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Tute Genomics Platform Selected to Provide Clinical Interpretation for Lineagen's NextStepDx PLUS Next-Generation Sequencing-Based Diagnostic Test
Date:7/10/2014

PROVO, Utah, July 10, 2014 /PRNewswire-iReach/ -- Tute Genomics, the leader in genome annotation and interpretation, today 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.  "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 journalNature, was named one of Time magazine's Top 10 Medical Breakthroughs of 2009. 

About Tute Genomics

Tute Genomics offers innovative cloud-based solutions to accelerate genetic discovery and enable precision medicine. Tute developed a clinical genome interpretation platform that assists researchers in identifying disease genes and biomarkers, and assists clinicians/labs in performing genetic diagnosis. Given sequencing data from whole genomes or panels of genes, Tute returns over 125 annotations on variants and genes, performs family-based and case/control analyses to identify causal disease genes, and generates clinical reports for clinicians to focus on clinically relevant and actionable findings. Tute is built on the expertise that developed ANNOVAR, the most widely used genome annotation & interpretation technology with over 750 scientific publications. The genome revolution is here, and Tute envisions a future where clinical reports on genomes are interactive and integrated into medical records, and aims to be the "dropbox of genomes" for clinicians and patients alike. To learn more please visit www.tutegenomics.com.

About Lineagen

Based in Salt Lake City, Utah, Lineagen's mission is to accelerate and enhance the diagnostic evaluation of medical conditions so that the best possible outcomes can be achieved for patients and their families.  Our first commercial offering, FirstStepDx PLUS, provides physicians with a fully integrated genetic testing, counseling, and developmental screening service to aid in the diagnostic evaluation of individuals with ASD or other disorders of childhood development.  In addition to our deep commitment to ASD and developmental delay, we have ongoing scientific programs in the areas of multiple sclerosis (MS) and chronic obstructive pulmonary disease (COPD). For additional information, please visit www.lineagen.com.

About FirstStepDx PLUS

Lineagen's FirstStepDx PLUS and related autism-risk screening services (www.mchat.org) have been developed with the specific intention of helping physicians, patients, and families navigate the diagnostic "odyssey" of individuals with ASD and other disorders of childhood development.  Chromosomal microarray (CMA) genetic testing is medically recommended for individuals with ASD and other disorders of childhood development so that a genetic cause in these individuals can be identified earlier and more efficiently.  The FirstStepDx PLUS test includes genetic counseling, the most advanced, customized CMA clinically available, and a detailed, personalized report created specifically for each individual tested.  FirstStepDx PLUS is specifically designed to help parents, physicians, and other healthcare providers significantly shorten the time to clinical action, allowing access to proven clinical management and treatment approaches as early as possible.  The customized and proprietary CMA platform incorporated into FirstStepDx PLUS was developed in collaboration with Affymetrix under the Powered by Affymetrix program.  Lineagen's FirstStepDx PLUS and NextStepDx PLUS incorporate novel copy number and single nucleotide genetic variants that were validated in a 9,000-person genetic study by researchers affiliated with The Children's Hospital of Philadelphia (CHOP), the University of Utah, Golden Helix, Inc, and Lineagen (http://dx.plos.org/10.1371/journal.pone.0052239 and http://www.molecularautism.com/content/5/1/5).

The FirstStepDx PLUS genetic test was the first such test to be available as a fast and painless cheek swab (FirstStepDx PLUS Buccal), eliminating the need for a blood draw.  For more information about FirstStepDx PLUS, please call Lineagen at 888-888-OPEN (888-888-6736) or visit www.firststepdxplus.com.

Media Contact: Reid J. Robison, M.D. M.B.A., CEO, Tute Genomics, (858) 779-4363, reid@tutegenomics.com

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