Tute Genomics has announced an agreement with Lineagen, Inc., to provide next-generation sequencing (NGS) analytics for Lineagen’s NextStepDx PLUS. Lineagen, focused on the diagnostic evaluation of neurodevelopmental and neurological disorders, currently offers FirstStepDx PLUS, a customized chromosomal microarray (CMA) testing service used by healthcare providers as a first-line genetic diagnostic test for individuals with developmental delay (DD), autism spectrum disorders (ASD) and other disorders of childhood development.
Later this year, the Company anticipates launching NextStepDx PLUS, a next-generation sequence-based test that is specifically designed to increase the clinical detection of single nucleotide genetic variants linked to ASD and other disorders of childhood development. ASD is the fastest-growing neurodevelopmental disability in the U.S., affecting approximately 1 in 88 children, including up to 1 in 58 boys.
“Tute Genomics’ NGS analysis platform can rapidly and accurately analyze complex whole exome data and generate customized clinical reports, and we are very pleased to partner with Tute as we prepare to launch NextStepDx PLUS later this year,” commented Michael Paul, Ph.D., CEO of Lineagen.
Paul continued, “Our new test identifies previously unknown genetic variants that confer a genetic risk of developing ASD, which Lineagen validated along with The Children’s Hospital of Philadelphia and the University of Utah. Together, Lineagen’s FirstStepDx PLUS and NextStepDx PLUS genetic testing service are expected to deliver the highest clinical detection rate clinically available for ASD and other disorders of childhood development.”
Reid Robison, M.D., M.B.A., CEO of Tute Genomics, said, “This new partnership between Lineagen and Tute will accelerate progress in this area, bringing help and answers to families and leading to increased scientific understanding of the neurobiology of Autism as a necessary step towards treatments.”
ASD Expertise of the Tute Genomics Team
Tute Genomics’ leadership team possesses leading expertise in ASD discovery. As a former researcher at the University of Utah, Dr. Robison conducted gene-finding studies in large extended pedigrees with ASD. He also has also been principal investigator for a number of early-stage clinical trials of novel therapeutics for ASD.
Kai Wang, Ph.D., President of Tute Genomics, has researched extensively the genetics of ASD and related psychiatric disorders. Dr. Wang led or participated in multiple copy number variation studies, genome-wide association studies and next-generation sequencing studies on ASD.
His study on common genetic variants associated with ASD, featured in a May 2009 issue of the journal Nature, was named one of Time magazine’s Top 10 Medical Breakthroughs of 2009.