| Basic Patient Information4-10 | ||
|---|---|---|
| Patient Name XXXXX Birthdate XX/XX/XXXX Diagnosis Non-small cell lung carcinoma | Ordering Physician Dr X Medical Facility XXXXX Pathologist Dr Y | Test Solid Tumor Profile by NGS Specimen FFPE Collected on XX/XX/XXXX Received on XX/XX/XXXX Reported on XX/XX/XXXX |
| Biomarker Results Summary | |||
|---|---|---|---|
| Tier 4-6,9,10 | Biomarker4-9 | Allele Frequency (VAF)5-8 | Targeted Therapy5-8 |
| I | Biomarker 1 (exon A deletion) | 50% | Treatment X and Treatment Y are indicated as a targeted therapy for Biomarker 1 (exon A deletion). Treatment Z may be contraindicated. Treatment AA is being studied in clinical trials for this biomarker. |
| Interpretive Summary |
|---|
| Histological Diagnosis4,6,9,10 Adenocarcinoma of the lung |
| Test Result Interpretation5,6 The Biomarker 1 (exon A deletion) variant is known to be oncogenic. Treatment X and Treatment Y are FDA approved for this variant in these types of cancer: NSCLC, colorectal cancer. Treatment X has a category-1 preferred recommendation for this alteration in the NCCN treatment guidelines for NSCLC and Treatment Y has a category-1 recommendation for this alteration in the NCCN treatment guidelines for NSCLC. Tumors with Biomarker 1 (exon A deletion) variant may develop resistance to certain treatments. Additionally, clinical studies have demonstrated that Treatment Z may be less effective for patients with this biomarker. |
| Pertinent Negatives5,6 No other clinically relevant molecular alterations detectable by this assay were identified. Pertinent negatives include but are not limited to the absence of X mutation, Y rearrangement, or C rearrangement. |
| Clinical Trials6,7 Biomarker 1 (exon A deletion) is associated with NCTXXXXXXXX. |
| Detailed Interpretation5-7 | |
|---|---|
| Biomarker 1 (exon A deletion) | Biomarker 1 is a transmembrane receptor tyrosine kinase. Numerous variants of the gene have been identified and investigated for their role in oncogenesis and sensitivity/resistance to targeted therapy. NCCN recommends TKIs as 1L therapy in patients with NSCLC whose tumors harbor Biomarker 1 (exon A deletion). |
| Variants of Unknown Clinical Significance4-6,8,9 |
|---|
| Gene A (XX%), Gene B (XX%), Gene C (XX%) |
| Test Description, Limitations, & Laboratory4-6,9,10 |
|---|
This NGS test is designed to detect variants present in any FFPE tissue from solid tumors. The test is designed to detect alteration types M, N, and O in a select group of genes. This test has an analytical sensitivity for detecting YY% alteration type M and YY% alteration type N in a background of non-mutated DNA sequence. The genes tested include Gene A, Gene B, Gene C, Biomarker 1, … Laboratory NameAddressLaboratory Director |
| Clinical Trials6,7 | |
|---|---|
| Biomarker 1 (exon A deletion) | NCTXXXXXXXX, A Phase 1/2 Study to Assess DRG-0001, an Oral Biomarker 1 Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer Locations: Alabama, Arizona, California… |
1L, first-line; CDx, companion diagnostic; cfDNA, cell-free DNA; CHIP, clonal hematopoiesis of indeterminate potential; CNV, copy number variant; ctDNA, circulating tumor DNA; DNA, deoxyribonucleic acid;
FDA, U.S. Food and Drug Administration; FFPE, formalin-fixed, paraffin-embedded; MSI, microsatellite instability; MSI-H, microsatellite instability-high; NCCN, National Comprehensive Cancer Network;
NGS, next-generation sequencing; NSCLC, non–small-cell lung cancer; TKI, tyrosine kinase inhibitor; TMB, tumor mutation burden; VAF, variant allele frequency.
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