OncoKids® Cancer Panel

The OncoKids® cancer panel is a primer-based target enrichment, next-generation sequencing assay designed to detect diagnostic, prognostic and biologic markers for targeted therapy across the spectrum of pediatric cancers. These cancers include leukemias, sarcomas, brain tumors and embryonal tumors. OncoKids® is a targeted gene panel intended to guide the diagnosis and treatment of cancer in pediatric patients based on the genomic alterations specific to their tumor.

OncoKids®Cancer Panel

The DNA content of the OncoKids® panel consists of over 3,000 amplicons and covers the full coding regions of 44 cancer predisposition loci, tumor suppressor genes and oncogenes; hotspots for mutations in 82 genes; and amplification events in 24 genes. The RNA content includes over 1,400 targeted gene fusions associated with acute myeloid leukemia, acute lymphoblastic leukemia, childhood sarcomas, pediatric brain tumors and soft tissue tumors.

The assay requires 20 ng of DNA and 20 ng of RNA derived from blood, bone marrow, and fresh, frozen or formalin fixed tumor tissue (FFPE). The assay utilizes highly multiplexed Ion AmpliSeq™ primers and next-generation sequencing technologies to detect somatic variants, high-level gene amplifications and gene fusions. For the DNA component of the assay, the mean read depth is over 3,000x with greater than 90 percent on-target reads. For the RNA component, targeted fusion read counts vary between 1,000x and 100,000x in positive samples. Downstream data analysis utilizes Ion Reporter™ and a proprietary custom software suite for clinical analysis, Integrated Curation Environment (ICE), developed by CHLA’s Center for Personalized Medicine.

The OncoKids® clinical assay was validated by the Children’s Hospital Los Angeles Center for Personalized Medicine, which is certified by the College of American Pathologists under the Clinical Laboratory Improvement Amendments of 1988. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This test should not be regarded as investigational or for research use.

OncoKids® Panel Features

OncoKids® is a comprehensive gene panel developed for children and young adults with leukemia, solid tumors, sarcomas, brain tumors and embryonal tumors.

• Designed specifically for pediatric cancers by pediatric geneticists, oncologists and pathologists
• Developed and validated in a CAP/CLIA environment
• Utilizes 10x less sample material than other next-generation sequencing cancer assays; critical for pediatric patients with smaller tumors
• Incorporates both DNA and RNA to obtain a more detailed picture of a patient’s tumor profile
• Backed by pediatric specialists ready to discuss clinical cases or field any technical or scientific questions