen Life Sciences, Inc. has announced the introduction of their first genetic tests using next generation sequencing (NGS) technology, propriety bioinformatics platform and highly annotated, analytic capabilities to diagnose mitochondrial disease in children and adults. The Courtagen tests, which are designed to be highly sensitive, efficient and comprehensive, will address the significant need for a quicker, less invasive and more reliable diagnostic tool for this patient population. The company will expand the menu of test options later this year ultimately offering a combination of multiplex proteomic and NGS genomic assays, utilizing Illumina’s MiSeq® and HiSeq® platforms, as they continue rapid expansion of capabilities. Later this year, Courtagen intends to release the first version of its “omics app” that will enhance their physician client’s ability to quickly and easily incorporate the company’s proteomic and genomic testing results into the medical evaluation process.
Mitochondrial disease denotes a large group of disorders caused by dysfunctional mitochondria, which are generally the result of genetic mutation. In these disorders, the body lacks the ability to produce adequate energy to perform all of its functions. The body systems most dependent on this energy are the brain, muscle, heart, kidneys and liver. Courtagen’s initial tests, mtSEEKPDx™, use next-generation sequencing technologies to complete a deep heteroplasmy analysis of the Mitochondrial DNA genome involved in mitochondrial function and energy metabolism.
“Courtagen is committed to building a dynamic life sciences company leveraging our unparalleled breadth and depth of expertise in genomic sequencing and proteomic platforms,” said Brian McKernan, Chief Executive Officer of Courtagen Life Sciences. “We believe our initial genetic tests for Mitochondrial disease will provide a clinical meaningful tool to healthcare providers and patients, and will be the first step in our goal to enable precision medicine – diagnostics that are truly person-centered and multifaceted. I am extremely proud of the rapid progress the Courtagen team has made on moving our both our proteomic and genomic initiatives forward.”
Courtagen recently received certification from the U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 for its genomic sequencing laboratory in Woburn, Massachusetts and has also achieved Massachusetts State Licensing, enabling the company to begin processing clinical samples from most states. Courtagen is one of the few commercial service laboratories in the country that has received CLIA certification for Next-Generation Sequencing assays. Courtagen is also pursuing certification in the states of Maryland, Rhode Island, New York, Florida, Pennsylvania, and California.
