Oncology Diagnostics

*Oncomine Dx Express Test (US) Abbreviated Intended Use:  The Oncomine Express Test is indicated as a companion diagnostic (CDx) to identify non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations for treatment with ZEGFROVY™ (sunvozertinib) in accordance with the approved therapeutic product labeling. The Oncomine Dx Express Test detects biomarkers recommended by professional guidelines for multiple solid tumors, including substitutions, insertions, and deletions in 42 genes, copy number variants in 10 genes, and fusions or splice variants in 18 genes.

**Oncomine Dx Express Test (CE-IVD) Abbreviated Intended Use: The Oncomine Dx Express Test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology and the Ion Torrent Genexus Dx System to detect deletions, insertions, substitutions, and copy number gain present in 42 genes and fusions in 18 genes from DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples. The Oncomine Dx Express Test also detects deletions, insertions and substitutions in 42 genes and fusions in 7 genes from cfTNA extracted from plasma samples. The Oncomine Dx Express Test is intended to provide clinically relevant tumor mutation profiling information to be used by qualified health care professionals in accordance with professional guidelines as an aid in therapy management of cancer patients with solid malignant neoplasms using FFPE samples and as an aid in therapy management of cancer patients with non-small cell lung cancer using plasma samples. It is not conclusive or prescriptive for labeled use of any specific therapeutic product.

†Oncomine Dx Target Test Abbreviated Intended Use: The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high-throughput, parallel sequencing technology to detect single-nucleotide variants (SNVs), insertions, and deletions in 23 genes from DNA and fusions in ROS1 and RET from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non–small cell lung cancer (NSCLC), IDH1 R132 mutations from FFPE tumor tissue samples from patients with cholangiocarcinoma (CC) and RET SNVs, MNVs, and deletions from DNA isolated from FFPE tumor tissue samples from patients with medullary thyroid cancer (MTC), and RET fusions from RNA isolated from FFPE tumor tissue samples from patients with thyroid cancer (TC) using the Ion PGM Dx System.