Altera Comprehensive tumor genomic profiling (CGP) to select the most effective cancer treatment

Make informed treatment decisions with comprehensive molecular genetic tumor profiling.

Gain in-depth insights into genomic alterations in the tumor and oncology biomarkers with Altera. The detailed sequencing report includes FDA-approved (U.S. Food and Drug Administration) treatments, emerging therapeutic approaches, and ongoing clinical trials targeting the identified mutations. Unlike other tumor profiling methods, Altera also enables circulating tumor DNA (ctDNA) monitoring using the Signatera test.

Objectives:

Somatic profiling, including:

• RNA sequencing (identification of fusions with established clinical significance and detection of novel fusions)
• Introns, promoters
• Tumor mutational burden (TMB). This is a measure of the number of mutations in the tumor genome. A high TMB may indicate a greater likelihood of a successful response to immunotherapy.
• Microsatellite instability (MSI). This biomarker reflects the presence of errors in the DNA repair system. A high level of MSI may indicate tumor sensitivity to immunotherapy, particularly immune checkpoint inhibitors.
• Use of immunohistochemistry (IHC), a method of staining proteins in tissue to identify specific tumor biomarkers.
• PD-L1 assessment — Programmed Death-Ligand 1. A protein that helps tumors “hide” from the immune system. Determining PD-L1 expression using immunohistochemistry (22C3 is the name of the antibody used) helps predict the response to immunotherapy.
• HER2 assessment — Human Epidermal Growth Factor Receptor 2. A protein that may be overexpressed in certain types of cancer (for example, breast or gastric cancer), which

Altera offers a comprehensive approach based on exome and transcriptome sequencing for comprehensive genomic profiling, with more than 500-fold coverage of 440 medically relevant genes listed here:

This demonstrates that Altera can be combined with Signatera to provide a more comprehensive approach to the management of patients with cancer.

Altera – for therapy selection based on molecular tumor profiling.

Signatera – for monitoring treatment response and detecting recurrence. (See additional information on our website in the Signatera testing section.)

Key benefits of using both tests:

• Preservation of biological material – one tissue sample is used for both tests.
• Simplified process – a single order and access to results through the physician portal.
• Long-term monitoring – enables tracking of disease dynamics over time.
• Logistical convenience – fewer procedures for the patient.
• Personalized treatment – based on molecular data.

Required biological material:

You must provide one of the following two types of tumor material:

• Paraffin-embedded tumor tissue block + 1 microscope slide with a tumor tissue section stained with hematoxylin and eosin (H&E)
• 2–20 unstained microscope slides with tumor tissue sections + 1 microscope slide with a tumor tissue section stained with hematoxylin and eosin (H&E)
• Venous blood (2 tubes of 10 mL each) and 1 tube (6 mL)