Lineagen introduces FirstStep integrated genetic testing for early diagnostic evaluation of ASD, DD

Lineagen announces the launch of its FirstStep^Dx integrated genetic testing and counseling service to assist pediatricians and family physicians with the earlier, more accurate diagnostic evaluation of autism spectrum disorders (ASD) and developmental delay (DD). FirstStep^Dx testing identifies certain genetic factors associated with ASD and DD.

“FirstStepDx is at the forefront of a new personalized approach to healthcare delivery and is the first specialist service that empowers community pediatricians with recommended standard of care genetic testing and best-in-class counseling service.”

Early diagnostic evaluation of children with ASD is critical so that they can receive the earliest possible proactive intervention. Recent clinical data has shown that behavioral intervention therapy is effective in treating the symptoms of ASD in children as young as 18 months of age. The average age of diagnosis in the United States is currently between 4 and 5 years old, resulting in the loss of valuable time for treating these children.

FirstStep^Dx integrates the most advanced and comprehensive genetic testing technology with pre- and post testing-consultation, provided by Lineagen's certified genetic counselors. The American College of Medical Genetics now recommends the technology used in FirstStep^Dx's genetic testing service as standard of care for apparent DD, ASD, and other conditions of childhood development.

"We created FirstStep^Dx to help community-based pediatricians and families confront the often overwhelming challenges associated with the evaluation of children with autism spectrum disorders and apparent developmental delay. Our service is focused entirely on shortening their diagnostic odyssey," said Michael Paul, Ph.D., CEO of Lineagen. "FirstStep^Dx is at the forefront of a new personalized approach to healthcare delivery and is the first specialist service that empowers community pediatricians with recommended standard of care genetic testing and best-in-class counseling service."

The diagnosis of ASD and other conditions of childhood development can be slow, expensive, and frustrating for all involved. FirstStep^Dx addresses the backlogs and long waiting periods often associated with the evaluation of developmental disorders, by providing to the community physician the innovative molecular diagnostic tests and genetic counseling services that have been previously limited to specialist urban medical centers.

"Parents are often desperate to find an answer or a reason for their child's unique developmental problems," said Dr. Miguel Knochel, FAAP of the Payson Pediatrics Canyon View Medical Group in Utah. "I have used FirstStep^Dx with a number of patients where ASD is suspected or confirmed. In all of these cases, Lineagen's service has proven to be extremely useful in the evaluation process. The FirstStep^Dx genetic test result can be the final piece of the puzzle, helping me with the clinical management of my patients. Based on these experiences, I will offer FirstStep^Dx right away to all my patients with potential clinical features of ASD or other developmental delays, especially for children with distinctive facial features, minor anomalies or a family history of ASD."

"Lineagen treats us as family and has helped us throughout this process and experience," said Brigitte Kracl of Payson, Utah, the mother of a child with ASD-like symptoms whose diagnosis of Angelman syndrome was confirmed by FirstStep^Dx. "I can ask them anything and they help me to understand all I need to know. Lineagen changed our lives. We can now give our son the help and support he deserves and needs."